<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/NCT04447586</url>
  </required_header>
  <id_info>
    <org_study_id>101ΣΕ2/16-01-2020</org_study_id>
    <secondary_id>725/25/11/2019</secondary_id>
    <nct_id>NCT04447586</nct_id>
  </id_info>
  <brief_title>Soft Drink Straw as an Alternative Device of Creating Positive Expiratory Pressure (PEP) in Thoracic Surgery Patients</brief_title>
  <acronym>PEP</acronym>
  <official_title>Soft Drink Straw as an Alternative Device of Creating Positive Expiratory Pressure (PEP) in Thoracic Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Thessaly</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Attikon Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Thessaly</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Is there any possibility that patients who undergone thoracic surgery could use a simple soft&#xD;
      drink straw as an alternative PEP device? The present study was performed to test the&#xD;
      suitability and effect of a soft drink straw as an alternative Positive Expiratory Pressure&#xD;
      device in patients undergone thoracic surgery and includes two sub-exploratory areas.&#xD;
&#xD;
      Before and after the measurements, the volunteers' saturation, heart rate, respiratory rate,&#xD;
      systolic and diastolic blood pressure, dyspnea, thoracotomy pain and Cough Peak Expiratory&#xD;
      Flow was measured.&#xD;
&#xD;
      The first part of the research, that refers to the most appropriate command for exhalation&#xD;
      from a straw of a certain inner diameter (5mm), was carried out by using a device consisted&#xD;
      of drinking straw, disposable mouthpiece and manometer, which valued the developed pressures&#xD;
      during the exhalation attempts. Patients did not have visual contact with the manometer. The&#xD;
      effectiveness of two commands (Command A: &quot;blow continuously so that you feel little&#xD;
      resistance during exhalation&quot; and Command B: &quot;blow continuously so that you feel moderate&#xD;
      resistance during exhalation&quot;) was estimated by comparing the average of the developing&#xD;
      pressures for every command, that occur during exhalation, with the therapeutic range of&#xD;
      pressure. This part of the study was a cross-sectional transition and every volunteer&#xD;
      performed 3 attempts, for each command.&#xD;
&#xD;
      The second part of the research was conducted for the evaluation of the benefits of the use&#xD;
      of a drinking straw as an alternative device. A number of n = 8 volunteers (intervention&#xD;
      group), who were selected from the overall sample using the closed envelope method. Taking&#xD;
      into account the results of the first part of the research, the respondents were asked to&#xD;
      exhale as indicated by the command that was selected before, performing 3 sets of 10&#xD;
      repetitions, that included short breaks between sets. The remaining volunteers (n = 5)&#xD;
      consisted the control group.&#xD;
&#xD;
      Finally, all patients were re-examined in order to measure the Cough Peak Expiratory Flow ,&#xD;
      dyspnea, pain, saturation, heart and respiratory rate, and systolic and diastolic blood&#xD;
      pressure, after the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION&#xD;
&#xD;
      The use of positive expiratory pressure devices is considered beneficial in patients who have&#xD;
      undergone abdominal and thoracic surgery with an impact on blood gas measurement values, the&#xD;
      hospitalization length, the use of antibiotics and the pathology of the chest. Of course,&#xD;
      there are researchers who doubt the effectiveness of the method, mainly due to the fact that&#xD;
      it does not possibly reduce the risk of atelectasis, especially in patients who undergone&#xD;
      cardiac surgery. However, the method is very popular in physiotherapy, and the use of&#xD;
      alternative devices that create positive expiratory pressure, such as water bottles or&#xD;
      gloves, is suggested, especially in cases when the access to the classic devices is not easy,&#xD;
      mainly during the periods of crisis.&#xD;
&#xD;
      Coughing is a process that ensures the cleaning and protection of the airways. The outcome of&#xD;
      the thoracic surgery may often depend on the quality of the patient's cough postoperatively&#xD;
      which may put the patient at risk that could last for up to eight weeks. The effectiveness of&#xD;
      the cough can be assessed by measuring the peak cough flow using a peak flow meter, method&#xD;
      that many researchers in Europe and America prefer. Cough with a maximum expiratory flow over&#xD;
      160 L/min could ensure a safe extubation or decannulation of severely ill and postoperative&#xD;
      patients. Therefore, if there was a way leading to cough enhancement, this could be a&#xD;
      lifeline to the recovery of these type of patients.&#xD;
&#xD;
      PURPOSE&#xD;
&#xD;
      The present study was performed to test the suitability and effect of a soft drink straw as&#xD;
      an alternative positive expiratory pressure device in patients undergone thoracic surgery and&#xD;
      includes two sub-exploratory areas.&#xD;
&#xD;
      In the first one, it was investigated the most appropriate command of exhalation into a&#xD;
      specific internal diameter straw, whereas on the other hand, it was examined the improvement&#xD;
      of patient's overview by using the particular alternative device.&#xD;
&#xD;
      RESEARCH HYPOTHESIS&#xD;
&#xD;
      Is there any possibility of a simple soft drink straw being an alternative PEP device which&#xD;
      could improve the cough flow of patients who undergone thoracic surgery?&#xD;
