<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02261428</url>
  </required_header>
  <id_info>
    <org_study_id>AttikonH</org_study_id>
    <nct_id>NCT02261428</nct_id>
  </id_info>
  <brief_title>Nasotracheal Suction With Tiemann Catheter Compared to the Classic Technique With the Suction Catheter</brief_title>
  <official_title>Randomized Controlled Study of Nasotracheal Suction With Tiemann Catheter Compared to the Classic Technique With the Standard One.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grigoriadis Konstantinos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Attikon Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study compares the effectiveness of Tiemann and Suction catheters, with regard to&#xD;
      attempts to enter the trachea and the time required for the procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The population of the study was twenty (20) patients, hospitalized in General and&#xD;
      Cardiothoracic ICU, mostly with respiratory failure of various etiologies, the majority of&#xD;
      which has complicated with Unit Myoneuropathy. This state confirmed by medical research&#xD;
      council (MRC) Sum score which gave a result less than 48/6011 which corresponds to thirteen&#xD;
      (13) patients in the total population of the study.&#xD;
&#xD;
      The randomization of the study achieved using the sealed envelopes method and associated with&#xD;
      the catheter to be first used in the suction9,10 (Tiemann or suction catheter).&#xD;
&#xD;
      Twenty (20) sealed envelopes were prepared from a team not related to the study. The sealed&#xD;
      envelopes had an inside paper with the sign &quot;T&quot; for the first ten (10) envelopes and &quot;N&quot; for&#xD;
      the rest ten (10) of them.&#xD;
&#xD;
      When a new patient met the criteria for this study, one sealed envelope was randomly selected&#xD;
      to determine the technique would come first: &quot;T&quot; for Tiemann technique or &quot;N&quot; for Suction&#xD;
      catheter technique.&#xD;
&#xD;
      Furthermore the following parameters tabulated for each patient:&#xD;
&#xD;
        -  Sex&#xD;
&#xD;
        -  Unit&#xD;
&#xD;
        -  Cause input&#xD;
&#xD;
        -  First catheter used&#xD;
&#xD;
        -  Second catheter used&#xD;
&#xD;
        -  Hospitalization day&#xD;
&#xD;
        -  Age&#xD;
&#xD;
        -  Possible causes weakness&#xD;
&#xD;
        -  Percentage oxygen mixture fraction of inspired oxygen (FiO2) and&#xD;
&#xD;
        -  Oxygen partial pressure (PaO2) before any action&#xD;
&#xD;
      In addition to the above, all the parameters needed for calculating the Sequential Organ&#xD;
      Failure Assessment score (SOFA) were tabulated, such as:&#xD;
&#xD;
        -  Bilirubin&#xD;
&#xD;
        -  The Glasgow Coma Score&#xD;
&#xD;
        -  Platelets&#xD;
&#xD;
        -  Mean arterial pressure&#xD;
&#xD;
        -  Creatinine and urine 24 hours&#xD;
&#xD;
      Finally, it was recorded for each patient before and after the two catheterizations as&#xD;
      indicators of disturbance and physiological burden attached to the intervention:&#xD;
&#xD;
        -  The systolic and diastolic blood pressure&#xD;
&#xD;
        -  The respiratory rate&#xD;
&#xD;
        -  The heart rate&#xD;
&#xD;
        -  The saturation of hemoglobin&#xD;
&#xD;
        -  The blood gases, which recorded the partial pressure of oxygen (PaO2), carbon dioxide&#xD;
           carbon dioxide partial pressure (PaCO2), the Ph and bicarbonates (HCO3).&#xD;
&#xD;
      A first check took place to identify each patient who met the admission criteria for the&#xD;
      study.&#xD;
&#xD;
      The procedure required two people skilled in the nasotracheal suction (NTS), the first one to&#xD;
      perform the NTS and the other one to record the time and the attempts needed, and it was&#xD;
      beginning by correcting the posture of each patient on the bed, when the Great Trochanter was&#xD;
      more than 20 centimeters away from the hinge of the bed.&#xD;
&#xD;
      The pillow beneath the patient's head was removed to have an extended position, the first&#xD;
      blood gas analysis was done and the parameters mentioned above were recorded in the relevant&#xD;
      tables.&#xD;
&#xD;
      To determine the access of the trachea, it was used a stethoscope to hear turbulent flow on&#xD;
      the anterior surface of the chest.&#xD;
&#xD;
      The whole procedure comprises two &quot;steps&quot;:&#xD;
&#xD;
      a) Achieving of the entrance into the nasopharynx b) Achieving of the entrance into the&#xD;
      trachea&#xD;
&#xD;
        1. To achieve the entrance into the nasopharynx:&#xD;
&#xD;
             -  It was selected the opposite nostril that Levine was placed.&#xD;
&#xD;
             -  The insertion of the catheter was always opposite to the medial canthus of the eye.&#xD;
&#xD;
             -  If it was found resistance and the catheter was not inserted to the nasopharynx, it&#xD;
                was pulled slightly outwardly and then inwardly.&#xD;
&#xD;
           Each kind of micromanipulation recorded as attempt. The maximum number of attempts were&#xD;
           agreed in Protocol Design (beyond which the attempts would stop) was five (5). In fact,&#xD;
           in no cases was exceeded the limit of five attempts.&#xD;
&#xD;
           The time recorded corresponds to the time needed for the successful advancement of the&#xD;
           catheter in the nasopharynx through the nostril (T1).&#xD;
&#xD;
        2. Achieving of the entrance into the trachea:&#xD;
&#xD;
      The successful insertion of the catheter into the trachea was confirmed by another member of&#xD;
      the team using stethoscope and was determined by:&#xD;
&#xD;
      i. Hearing of turbulent flow when closing the &quot;fingertip&quot; ii. Insertion without resistance&#xD;
      iii. Tickly cough during the insertion.&#xD;
&#xD;
      The insertion to trachea was considered to be unsuccessful as the catheter insert into the&#xD;
