<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/NCT04466995</url>
  </required_header>
  <id_info>
    <org_study_id>2020/92</org_study_id>
    <nct_id>NCT04466995</nct_id>
  </id_info>
  <brief_title>Factors Affecting Endotracheal Cuff Pressure in Gynecological Cases</brief_title>
  <official_title>Factors Affecting Endotracheal Cuff Pressure in Laparoscopic and Laparotomic Gynecological Cases and Its Effect on Postoperative Respiratory Complications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative airway complications associated with endotracheal intubation can be seen.&#xD;
&#xD;
      While some of these complications are predictable, some may occur urgently. If the&#xD;
      endotracheal cuff is over-inflated and its pressure is high, mucosal damage resulting from&#xD;
      mucosal pressure is one of the main factors for tracheal morbidity. Endotracheal tube cuff&#xD;
      pressure is not routinely measured. It was confirmed that the palpation of the pilot balloon&#xD;
      was insufficient to detect high cuff pressures. In laparoscopic cases, the investigators&#xD;
      aimed to investigate whether the increase in intra-abdominal pressure as a result of carbon&#xD;
      dioxide insufflation, and the change of respiratory functions after trendelenburg position&#xD;
      are effective on cuff pressure and whether there is a difference compared to laparotomic&#xD;
      cases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It was planned to include 50 patients in the American Anesthesiologists Association (ASA) 1-3&#xD;
      risk score group, which will be an elective gynecological operation between the ages of&#xD;
      18-70. When patients arrive in the operating room, after the ECG, pulse oximeter,&#xD;
      non-invasive pressure monitoring is provided in the supine position, 18 gauge intravenous(iv)&#xD;
      vascular access will be opened and balanced fluid 4-6 ml / kg / h will be inserted.&#xD;
      Anesthesia induction with midazolam 0.05 mg / kg, propofol 2-3 mg / kg, Fentanyl 1-2 µg / kg&#xD;
      and rocuronium 0.6 mg / kg will be achieved after 3 minutes of preoxygenation. he muscle&#xD;
      relaxant effect will be monitored by monitoring TOF (train of four), and after sufficient&#xD;
      relaxation (TOF 95%), the anesthetist will be intubated with the 7-7.5 number endotracheal&#xD;
      tube suitable for the high-volume low-pressure patient. The cuff of the endotracheal tube&#xD;
      will be inflated with the help of an injector and the cuff will be attached to the manometer.&#xD;
      Cuff pressures will be inflated to 25 mmHg. The patients will be given oxygen at 40% and air&#xD;
      at 3lt / min. The maintenance of anesthesia will be achieved with sevoflurane and 0.05-0.1mcg&#xD;
      / kg / min remifentanil infusion.&#xD;
&#xD;
      If the patient feels pain in the perioperative period, 50 mcg fentanyl iv will be used as&#xD;
      rescue analgesia. During the operation, rokurunium (0.2mg / kg) boluses will be delivered&#xD;
      according to the patient's clinic and the TOF value between 0-2 (depending on the type of&#xD;
      surgery). Mechanical ventilation will be started in volume controlled mode with 6-8 ml / kg&#xD;
      tidal volume, and 12 frequencies. Respiratory frequencies,tidal volume and positive end&#xD;
      expiratory pressure (PEEP) values of patients will be optimized so that end tidal CO2 is&#xD;
      35-45 mmHg throughout the case. At the end of surgery, 100 mg tramadol and 1 g paracetamol&#xD;
      will be administered to patients for the purpose of postoperative analgesia. Patients will be&#xD;
      extubated after the muscle relaxant is recurrentized with 0.03mg / kg neostigmine and 0.01mg&#xD;
      / kg atropine.&#xD;
&#xD;
      If the patient's numeric rating scale (NRS) score is 3 or more during recovery, 0.3 mg / kg&#xD;
      Petidine hydrochloride will be applied as rescue analgesia. The 'Case Tracking Form' prepared&#xD;
      for the follow-up of the research will be recorded demographically, age, height, weight and&#xD;
      BMI information of the patients in the preoperative period.&#xD;
&#xD;
      In the perioperative period, cuff pressures in the supine position after intubation, at the&#xD;
      5th, 15th, 30th, 45th minutes and before extubation will be measured and recorded with the&#xD;
      cuff manometer. In addition to the follow-up form, intra-abdominal pressure, PEEP, P peak and&#xD;
      P plateau values, anesthesia time, operation time during each measurement will be recorded.&#xD;
      Patients who were followed-up in the recovery were evaluated by the service nurse who did not&#xD;
      know how to work in the service at the postoperative 1st, 12th, 24th hours, and the NRS&#xD;
      (numeric rating scale) (0 is painless, 10 is the most painful and will be asked to describe&#xD;
      the pain from 1 to 10); It will be evaluated in terms of dysphagia, cough, sore throat,&#xD;
      hoarseness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2020</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">January 1, 2021</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Endotracheal tube pressure will be measured in the surgical technique using 2 different methods.(laparoscopic and laprotomic)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cuff pressure</measure>
    <time_frame>1 hour</time_frame>
    <description>cuff pressure to be measured with manometer</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Intubation Complication</condition>
  <arm_group>
    <arm_group_label>laparoscopic gynecologic surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 laparoscopic surgery to endotracheal cuff pressure 5., 15., 30., 45. min will be measured, values will be recorded</description>
  </arm_group>
  <arm_group>
    <arm_group_label>laparotomic gynecologic surgery</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>25 laparotomic surgery to endotracheal cuff pressure 5., 15., 30., 45. min will be measured, values will be recorded</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>manometer</intervention_name>
    <description>cuff pressure to be measured with manometer</description>
    <arm_group_label>laparoscopic gynecologic surgery</arm_group_label>
    <arm_group_label>laparotomic gynecologic surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients between 18-70 years old who will undergo gynecological abdominal&#xD;
             surgery&#xD;
&#xD;
          -  Patients with American Society of Anesthesiologists physical status 1-3&#xD;
&#xD;
          -  Patients who will undergo elective surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with tracheotomy&#xD;
&#xD;
          -  Patients with detected tracheal stenosis&#xD;
&#xD;
          -  Patients with laryngeal disease or laryngeal surgery&#xD;
&#xD;
          -  Patients with difficult airway (intubated after 2 or more attempts)&#xD;
&#xD;
          -  Patients with BMI&gt; 35&#xD;
&#xD;
          -  Patients receiving chronic obstructive pulmonary disease treatment&#xD;
&#xD;
          -  Patients with ASA ≥4&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>gunes o yildiz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bakırkoy Dr. Sadi Konuk Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bakirkoy Dr. Sadi Konuk Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Bakirkoy</state>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>January 31, 2022</last_update_submitted>
  <last_update_submitted_qc>January 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</investigator_affiliation>
    <investigator_full_name>Güneş Özlem Yıldız</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT04466995
org study id: 2020/92
nct id: NCT04466995
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Postoperative airway complications associated with endotracheal intubation can be seen.