&#xD;
      METHODOLOGY&#xD;
&#xD;
      The research was approved by &quot;ATTIKON&quot; University General Hospital (with reference number&#xD;
      725/25/11/2019) and by the University of Thessaly (with reference number 101SE2/16-01-2020).&#xD;
&#xD;
      The study was performed at the Cardiac Surgery Clinic of &quot;ATTIKON&quot; University General&#xD;
      Hospital and participated all the adult thoracic surgical patients, with no limit of age,&#xD;
      from 12-02-2020 to 08-03-2020 Patients beforehand, are informed with the purpose of the study&#xD;
      and necessarily sign the Patient Consensus Form for their participation in the study.&#xD;
&#xD;
      Sample:&#xD;
&#xD;
      The sample of present study included all adult patients that undergone thoracic surgery, with&#xD;
      no limit of age, with a mesosternal or lateral incision, who considered hemodynamically&#xD;
      stable, were supplied with an O2 mixture of below 50%, full-conscious, with systolic pressure&#xD;
      below 150 cmH20. The records were carried out on the 2nd and 3rd postoperative day.&#xD;
&#xD;
      Patients with history of chronic respiratory disease, with severe symptoms, tendency to&#xD;
      vomit, cardiac arrhythmia due to atrial fibrillation postoperatively, and patients with&#xD;
      angina were excluded from the study. The records were carried out in the morning or at noon&#xD;
      and were automatically stopped if patient had any difficulty, decrease in saturation ≤90,&#xD;
      feeling of dizziness, fainting and palpitations. The number of volunteers excluded from the&#xD;
      study was n = 4 (2 people due to dizziness during the sitting position, 1 person with a&#xD;
      tendency to vomit before the beginning of the process and 1 person due to re-intubation&#xD;
      before the beginning of the process).&#xD;
&#xD;
      Procedure:&#xD;
&#xD;
      All patients were beforehand informed about the purpose of the study and signed the Patient&#xD;
      Consensus Form in order to participate the study. Data, such as age, height and weight, type&#xD;
      of surgery and concomitant pathologies, if any, were collected. Patients' medical records&#xD;
      were examined to verify the collected information and find any indication that could have led&#xD;
      to their exclusion from the study. Records and measurements were begun only after&#xD;
      consultation with patient's doctor.&#xD;
&#xD;
      Each participant was placed in a sitting position, with his popliteal region of the knees&#xD;
      near the edge of the bed and stayed in this position for at least 2 minutes in order to be&#xD;
      checked that he won't develop any symptom such as discoloration of the face's skin, dizziness&#xD;
      or fainting. In case of appearance of any of the above symptoms, patient was placed back in a&#xD;
      supine position and the procedure stopped. Patients who felt a very light dizziness detected&#xD;
      by overview or oral evaluation, remained seated until the symptom passes and then records and&#xD;
      measurements were started. If the symptom continued, the procedure was stopped and patient&#xD;
      returned to the supine position.&#xD;
&#xD;
      In the first phase of the study, all volunteers' saturation and heart rate was recorded using&#xD;
      oximeter or monitor's indications, whereas the recording of respiratory rate followed by&#xD;
      placing one researcher's hands on the subject's epigastrium. Both systolic and diastolic&#xD;
      blood pressure were recorded with an analog pressure gauge, as well dyspnea (calibrated using&#xD;
      the borg scale) and thoracotomy pain, which was quantified using the numerical pain scale&#xD;
      (Numeric Rating Scale - oral application).&#xD;
&#xD;
      The maximum expiratory flow of air during coughing was estimated with a Peak Flow Meter (PFM)&#xD;
      device. Participants applied their lips to a disposable mouthpiece, which was connected to&#xD;
      the PFM and followed the command &quot;please cough hard inside the device&quot;. The value recorded&#xD;
      through the PFM device, which was the airflow during coughing, corresponded to the Cough Peak&#xD;
      Expiratory Flow. Patients' surgical trauma was supported by holding a pillow on the incision&#xD;
      during cough attempts, whereas there was no visual contact with PFM.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      The first part of the study was to investigate the most appropriate command for exhalation&#xD;
      through a straw of a certain inner diameter (5mm) and carried out by using a device consisted&#xD;
      of a drinking straw, a disposable mouthpiece and a manometer to quantify the developed&#xD;
      pressures during the exhalation attempts. The sample of this part included all the&#xD;
      volunteers. Patients did not have visual contact with the manometer. The effectiveness of&#xD;
      each command (Command A: &quot;please blow continuously so that you feel low resistance during&#xD;
      exhalation&quot; and Command B: &quot;please blow continuously so that you feel moderate resistance&#xD;
      during exhalation&quot;) was estimated by comparing the average of the developing pressures during&#xD;
      exhalation attempts arose by the corresponding command with the therapeutic range of pressure&#xD;
      (10-20 cmH2O). This part of the study was a cross-sectional transition and every volunteer&#xD;
      performed 3 attempts for each command. The outputs of the above attempts were recorded but&#xD;
      only the ones of the 3rd attempt were used to the study.&#xD;
&#xD;
      The second part of the study was conducted to evaluate the benefits arising from the use of a&#xD;