      esophagus and thus:&#xD;
&#xD;
      i. There was no production of turbulent airflow when the hole of &quot;fingertip&quot;was closed ii. It&#xD;
      was found resistance during the insertion of the catheter iii. There was a grimace of disgust&#xD;
      on the patient's face. As the insertion was considered to be unsuccessful according to the&#xD;
      above conditions, catheter was drawn slightly outward (less than one centimeter) and&#xD;
      redirected to the trachea.&#xD;
&#xD;
      Each kind of micromanipulation recorded as attempt. The maximum number of attempts were&#xD;
      agreed in Protocol Design was ten (10). Beyond the above limit the insertion was considered&#xD;
      to be unsuccessful and repeated after half an hour15 with the other catheter (half an hour is&#xD;
      the sufficient time for the patient to return to his initial condition).&#xD;
&#xD;
      The time of the second &quot;step&quot; recorded, corresponds to the time needed for the successful&#xD;
      promotion of the catheter from the nasopharynx to the trachea (T2).&#xD;
&#xD;
      Finally it was recorded the time needed for each suction which was tabulated below as (T3).&#xD;
&#xD;
      The summation of (T1), (T2) and (T3) was reflected the total time needed for the whole&#xD;
      procedure which was followed by a new blood gas analysis.&#xD;
&#xD;
      All parameters were recorded by the team involved to the study. The catheters used for this&#xD;
      study were 14 French dia. of the same industry and from the same material (medical PVC).&#xD;
&#xD;
      As it was mentioned above, the whole idea based on the J-shape of the Tiemann catheter which&#xD;
      is useful for the orientation of the catheter during the insertion to the nasopharynx first&#xD;
      and then into the trachea and placed always downwards.&#xD;
&#xD;
      The oxygen face mask was maintained during the insertion of the catheter in order to continue&#xD;
      the patient's oxygenation and avoid hypoxemia. This was achieved by leaving outside the&#xD;
      oxygen face mask only the opposite nostril of the nasogastric tube.&#xD;
&#xD;
      No extra oxygen was given to patients before the procedure as pre-oxygenation.&#xD;
&#xD;
      The size of the sample was calculated based on a pilot study and was determined to twenty&#xD;
      (20) patients were not included in the main study. Thus ten (10) patients underwent an equal&#xD;
      number of nasotracheal suctioning with Tiemann catheter and ten (10) with Suction catheter.&#xD;
&#xD;
      For standard deviation σ1=3.9, and an error α=0,05 and power 80, the sample size must be&#xD;
      bigger than twelve (12).&#xD;
&#xD;
      From all the above the investigators summarize that the sample size of twenty (20) patients&#xD;
      was adequate.&#xD;
&#xD;
      For the statistical analysis was used the SPSS 20 Inc., Chicago, IL, and for paired values&#xD;
      the Paired T-Test and Wilcoxon Signed Rank Test.&#xD;
&#xD;
      For paired nominal parameters was used the McNemar Χ2 test. To determine normal&#xD;
      distributions, was used the Kolmogorov-Smirnov test. In the majority of cases data are&#xD;
      presented as Median (Range) in abnormal distributions and Mean (SD) in normal.&#xD;
&#xD;
      Odds ratio was used to quantify how strongly Tiemann associated with Suction catheter in&#xD;
      total attempts.&#xD;
&#xD;
      Significance was taken as P &lt; 0.05. To determine the difference in time needed by using the&#xD;
      two catheters was used Kaplan-Mayer analysis and long-rank test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Attempts Before Entering Trachea</measure>
    <time_frame>An average of 15 seconds</time_frame>
    <description>We count the required attempts to insert catheter into trachea (number of attempts)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Entering Trachea</measure>
    <time_frame>An average of 15 seconds</time_frame>
    <description>We count the required time needed to insert catheter into trachea (seconds).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Rate Immediately After Intervention</measure>
    <time_frame>Within 2 seconds after catheter withdrawal.</time_frame>
    <description>Recorded the respiratory rate (breaths per minute), immediately after intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate Immediately After Intervention</measure>
    <time_frame>Within 2 seconds after catheter withdrawal.</time_frame>
    <description>Immediately after each intervention recorded the heart rate (beats per minute).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure Immediately After Each Intervention</measure>
    <time_frame>Within 2 seconds after catheter withdrawal.</time_frame>
    <description>Immediately after each intervention recorded the systolic blood pressure (mmHg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure Immediately After Each Intervention</measure>
    <time_frame>Within 2 seconds after catheter withdrawal.</time_frame>
    <description>Immediately after each intervention recorded the diastolic blood pressure (mmHg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of Blood on Catheter Immediately After Each Intervention</measure>
    <time_frame>Within 2 seconds after catheter withdrawal.</time_frame>
    <description>Immediately after each intervention recorded the presence or absence of blood on the catheter (Yes or No).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>Catheter Tiemann</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We tested the ability of Tiemman catheter to access trachea and aspirate bronchial secretions, measuring number of attempts and time required for the intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suction catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We tested the ability of suction catheter to access trachea and aspirate bronchial secretions, measuring number of attempts and time required for the intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Catheter Tiemann</intervention_name>