      drinking straw as an alternative PEP device. A number of n = 8 volunteers (intervention&#xD;
      group) was selected from the total sample, using the closed envelope method. The remaining&#xD;
      volunteers (n = 5) consisted the control group. Taking into account the results of the first&#xD;
      part of the study, intervention group was requested to exhale as indicated by the &quot;right&quot;&#xD;
      command, performing 3 sets of 10 repetitions, included short breaks between sets.&#xD;
&#xD;
      After the intervention phase, all patients were re-examined to measure the Cough Peak&#xD;
      Expiratory Flow, dyspnea, pain, saturation, heart and respiratory rate, systolic and&#xD;
      diastolic blood pressure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2020</start_date>
  <completion_date type="Actual">March 8, 2020</completion_date>
  <primary_completion_date type="Actual">March 8, 2020</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>Sequential Assignment</intervention_model>
    <intervention_model_description>The first part of the study was carried out by using a device consisted of a drinking straw of an inner diameter of 5mm, a disposable mouthpiece and a manometer.The sample of this part included all the volunteers.The effectiveness of each command (A:&quot;please blow continuously so that you feel low resistance during exhalation&quot; and B:&quot;please blow continuously so that you feel moderate resistance during exhalation&quot;) was estimated by comparing the average of the developing pressures during exhalation attempts arose by the corresponding command with the therapeutic range of pressure.Every volunteer performed 3 attempts for each command.The outputs of the 3rd attempt were used to the study.For the second part of the study, a number of n=8 volunteers (intervention group) was selected from the total sample and was requested to exhale as indicated by the &quot;right&quot; command, for 3 sets of 10 repetitions, included short breaks between sets.The remaining volunteers (n=5) consisted the control group.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison by Commands A and B</measure>
    <time_frame>15 minutes</time_frame>
    <description>Comparison of the outcoming pressures by Commands A and B</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Thoracic Surgery</condition>
  <arm_group>
    <arm_group_label>Patients following Command A and B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group of patients followed the Commands A and B with this specific order, and performed 3 exhalation attempts for each command.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients following Command B and A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group of patients followed the Commands B and A with this specific order, and performed 3 exhalation attempts for each command.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention group was requested to exhale as indicated by the &quot;right&quot; command, performing 3 sets of 10 repetitions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Did not perform exhalation attempts by the &quot;right&quot; command.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pressure measurement during exhalation through a device consisted of a drinking straw of an inner diameter of 5mm, a disposable mouthpiece and a manometer</intervention_name>
    <description>Participants performed exhalation attempts through a device consisted of a drinking straw of an inner diameter of 5mm, a disposable mouthpiece and a manometer, following the instructions of Command A and B (A:&quot;please blow continuously so that you feel low resistance during exhalation&quot; and B:&quot;please blow continuously so that you feel moderate resistance during exhalation&quot;) in a specific order for each group. Every volunteer performed 3 attempts for each command.The outputs of the 3rd attempt were used to the study.</description>
    <arm_group_label>Patients following Command A and B</arm_group_label>
    <arm_group_label>Patients following Command B and A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pressure measurement during exhalation through an alternative PEP device/soft drink straw.</intervention_name>
    <description>Participants were requested to exhale as indicated by the &quot;right&quot; command (Command A or B), for 3 sets of 10 repetitions. This procedure included short breaks between sets.</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients undergone thoracic surgery&#xD;
&#xD;
          -  no limit of age&#xD;
&#xD;
          -  mesosternal or lateral incision&#xD;
&#xD;
          -  hemodynamically stable&#xD;
&#xD;
          -  supplied with an O2 mixture of below 50%&#xD;
&#xD;
          -  full-conscious&#xD;
&#xD;
          -  systolic pressure below 150 cmH20&#xD;
&#xD;
          -  2nd and 3rd postoperative day.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of chronic respiratory disease with severe symptoms&#xD;
&#xD;
          -  tendency to vomit&#xD;
&#xD;
          -  cardiac arrhythmia due to atrial fibrillation postoperatively&#xD;
&#xD;
          -  angina&#xD;
&#xD;
          -  decrease in saturation ≤90&#xD;
&#xD;
          -  dizziness&#xD;
&#xD;
          -  fainting&#xD;
&#xD;
          -  palpitations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kostantinos Grigoriadis, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Attikon Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Garyfallia Pepera, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>University of Thessaly</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dimitrios Dougenis, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>National and Kapodistrian University of Athens</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Attikon Hospital</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Zhang XY, Wang Q, Zhang S, Tan W, Wang Z, Li J. The use of a modified, oscillating positive expiratory pressure device reduced fever and length of hospital stay in patients after thoracic and upper abdominal surgery: a randomised trial. J Physiother. 2015 Jan;61(1):16-20. doi: 10.1016/j.jphys.2014.11.013. Epub 2014 Dec 19.</citation>
    <PMID>25534580</PMID>
  </reference>
  <reference>
    <citation>Urell C, Emtner M, Hedenstrom H, Tenling A, Breidenskog M, Westerdahl E. Deep breathing exercises with positive expiratory pressure at a higher rate improve oxygenation in the early period after cardiac surgery--a randomised controlled trial. Eur J Cardiothorac Surg. 2011 Jul;40(1):162-7. doi: 10.1016/j.ejcts.2010.10.018. Epub 2010 Dec 10.</citation>
    <PMID>21146420</PMID>
  </reference>
  <reference>
    <citation>Orman J, Westerdahl E. Chest physiotherapy with positive expiratory pressure breathing after abdominal and thoracic surgery: a systematic review. Acta Anaesthesiol Scand. 2010 Mar;54(3):261-7. doi: 10.1111/j.1399-6576.2009.02143.x. Epub 2009 Oct 29.</citation>
    <PMID>19878100</PMID>
  </reference>
  <reference>
    <citation>Sehlin M, Ohberg F, Johansson G, Winso O. Physiological responses to positive expiratory pressure breathing: a comparison of the PEP bottle and the PEP mask. Respir Care. 2007 Aug;52(8):1000-5.</citation>
    <PMID>17650355</PMID>
  </reference>
  <reference>
    <citation>Dagan Y, Wiser I, Weissman O, Farber N, Hundeshagen G, Winkler E, Kazula-Halabi T, Haik J. An Improvised &quot;Blow Glove&quot; Device Produces Similar PEP Values to a Commercial PEP Device: An Experimental Study. Physiother Can. 2014 Summer;66(3):308-12. doi: 10.3138/ptc.2013-31.</citation>
    <PMID>25125786</PMID>
  </reference>
  <reference>
    <citation>Banner AS. Cough: physiology, evaluation, and treatment. Lung. 1986;164(2):79-92. doi: 10.1007/BF02713631. No abstract available.</citation>
    <PMID>3084882</PMID>
  </reference>
  <reference>
    <citation>Johnson D, Hurst T, Thomson D, Mycyk T, Burbridge B, To T, Mayers I. Respiratory function after cardiac surgery. J Cardiothorac Vasc Anesth. 1996 Aug;10(5):571-7. doi: 10.1016/s1053-0770(96)80130-3.</citation>
    <PMID>8841860</PMID>
  </reference>
  <reference>
    <citation>Kulnik ST, MacBean V, Birring SS, Moxham J, Rafferty GF, Kalra L. Accuracy of portable devices in measuring peak cough flow. Physiol Meas. 2015 Feb;36(2):243-57. doi: 10.1088/0967-3334/36/2/243. Epub 2015 Jan 13.</citation>
    <PMID>25582526</PMID>
  </reference>
  <reference>
    <citation>Rose L, McKim D, Leasa D, Nonoyama M, Tandon A, Kaminska M, O'Connell C, Loewen A, Connolly B, Murphy P, Hart N, Road J. Monitoring Cough Effectiveness and Use of Airway Clearance Strategies: A Canadian and UK Survey. Respir Care. 2018 Dec;63(12):1506-1513. doi: 10.4187/respcare.06321. Epub 2018 Sep 11.</citation>
    <PMID>30206128</PMID>
  </reference>
  <reference>
    <citation>Winck JC, LeBlanc C, Soto JL, Plano F. The value of cough peak flow measurements in the assessment of extubation or decannulation readiness. Rev Port Pneumol (2006). 2015 Mar-Apr;21(2):94-8. doi: 10.1016/j.rppnen.2014.12.002. Epub 2015 Feb 14.</citation>
    <PMID>25926373</PMID>
  </reference>
  <reference>
    <citation>Ahmad AM. Essentials of Physiotherapy after Thoracic Surgery: What Physiotherapists Need to Know. A Narrative Review. Korean J Thorac Cardiovasc Surg. 2018 Oct;51(5):293-307. doi: 10.5090/kjtcs.2018.51.5.293. Epub 2018 Oct 5.</citation>
    <PMID>30402388</PMID>
  </reference>
  <reference>
    <citation>Holdgate A, Asha S, Craig J, Thompson J. Comparison of a verbal numeric rating scale with the visual analogue scale for the measurement of acute pain. Emerg Med (Fremantle). 2003 Oct-Dec;15(5-6):441-6. doi: 10.1046/j.1442-2026.2003.00499.x.</citation>
    <PMID>14992058</PMID>
  </reference>
  <reference>
    <citation>Fiore JF Jr, Chiavegato LD, Denehy L, Paisani DM, Faresin SM. Do directed cough maneuvers improve cough effectiveness in the early period after open heart surgery? Effect of thoracic support and maximal inspiration on cough peak expiratory flow, cough expiratory volume, and thoracic pain. Respir Care. 2008 Aug;53(8):1027-34.</citation>
    <PMID>18655740</PMID>
  </reference>
  <reference>
    <citation>Hristara-Papadopoulou A, Tsanakas J, Diomou G, Papadopoulou O. Current devices of respiratory physiotherapy. Hippokratia. 2008;12(4):211-20.</citation>
    <PMID>19158964</PMID>
  </reference>
  <reference>
    <citation>Liverani B, Nava S, Polastri M. An integrative review on the positive expiratory pressure (PEP)-bottle therapy for patients with pulmonary diseases. Physiother Res Int. 2020 Jan;25(1):e1823. doi: 10.1002/pri.1823. Epub 2019 Nov 25.</citation>
    <PMID>31762162</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Thessaly</investigator_affiliation>
    <investigator_full_name>Anna Grigoriadou</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Soft drink straw</keyword>
  <keyword>Alternative PEP device</keyword>
  <keyword>Patients undergone thoracic surgery</keyword>
  <keyword>Cough</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04447586
org study id: 101ΣΕ2/16-01-2020
secondary id: 725/25/11/2019
nct id: NCT04447586
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Is there any possibility that patients who undergone thoracic surgery could use a simple soft
      drink straw as an alternative PEP device? The present study was performed to test the
      suitability and effect of a soft drink straw as an alternative Positive Expiratory Pressure
      device in patients undergone thoracic surgery and includes two sub-exploratory areas.