    <description>We tested the ability of Tiemann catheter to access trachea in order to aspirate bronchial secretions in ICU patients</description>
    <arm_group_label>Catheter Tiemann</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Suction catheter</intervention_name>
    <description>We tested the ability of Suction catheter to access trachea in order to aspirate bronchial secretions in ICU patients</description>
    <arm_group_label>Suction catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ICU patients with nasogastric tube and spontaneous breathing without artificial airway&#xD;
&#xD;
          -  Inability to mobilize and handle secretions&#xD;
&#xD;
          -  Glasgow Coma Scale (GCS) &gt;12/15&#xD;
&#xD;
          -  PaO2/FiO2 ratio &gt;100&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active nasal bleeding&#xD;
&#xD;
          -  international normalized ratio (INR)&gt;3&#xD;
&#xD;
          -  Glasgow Coma Scale (GCS) &lt;11/15&#xD;
&#xD;
          -  Facial or basal cranial fractures&#xD;
&#xD;
          -  Tumor in trachea&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  ICU patients with endotracheal tube or tracheostomy tube&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dimitrios Angouras, MD</last_name>
    <role>Study Director</role>
    <affiliation>Athens University School of Medicine, Department of Cardiothoracic Surgery</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Theodoros Xanthos, MD</last_name>
    <role>Study Director</role>
    <affiliation>Athens University School of Medicine, Postgraduate program in CPR (moderator)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Konstantinos Grigoriadis, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Attikon Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katerina Flevari, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Attikon Hospital</affiliation>
  </overall_official>
  <reference>
    <citation>Pode D, Manny J. A simplified method for repeated nasotracheal suction. Surg Gynecol Obstet. 1984 Aug;159(2):173-4.</citation>
    <PMID>6463830</PMID>
  </reference>
  <reference>
    <citation>Brucia J, Rudy E. The effect of suction catheter insertion and tracheal stimulation in adults with severe brain injury. Heart Lung. 1996 Jul-Aug;25(4):295-303. doi: 10.1016/s0147-9563(96)80065-3.</citation>
    <PMID>8836745</PMID>
  </reference>
  <reference>
    <citation>Gemma M, Tommasino C, Cerri M, Giannotti A, Piazzi B, Borghi T. Intracranial effects of endotracheal suctioning in the acute phase of head injury. J Neurosurg Anesthesiol. 2002 Jan;14(1):50-4. doi: 10.1097/00008506-200201000-00010.</citation>
    <PMID>11773824</PMID>
  </reference>
  <reference>
    <citation>Marlow TJ, Goltra DD Jr, Schabel SI. Intracranial placement of a nasotracheal tube after facial fracture: a rare complication. J Emerg Med. 1997 Mar-Apr;15(2):187-91. doi: 10.1016/s0736-4679(96)00356-3.</citation>
    <PMID>9144060</PMID>
  </reference>
  <reference>
    <citation>Sloan EP, VanRooyen MJ. Suction catheter-assisted nasotracheal intubation. Acad Emerg Med. 1994 Jul-Aug;1(4):388-90. doi: 10.1111/j.1553-2712.1994.tb02651.x.</citation>
    <PMID>7614287</PMID>
  </reference>
  <reference>
    <citation>Roppolo LP, Vilke GM, Chan TC, Krishel S, Hayden SR, Rosen P, Trione M. Nasotracheal intubation in the emergency department, revisited. J Emerg Med. 1999 Sep-Oct;17(5):791-9. doi: 10.1016/s0736-4679(99)00085-2. Erratum In: J Emerg Med 2000 Jan;18(1):145.</citation>
    <PMID>10499691</PMID>
  </reference>
  <reference>
    <citation>Saissy JM, Boussignac G, Cheptel E, Rouvin B, Fontaine D, Bargues L, Levecque JP, Michel A, Brochard L. Efficacy of continuous insufflation of oxygen combined with active cardiac compression-decompression during out-of-hospital cardiorespiratory arrest. Anesthesiology. 2000 Jun;92(6):1523-30. doi: 10.1097/00000542-200006000-00007.</citation>
    <PMID>10839900</PMID>
  </reference>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <results_first_submitted>October 13, 2014</results_first_submitted>
  <results_first_submitted_qc>March 15, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 17, 2015</results_first_posted>
  <last_update_submitted>March 15, 2015</last_update_submitted>
  <last_update_submitted_qc>March 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Attikon Hospital</investigator_affiliation>
    <investigator_full_name>Grigoriadis Konstantinos</investigator_full_name>
    <investigator_title>Physical Therapist</investigator_title>
  </responsible_party>
  <keyword>Nasotracheal suction, tracheal access</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All ICU patients were breathing spontaneously, had respiratory failure of various pathophysiological mechanisms, with impaired cough reflex</recruitment_details>
      <pre_assignment_details>Of the 30 patients screened during the run-in period between May 2014 and September 2014 they received nasotracheal suction all. 10 of them required for pilot study and 20 for the main study. The pilot study was designated as a separate study and the participants was not included in this record.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Catheter Tiemann First, Then Suction Catheter</title>
          <description>Participants first received nasotracheal suction with catheter Tiemann. After a washout period minimum of half hour they received a second nasotracheal suction with Suction catheter</description>
        </group>
        <group group_id="P2">
          <title>Suction Catheter First, Then Catheter Tiemann</title>
          <description>Participants first received nasotracheal suction with suction catheter. After a washout period minimum of half hour they received a second nasotracheal suction with catheter Tiemann.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10">Washout (30 minutes)</participants>