      Before and after the measurements, the volunteers' saturation, heart rate, respiratory rate,
      systolic and diastolic blood pressure, dyspnea, thoracotomy pain and Cough Peak Expiratory
      Flow was measured.

      The first part of the research, that refers to the most appropriate command for exhalation
      from a straw of a certain inner diameter (5mm), was carried out by using a device consisted
      of drinking straw, disposable mouthpiece and manometer, which valued the developed pressures
      during the exhalation attempts. Patients did not have visual contact with the manometer. The
      effectiveness of two commands (Command A: "blow continuously so that you feel little
      resistance during exhalation" and Command B: "blow continuously so that you feel moderate
      resistance during exhalation") was estimated by comparing the average of the developing
      pressures for every command, that occur during exhalation, with the therapeutic range of
      pressure. This part of the study was a cross-sectional transition and every volunteer
      performed 3 attempts, for each command.

      The second part of the research was conducted for the evaluation of the benefits of the use
      of a drinking straw as an alternative device. A number of n = 8 volunteers (intervention
      group), who were selected from the overall sample using the closed envelope method. Taking
      into account the results of the first part of the research, the respondents were asked to
      exhale as indicated by the command that was selected before, performing 3 sets of 10
      repetitions, that included short breaks between sets. The remaining volunteers (n = 5)
      consisted the control group.

      Finally, all patients were re-examined in order to measure the Cough Peak Expiratory Flow ,
      dyspnea, pain, saturation, heart and respiratory rate, and systolic and diastolic blood
      pressure, after the intervention.
INTRODUCTION

      The use of positive expiratory pressure devices is considered beneficial in patients who have
      undergone abdominal and thoracic surgery with an impact on blood gas measurement values, the
      hospitalization length, the use of antibiotics and the pathology of the chest. Of course,
      there are researchers who doubt the effectiveness of the method, mainly due to the fact that
      it does not possibly reduce the risk of atelectasis, especially in patients who undergone
      cardiac surgery. However, the method is very popular in physiotherapy, and the use of
      alternative devices that create positive expiratory pressure, such as water bottles or
      gloves, is suggested, especially in cases when the access to the classic devices is not easy,
      mainly during the periods of crisis.

      Coughing is a process that ensures the cleaning and protection of the airways. The outcome of
      the thoracic surgery may often depend on the quality of the patient's cough postoperatively
      which may put the patient at risk that could last for up to eight weeks. The effectiveness of
      the cough can be assessed by measuring the peak cough flow using a peak flow meter, method
      that many researchers in Europe and America prefer. Cough with a maximum expiratory flow over
      160 L/min could ensure a safe extubation or decannulation of severely ill and postoperative
      patients. Therefore, if there was a way leading to cough enhancement, this could be a
      lifeline to the recovery of these type of patients.

      PURPOSE

      The present study was performed to test the suitability and effect of a soft drink straw as
      an alternative positive expiratory pressure device in patients undergone thoracic surgery and
      includes two sub-exploratory areas.

      In the first one, it was investigated the most appropriate command of exhalation into a
      specific internal diameter straw, whereas on the other hand, it was examined the improvement
      of patient's overview by using the particular alternative device.

      RESEARCH HYPOTHESIS

      Is there any possibility of a simple soft drink straw being an alternative PEP device which
      could improve the cough flow of patients who undergone thoracic surgery?

      METHODOLOGY

      The research was approved by "ATTIKON" University General Hospital (with reference number
      725/25/11/2019) and by the University of Thessaly (with reference number 101SE2/16-01-2020).

      The study was performed at the Cardiac Surgery Clinic of "ATTIKON" University General
      Hospital and participated all the adult thoracic surgical patients, with no limit of age,
      from 12-02-2020 to 08-03-2020 Patients beforehand, are informed with the purpose of the study
      and necessarily sign the Patient Consensus Form for their participation in the study.

      Sample:

      The sample of present study included all adult patients that undergone thoracic surgery, with
      no limit of age, with a mesosternal or lateral incision, who considered hemodynamically
      stable, were supplied with an O2 mixture of below 50%, full-conscious, with systolic pressure
      below 150 cmH20. The records were carried out on the 2nd and 3rd postoperative day.

      Patients with history of chronic respiratory disease, with severe symptoms, tendency to
      vomit, cardiac arrhythmia due to atrial fibrillation postoperatively, and patients with
      angina were excluded from the study. The records were carried out in the morning or at noon
      and were automatically stopped if patient had any difficulty, decrease in saturation ≤90,
      feeling of dizziness, fainting and palpitations. The number of volunteers excluded from the
      study was n = 4 (2 people due to dizziness during the sitting position, 1 person with a
      tendency to vomit before the beginning of the process and 1 person due to re-intubation
      before the beginning of the process).

      Procedure:

      All patients were beforehand informed about the purpose of the study and signed the Patient
      Consensus Form in order to participate the study. Data, such as age, height and weight, type
      of surgery and concomitant pathologies, if any, were collected. Patients' medical records
      were examined to verify the collected information and find any indication that could have led
      to their exclusion from the study. Records and measurements were begun only after
      consultation with patient's doctor.

      Each participant was placed in a sitting position, with his popliteal region of the knees
      near the edge of the bed and stayed in this position for at least 2 minutes in order to be
      checked that he won't develop any symptom such as discoloration of the face's skin, dizziness
      or fainting. In case of appearance of any of the above symptoms, patient was placed back in a
      supine position and the procedure stopped. Patients who felt a very light dizziness detected
      by overview or oral evaluation, remained seated until the symptom passes and then records and
      measurements were started. If the symptom continued, the procedure was stopped and patient
      returned to the supine position.

      In the first phase of the study, all volunteers' saturation and heart rate was recorded using
      oximeter or monitor's indications, whereas the recording of respiratory rate followed by
      placing one researcher's hands on the subject's epigastrium. Both systolic and diastolic
      blood pressure were recorded with an analog pressure gauge, as well dyspnea (calibrated using
      the borg scale) and thoracotomy pain, which was quantified using the numerical pain scale
      (Numeric Rating Scale - oral application).

      The maximum expiratory flow of air during coughing was estimated with a Peak Flow Meter (PFM)
      device. Participants applied their lips to a disposable mouthpiece, which was connected to
      the PFM and followed the command "please cough hard inside the device". The value recorded
      through the PFM device, which was the airflow during coughing, corresponded to the Cough Peak
      Expiratory Flow. Patients' surgical trauma was supported by holding a pillow on the incision
      during cough attempts, whereas there was no visual contact with PFM.