                <participants group_id="P2" count="10">Washout (30 minutes)</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The participants were non intubated ICU patients who had inadequate cough leading to the inability to mobilize their secretions. The inadequate cough is result of neuromuscular disorders, ICU neuromyopathy, abdominal pain due to surgery and low consiousness due to head injuries.</population>
      <group_list>
        <group group_id="B1">
          <title>Catheter Tiemann First, Then Suction Catheter</title>
          <description>Participants first received nasotracheal suction with catheter Tiemann. After a washout period minimum of half hour they received a second nasotracheal suction with Suction catheter</description>
        </group>
        <group group_id="B2">
          <title>Suction Catheter First, Then Catheter Tiemann</title>
          <description>Participants first received nasotracheal suction with Suction catheter . After a washout period minimum of half hour they received a second nasotracheal suction with catheter Tiemann.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <description>Αge categories were defined in order to reflect the age in relation to the sensitivity of the population it invasive interventions</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;60 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60-69 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>70-79 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;80 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Gender determines the behavior of the autonomic nervous system</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>SOFA</title>
          <description>Used to monitor the patient's condition during the stay in the intensive care unit (ICU).&#xD;
Both the mean and highest SOFA scores are predictors of outcome. An increase in SOFA score during the first 24 to 48 hours in the ICU provided a mortality rate of at least 50% to 95%. Scores less than 9 give prediction of mortality by 33%, while over 11 may be near or above 95%</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hospitalisation day</title>
          <description>Specifies the degree of ICU neuromyopathy associated with weakness cough.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt; 5 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 5 days, &lt; 10 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 10 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Attempts Before Entering Trachea</title>
        <description>We count the required attempts to insert catheter into trachea (number of attempts)</description>
        <time_frame>An average of 15 seconds</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Catheter Tiemann</title>
            <description>The number below represents the mean of attempts made wth catheter Tiemann.</description>
          </group>
          <group group_id="O2">
            <title>Suction Catheter</title>
            <description>The number below represents the mean of attempts made wth Suction catheter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Attempts Before Entering Trachea</title>
          <description>We count the required attempts to insert catheter into trachea (number of attempts)</description>
          <units>Attempts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.63" spread="2.24"/>
                    <measurement group_id="O2" value="6.79" spread="3.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.79</ci_lower_limit>
            <ci_upper_limit>8.73</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Entering Trachea</title>
        <description>We count the required time needed to insert catheter into trachea (seconds).</description>
        <time_frame>An average of 15 seconds</time_frame>
        <population>The 19 interventions with each catheter was used randomly</population>
        <group_list>
          <group group_id="O1">
            <title>Catheter Tiemann</title>
            <description>The number below represents the mean of time required to insert the trachea wth catheter Tiemann.</description>
          </group>
          <group group_id="O2">
            <title>Suction Catheter</title>
            <description>The number below represents the mean of time required to insert the trachea wth Suction catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Entering Trachea</title>
          <description>We count the required time needed to insert catheter into trachea (seconds).</description>
          <population>The 19 interventions with each catheter was used randomly</population>
          <units>Sec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.05" spread="10.074"/>
                    <measurement group_id="O2" value="20.06" spread="12.694"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Respiratory Rate Immediately After Intervention</title>
        <description>Recorded the respiratory rate (breaths per minute), immediately after intervention</description>
        <time_frame>Within 2 seconds after catheter withdrawal.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Catheter Tiemann</title>
            <description>The number below represents the mean of respiratory rate recorded immediately after insertion to trachea wth catheter Tiemann.</description>
          </group>
          <group group_id="O2">
            <title>Suction Catheter</title>
            <description>The number below represents the mean of respiratory rate recorded immediately after insertion to trachea wth Suction catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Rate Immediately After Intervention</title>
          <description>Recorded the respiratory rate (breaths per minute), immediately after intervention</description>
          <units>Βreaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.37" spread="7.544"/>
                    <measurement group_id="O2" value="25.79" spread="7.941"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Heart Rate Immediately After Intervention</title>
        <description>Immediately after each intervention recorded the heart rate (beats per minute).</description>
        <time_frame>Within 2 seconds after catheter withdrawal.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Catheter Tiemann</title>
            <description>The number below represents the mean of heart rate recorded immediately after insertion to trachea wth catheter Tiemann.</description>
          </group>
          <group group_id="O2">
            <title>Suction Catheter</title>
            <description>The number below represents the mean of heart rate recorded immediately after insertion to trachea wth Suction catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate Immediately After Intervention</title>
          <description>Immediately after each intervention recorded the heart rate (beats per minute).</description>
          <units>Βeats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.21" spread="15.623"/>
                    <measurement group_id="O2" value="86.53" spread="14.013"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Systolic Blood Pressure Immediately After Each Intervention</title>
        <description>Immediately after each intervention recorded the systolic blood pressure (mmHg).</description>
        <time_frame>Within 2 seconds after catheter withdrawal.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Catheter Tiemann</title>
            <description>The number below represents the mean of systolic blood pressure recorded immediately after insertion to trachea wth catheter Tiemann.</description>
          </group>
          <group group_id="O2">
            <title>Suction Catheter</title>
            <description>The number below represents the mean of systolic blood pressure recorded immediately after insertion to trachea wth Suction catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure Immediately After Each Intervention</title>
          <description>Immediately after each intervention recorded the systolic blood pressure (mmHg).</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143.37" spread="24.703"/>
                    <measurement group_id="O2" value="141.32" spread="19.136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diastolic Blood Pressure Immediately After Each Intervention</title>
        <description>Immediately after each intervention recorded the diastolic blood pressure (mmHg).</description>
        <time_frame>Within 2 seconds after catheter withdrawal.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Catheter Tiemann</title>
            <description>The number below represents the mean of diastolic blood pressure recorded immediately after insertion to trachea wth catheter Tiemann.</description>
          </group>
          <group group_id="O2">
            <title>Suction Catheter</title>
            <description>The number below represents the mean of diastolic blood pressure recorded immediately after insertion to trachea wth Suction catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure Immediately After Each Intervention</title>
          <description>Immediately after each intervention recorded the diastolic blood pressure (mmHg).</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.74" spread="13.482"/>
                    <measurement group_id="O2" value="60.32" spread="11.856"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Presence of Blood on Catheter Immediately After Each Intervention</title>
        <description>Immediately after each intervention recorded the presence or absence of blood on the catheter (Yes or No).</description>
        <time_frame>Within 2 seconds after catheter withdrawal.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Catheter Tiemann</title>
            <description>Presence of blood was found on Participants immediately after suctioning with catheter Tiemann</description>
          </group>
          <group group_id="O2">
            <title>Suction Catheter</title>
            <description>Presence of blood was found on Participants immediately after suctioning with Suction catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Presence of Blood on Catheter Immediately After Each Intervention</title>
          <description>Immediately after each intervention recorded the presence or absence of blood on the catheter (Yes or No).</description>
          <units>Catheters with presence of blood</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 months</time_frame>
      <desc>Presence of Blood on Catheter</desc>
      <group_list>
        <group group_id="E1">
          <title>Catheter Tiemann</title>
          <description>Participants received nasotracheal suction with catheter Tiemann.</description>
        </group>
        <group group_id="E2">
          <title>Suction Catheter</title>
          <description>Participants received nasotracheal suction with Suction catheter</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Presence of Blood on Catheter</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="20"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Mr. Konstantinos Grigoriadis ICU Physical Therapist</name_or_title>
      <organization>&quot;Attikon&quot; General University Hospital of Athens</organization>
      <phone>00302105832489</phone>
      <email>grigoriakost@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02261428
org study id: AttikonH
nct id: NCT02261428
lead sponsor: 
has dmc: Yes
The study compares the effectiveness of Tiemann and Suction catheters, with regard to
      attempts to enter the trachea and the time required for the procedure.
The population of the study was twenty (20) patients, hospitalized in General and
      Cardiothoracic ICU, mostly with respiratory failure of various etiologies, the majority of
      which has complicated with Unit Myoneuropathy. This state confirmed by medical research
      council (MRC) Sum score which gave a result less than 48/6011 which corresponds to thirteen
      (13) patients in the total population of the study.