      Intervention:

      The first part of the study was to investigate the most appropriate command for exhalation
      through a straw of a certain inner diameter (5mm) and carried out by using a device consisted
      of a drinking straw, a disposable mouthpiece and a manometer to quantify the developed
      pressures during the exhalation attempts. The sample of this part included all the
      volunteers. Patients did not have visual contact with the manometer. The effectiveness of
      each command (Command A: "please blow continuously so that you feel low resistance during
      exhalation" and Command B: "please blow continuously so that you feel moderate resistance
      during exhalation") was estimated by comparing the average of the developing pressures during
      exhalation attempts arose by the corresponding command with the therapeutic range of pressure
      (10-20 cmH2O). This part of the study was a cross-sectional transition and every volunteer
      performed 3 attempts for each command. The outputs of the above attempts were recorded but
      only the ones of the 3rd attempt were used to the study.

      The second part of the study was conducted to evaluate the benefits arising from the use of a
      drinking straw as an alternative PEP device. A number of n = 8 volunteers (intervention
      group) was selected from the total sample, using the closed envelope method. The remaining
      volunteers (n = 5) consisted the control group. Taking into account the results of the first
      part of the study, intervention group was requested to exhale as indicated by the "right"
      command, performing 3 sets of 10 repetitions, included short breaks between sets.