      The randomization of the study achieved using the sealed envelopes method and associated with
      the catheter to be first used in the suction9,10 (Tiemann or suction catheter).

      Twenty (20) sealed envelopes were prepared from a team not related to the study. The sealed
      envelopes had an inside paper with the sign "T" for the first ten (10) envelopes and "N" for
      the rest ten (10) of them.

      When a new patient met the criteria for this study, one sealed envelope was randomly selected
      to determine the technique would come first: "T" for Tiemann technique or "N" for Suction
      catheter technique.

      Furthermore the following parameters tabulated for each patient:

        -  Sex

        -  Unit

        -  Cause input

        -  First catheter used

        -  Second catheter used

        -  Hospitalization day

        -  Age

        -  Possible causes weakness

        -  Percentage oxygen mixture fraction of inspired oxygen (FiO2) and

        -  Oxygen partial pressure (PaO2) before any action

      In addition to the above, all the parameters needed for calculating the Sequential Organ
      Failure Assessment score (SOFA) were tabulated, such as:

        -  Bilirubin

        -  The Glasgow Coma Score

        -  Platelets

        -  Mean arterial pressure

        -  Creatinine and urine 24 hours

      Finally, it was recorded for each patient before and after the two catheterizations as
      indicators of disturbance and physiological burden attached to the intervention:

        -  The systolic and diastolic blood pressure

        -  The respiratory rate

        -  The heart rate

        -  The saturation of hemoglobin

        -  The blood gases, which recorded the partial pressure of oxygen (PaO2), carbon dioxide
           carbon dioxide partial pressure (PaCO2), the Ph and bicarbonates (HCO3).

      A first check took place to identify each patient who met the admission criteria for the
      study.

      The procedure required two people skilled in the nasotracheal suction (NTS), the first one to
      perform the NTS and the other one to record the time and the attempts needed, and it was
      beginning by correcting the posture of each patient on the bed, when the Great Trochanter was
      more than 20 centimeters away from the hinge of the bed.

      The pillow beneath the patient's head was removed to have an extended position, the first
      blood gas analysis was done and the parameters mentioned above were recorded in the relevant
      tables.