      After the intervention phase, all patients were re-examined to measure the Cough Peak
      Expiratory Flow, dyspnea, pain, saturation, heart and respiratory rate, systolic and
      diastolic blood pressure.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: The first part of the study was carried out by using a device consisted of a drinking straw of an inner diameter of 5mm, a disposable mouthpiece and a manometer.The sample of this part included all the volunteers.The effectiveness of each command (A:"please blow continuously so that you feel low resistance during exhalation" and B:"please blow continuously so that you feel moderate resistance during exhalation") was estimated by comparing the average of the developing pressures during exhalation attempts arose by the corresponding command with the therapeutic range of pressure.Every volunteer performed 3 attempts for each command.The outputs of the 3rd attempt were used to the study.For the second part of the study, a number of n=8 volunteers (intervention group) was selected from the total sample and was requested to exhale as indicated by the "right" command, for 3 sets of 10 repetitions, included short breaks between sets.The remaining volunteers (n=5) consisted the control group.
primary purpose: Other
masking: Single (Participant)
measure: Comparison by Commands A and B
time frame: 15 minutes
description: Comparison of the outcoming pressures by Commands A and B
arm group label: Patients following Command A and B
arm group type: Active Comparator
description: This group of patients followed the Commands A and B with this specific order, and performed 3 exhalation attempts for each command.
arm group label: Patients following Command B and A
arm group type: Active Comparator
description: This group of patients followed the Commands B and A with this specific order, and performed 3 exhalation attempts for each command.
arm group label: intervention group
arm group type: Active Comparator
description: Intervention group was requested to exhale as indicated by the "right" command, performing 3 sets of 10 repetitions.
arm group label: control group
arm group type: No Intervention
description: Did not perform exhalation attempts by the "right" command.
intervention type: Other
intervention name: Pressure measurement during exhalation through a device consisted of a drinking straw of an inner diameter of 5mm, a disposable mouthpiece and a manometer
description: Participants performed exhalation attempts through a device consisted of a drinking straw of an inner diameter of 5mm, a disposable mouthpiece and a manometer, following the instructions of Command A and B (A:"please blow continuously so that you feel low resistance during exhalation" and B:"please blow continuously so that you feel moderate resistance during exhalation") in a specific order for each group. Every volunteer performed 3 attempts for each command.The outputs of the 3rd attempt were used to the study.
arm group label: Patients following Command A and B
arm group label: Patients following Command B and A
intervention type: Other
intervention name: Pressure measurement during exhalation through an alternative PEP device/soft drink straw.
description: Participants were requested to exhale as indicated by the "right" command (Command A or B), for 3 sets of 10 repetitions. This procedure included short breaks between sets.
arm group label: intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kostantinos Grigoriadis, Dr
role: Study Director
affiliation: Attikon Hospital
last name: Garyfallia Pepera, Dr
role: Study Chair
affiliation: University of Thessaly
last name: Dimitrios Dougenis, Prof
role: Study Chair
affiliation: National and Kapodistrian University of Athens
facility: 
country: Greece
citation: Zhang XY, Wang Q, Zhang S, Tan W, Wang Z, Li J. The use of a modified, oscillating positive expiratory pressure device reduced fever and length of hospital stay in patients after thoracic and upper abdominal surgery: a randomised trial. J Physiother. 2015 Jan;61(1):16-20. doi: 10.1016/j.jphys.2014.11.013. Epub 2014 Dec 19.
PMID: 25534580
citation: Urell C, Emtner M, Hedenstrom H, Tenling A, Breidenskog M, Westerdahl E. Deep breathing exercises with positive expiratory pressure at a higher rate improve oxygenation in the early period after cardiac surgery--a randomised controlled trial. Eur J Cardiothorac Surg. 2011 Jul;40(1):162-7. doi: 10.1016/j.ejcts.2010.10.018. Epub 2010 Dec 10.
PMID: 21146420
citation: Orman J, Westerdahl E. Chest physiotherapy with positive expiratory pressure breathing after abdominal and thoracic surgery: a systematic review. Acta Anaesthesiol Scand. 2010 Mar;54(3):261-7. doi: 10.1111/j.1399-6576.2009.02143.x. Epub 2009 Oct 29.
PMID: 19878100
citation: Sehlin M, Ohberg F, Johansson G, Winso O. Physiological responses to positive expiratory pressure breathing: a comparison of the PEP bottle and the PEP mask. Respir Care. 2007 Aug;52(8):1000-5.
PMID: 17650355
citation: Dagan Y, Wiser I, Weissman O, Farber N, Hundeshagen G, Winkler E, Kazula-Halabi T, Haik J. An Improvised "Blow Glove" Device Produces Similar PEP Values to a Commercial PEP Device: An Experimental Study. Physiother Can. 2014 Summer;66(3):308-12. doi: 10.3138/ptc.2013-31.
PMID: 25125786
citation: Banner AS. Cough: physiology, evaluation, and treatment. Lung. 1986;164(2):79-92. doi: 10.1007/BF02713631. No abstract available.
PMID: 3084882
citation: Johnson D, Hurst T, Thomson D, Mycyk T, Burbridge B, To T, Mayers I. Respiratory function after cardiac surgery. J Cardiothorac Vasc Anesth. 1996 Aug;10(5):571-7. doi: 10.1016/s1053-0770(96)80130-3.
PMID: 8841860
citation: Kulnik ST, MacBean V, Birring SS, Moxham J, Rafferty GF, Kalra L. Accuracy of portable devices in measuring peak cough flow. Physiol Meas. 2015 Feb;36(2):243-57. doi: 10.1088/0967-3334/36/2/243. Epub 2015 Jan 13.
PMID: 25582526
citation: Rose L, McKim D, Leasa D, Nonoyama M, Tandon A, Kaminska M, O'Connell C, Loewen A, Connolly B, Murphy P, Hart N, Road J. Monitoring Cough Effectiveness and Use of Airway Clearance Strategies: A Canadian and UK Survey. Respir Care. 2018 Dec;63(12):1506-1513. doi: 10.4187/respcare.06321. Epub 2018 Sep 11.
PMID: 30206128
citation: Winck JC, LeBlanc C, Soto JL, Plano F. The value of cough peak flow measurements in the assessment of extubation or decannulation readiness. Rev Port Pneumol (2006). 2015 Mar-Apr;21(2):94-8. doi: 10.1016/j.rppnen.2014.12.002. Epub 2015 Feb 14.
PMID: 25926373
citation: Ahmad AM. Essentials of Physiotherapy after Thoracic Surgery: What Physiotherapists Need to Know. A Narrative Review. Korean J Thorac Cardiovasc Surg. 2018 Oct;51(5):293-307. doi: 10.5090/kjtcs.2018.51.5.293. Epub 2018 Oct 5.
PMID: 30402388
citation: Holdgate A, Asha S, Craig J, Thompson J. Comparison of a verbal numeric rating scale with the visual analogue scale for the measurement of acute pain. Emerg Med (Fremantle). 2003 Oct-Dec;15(5-6):441-6. doi: 10.1046/j.1442-2026.2003.00499.x.
PMID: 14992058
citation: Fiore JF Jr, Chiavegato LD, Denehy L, Paisani DM, Faresin SM. Do directed cough maneuvers improve cough effectiveness in the early period after open heart surgery? Effect of thoracic support and maximal inspiration on cough peak expiratory flow, cough expiratory volume, and thoracic pain. Respir Care. 2008 Aug;53(8):1027-34.
PMID: 18655740
citation: Hristara-Papadopoulou A, Tsanakas J, Diomou G, Papadopoulou O. Current devices of respiratory physiotherapy. Hippokratia. 2008;12(4):211-20.
PMID: 19158964
citation: Liverani B, Nava S, Polastri M. An integrative review on the positive expiratory pressure (PEP)-bottle therapy for patients with pulmonary diseases. Physiother Res Int. 2020 Jan;25(1):e1823. doi: 10.1002/pri.1823. Epub 2019 Nov 25.
PMID: 31762162
responsible party type: Principal Investigator
investigator affiliation: University of Thessaly
investigator full name: Anna Grigoriadou
investigator title: Physiotherapist
mesh term: Aortic Dissection
sharing ipd: No