      To determine the access of the trachea, it was used a stethoscope to hear turbulent flow on
      the anterior surface of the chest.

      The whole procedure comprises two "steps":

      a) Achieving of the entrance into the nasopharynx b) Achieving of the entrance into the
      trachea

        1. To achieve the entrance into the nasopharynx:

             -  It was selected the opposite nostril that Levine was placed.

             -  The insertion of the catheter was always opposite to the medial canthus of the eye.

             -  If it was found resistance and the catheter was not inserted to the nasopharynx, it
                was pulled slightly outwardly and then inwardly.

           Each kind of micromanipulation recorded as attempt. The maximum number of attempts were
           agreed in Protocol Design (beyond which the attempts would stop) was five (5). In fact,
           in no cases was exceeded the limit of five attempts.

           The time recorded corresponds to the time needed for the successful advancement of the
           catheter in the nasopharynx through the nostril (T1).

        2. Achieving of the entrance into the trachea:

      The successful insertion of the catheter into the trachea was confirmed by another member of
      the team using stethoscope and was determined by:

      i. Hearing of turbulent flow when closing the "fingertip" ii. Insertion without resistance
      iii. Tickly cough during the insertion.

      The insertion to trachea was considered to be unsuccessful as the catheter insert into the
      esophagus and thus:

      i. There was no production of turbulent airflow when the hole of "fingertip"was closed ii. It
      was found resistance during the insertion of the catheter iii. There was a grimace of disgust
      on the patient's face. As the insertion was considered to be unsuccessful according to the
      above conditions, catheter was drawn slightly outward (less than one centimeter) and
      redirected to the trachea.

      Each kind of micromanipulation recorded as attempt. The maximum number of attempts were
      agreed in Protocol Design was ten (10). Beyond the above limit the insertion was considered
      to be unsuccessful and repeated after half an hour15 with the other catheter (half an hour is
      the sufficient time for the patient to return to his initial condition).

      The time of the second "step" recorded, corresponds to the time needed for the successful
      promotion of the catheter from the nasopharynx to the trachea (T2).

      Finally it was recorded the time needed for each suction which was tabulated below as (T3).

      The summation of (T1), (T2) and (T3) was reflected the total time needed for the whole
      procedure which was followed by a new blood gas analysis.

      All parameters were recorded by the team involved to the study. The catheters used for this
      study were 14 French dia. of the same industry and from the same material (medical PVC).

      As it was mentioned above, the whole idea based on the J-shape of the Tiemann catheter which
      is useful for the orientation of the catheter during the insertion to the nasopharynx first
      and then into the trachea and placed always downwards.

      The oxygen face mask was maintained during the insertion of the catheter in order to continue
      the patient's oxygenation and avoid hypoxemia. This was achieved by leaving outside the
      oxygen face mask only the opposite nostril of the nasogastric tube.

      No extra oxygen was given to patients before the procedure as pre-oxygenation.

      The size of the sample was calculated based on a pilot study and was determined to twenty
      (20) patients were not included in the main study. Thus ten (10) patients underwent an equal
      number of nasotracheal suctioning with Tiemann catheter and ten (10) with Suction catheter.

      For standard deviation σ1=3.9, and an error α=0,05 and power 80, the sample size must be
      bigger than twelve (12).

      From all the above the investigators summarize that the sample size of twenty (20) patients
      was adequate.

      For the statistical analysis was used the SPSS 20 Inc., Chicago, IL, and for paired values
      the Paired T-Test and Wilcoxon Signed Rank Test.

      For paired nominal parameters was used the McNemar Χ2 test. To determine normal
      distributions, was used the Kolmogorov-Smirnov test. In the majority of cases data are
      presented as Median (Range) in abnormal distributions and Mean (SD) in normal.

      Odds ratio was used to quantify how strongly Tiemann associated with Suction catheter in
      total attempts.

      Significance was taken as P < 0.05. To determine the difference in time needed by using the
      two catheters was used Kaplan-Mayer analysis and long-rank test.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Number of Attempts Before Entering Trachea
time frame: An average of 15 seconds
description: We count the required attempts to insert catheter into trachea (number of attempts)
measure: Time to Entering Trachea
time frame: An average of 15 seconds
description: We count the required time needed to insert catheter into trachea (seconds).
measure: Respiratory Rate Immediately After Intervention
time frame: Within 2 seconds after catheter withdrawal.
description: Recorded the respiratory rate (breaths per minute), immediately after intervention
measure: Heart Rate Immediately After Intervention
time frame: Within 2 seconds after catheter withdrawal.
description: Immediately after each intervention recorded the heart rate (beats per minute).
measure: Systolic Blood Pressure Immediately After Each Intervention
time frame: Within 2 seconds after catheter withdrawal.
description: Immediately after each intervention recorded the systolic blood pressure (mmHg).
measure: Diastolic Blood Pressure Immediately After Each Intervention
time frame: Within 2 seconds after catheter withdrawal.
description: Immediately after each intervention recorded the diastolic blood pressure (mmHg).
measure: Presence of Blood on Catheter Immediately After Each Intervention
time frame: Within 2 seconds after catheter withdrawal.
description: Immediately after each intervention recorded the presence or absence of blood on the catheter (Yes or No).
arm group label: Catheter Tiemann
arm group type: Experimental
description: We tested the ability of Tiemman catheter to access trachea and aspirate bronchial secretions, measuring number of attempts and time required for the intervention
arm group label: Suction catheter
arm group type: Active Comparator
description: We tested the ability of suction catheter to access trachea and aspirate bronchial secretions, measuring number of attempts and time required for the intervention
intervention type: Device
intervention name: Catheter Tiemann
description: We tested the ability of Tiemann catheter to access trachea in order to aspirate bronchial secretions in ICU patients
arm group label: Catheter Tiemann
intervention type: Device
intervention name: Suction catheter
description: We tested the ability of Suction catheter to access trachea in order to aspirate bronchial secretions in ICU patients
arm group label: Suction catheter
criteria: 
gender: All
minimum age: 45 Years
maximum age: 85 Years
healthy volunteers: No
last name: Dimitrios Angouras, MD
role: Study Director
affiliation: Athens University School of Medicine, Department of Cardiothoracic Surgery
last name: Theodoros Xanthos, MD
role: Study Director
affiliation: Athens University School of Medicine, Postgraduate program in CPR (moderator)
last name: Konstantinos Grigoriadis, PT
role: Principal Investigator
affiliation: Attikon Hospital
last name: Katerina Flevari, MD
role: Study Chair
affiliation: Attikon Hospital
citation: Pode D, Manny J. A simplified method for repeated nasotracheal suction. Surg Gynecol Obstet. 1984 Aug;159(2):173-4.
PMID: 6463830
citation: Brucia J, Rudy E. The effect of suction catheter insertion and tracheal stimulation in adults with severe brain injury. Heart Lung. 1996 Jul-Aug;25(4):295-303. doi: 10.1016/s0147-9563(96)80065-3.
PMID: 8836745
citation: Gemma M, Tommasino C, Cerri M, Giannotti A, Piazzi B, Borghi T. Intracranial effects of endotracheal suctioning in the acute phase of head injury. J Neurosurg Anesthesiol. 2002 Jan;14(1):50-4. doi: 10.1097/00008506-200201000-00010.
PMID: 11773824
citation: Marlow TJ, Goltra DD Jr, Schabel SI. Intracranial placement of a nasotracheal tube after facial fracture: a rare complication. J Emerg Med. 1997 Mar-Apr;15(2):187-91. doi: 10.1016/s0736-4679(96)00356-3.
PMID: 9144060
citation: Sloan EP, VanRooyen MJ. Suction catheter-assisted nasotracheal intubation. Acad Emerg Med. 1994 Jul-Aug;1(4):388-90. doi: 10.1111/j.1553-2712.1994.tb02651.x.
PMID: 7614287
citation: Roppolo LP, Vilke GM, Chan TC, Krishel S, Hayden SR, Rosen P, Trione M. Nasotracheal intubation in the emergency department, revisited. J Emerg Med. 1999 Sep-Oct;17(5):791-9. doi: 10.1016/s0736-4679(99)00085-2. Erratum In: J Emerg Med 2000 Jan;18(1):145.
PMID: 10499691
citation: Saissy JM, Boussignac G, Cheptel E, Rouvin B, Fontaine D, Bargues L, Levecque JP, Michel A, Brochard L. Efficacy of continuous insufflation of oxygen combined with active cardiac compression-decompression during out-of-hospital cardiorespiratory arrest. Anesthesiology. 2000 Jun;92(6):1523-30. doi: 10.1097/00000542-200006000-00007.
PMID: 10839900
responsible party type: Sponsor-Investigator
investigator affiliation: Attikon Hospital
investigator full name: Grigoriadis Konstantinos
investigator title: Physical Therapist
mesh term: Muscle Weakness
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 