      While some of these complications are predictable, some may occur urgently. If the
      endotracheal cuff is over-inflated and its pressure is high, mucosal damage resulting from
      mucosal pressure is one of the main factors for tracheal morbidity. Endotracheal tube cuff
      pressure is not routinely measured. It was confirmed that the palpation of the pilot balloon
      was insufficient to detect high cuff pressures. In laparoscopic cases, the investigators
      aimed to investigate whether the increase in intra-abdominal pressure as a result of carbon
      dioxide insufflation, and the change of respiratory functions after trendelenburg position
      are effective on cuff pressure and whether there is a difference compared to laparotomic
      cases.
It was planned to include 50 patients in the American Anesthesiologists Association (ASA) 1-3
      risk score group, which will be an elective gynecological operation between the ages of
      18-70. When patients arrive in the operating room, after the ECG, pulse oximeter,
      non-invasive pressure monitoring is provided in the supine position, 18 gauge intravenous(iv)
      vascular access will be opened and balanced fluid 4-6 ml / kg / h will be inserted.
      Anesthesia induction with midazolam 0.05 mg / kg, propofol 2-3 mg / kg, Fentanyl 1-2 µg / kg
      and rocuronium 0.6 mg / kg will be achieved after 3 minutes of preoxygenation. he muscle
      relaxant effect will be monitored by monitoring TOF (train of four), and after sufficient
      relaxation (TOF 95%), the anesthetist will be intubated with the 7-7.5 number endotracheal
      tube suitable for the high-volume low-pressure patient. The cuff of the endotracheal tube
      will be inflated with the help of an injector and the cuff will be attached to the manometer.
      Cuff pressures will be inflated to 25 mmHg. The patients will be given oxygen at 40% and air
      at 3lt / min. The maintenance of anesthesia will be achieved with sevoflurane and 0.05-0.1mcg
      / kg / min remifentanil infusion.

      If the patient feels pain in the perioperative period, 50 mcg fentanyl iv will be used as
      rescue analgesia. During the operation, rokurunium (0.2mg / kg) boluses will be delivered
      according to the patient's clinic and the TOF value between 0-2 (depending on the type of
      surgery). Mechanical ventilation will be started in volume controlled mode with 6-8 ml / kg
      tidal volume, and 12 frequencies. Respiratory frequencies,tidal volume and positive end
      expiratory pressure (PEEP) values of patients will be optimized so that end tidal CO2 is
      35-45 mmHg throughout the case. At the end of surgery, 100 mg tramadol and 1 g paracetamol
      will be administered to patients for the purpose of postoperative analgesia. Patients will be
      extubated after the muscle relaxant is recurrentized with 0.03mg / kg neostigmine and 0.01mg
      / kg atropine.

      If the patient's numeric rating scale (NRS) score is 3 or more during recovery, 0.3 mg / kg
      Petidine hydrochloride will be applied as rescue analgesia. The 'Case Tracking Form' prepared
      for the follow-up of the research will be recorded demographically, age, height, weight and
      BMI information of the patients in the preoperative period.

      In the perioperative period, cuff pressures in the supine position after intubation, at the
      5th, 15th, 30th, 45th minutes and before extubation will be measured and recorded with the
      cuff manometer. In addition to the follow-up form, intra-abdominal pressure, PEEP, P peak and
      P plateau values, anesthesia time, operation time during each measurement will be recorded.
      Patients who were followed-up in the recovery were evaluated by the service nurse who did not
      know how to work in the service at the postoperative 1st, 12th, 24th hours, and the NRS
      (numeric rating scale) (0 is painless, 10 is the most painful and will be asked to describe
      the pain from 1 to 10); It will be evaluated in terms of dysphagia, cough, sore throat,
      hoarseness.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Endotracheal tube pressure will be measured in the surgical technique using 2 different methods.(laparoscopic and laprotomic)
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: cuff pressure
time frame: 1 hour
description: cuff pressure to be measured with manometer
arm group label: laparoscopic gynecologic surgery
arm group type: Experimental
description: 25 laparoscopic surgery to endotracheal cuff pressure 5., 15., 30., 45. min will be measured, values will be recorded
arm group label: laparotomic gynecologic surgery
arm group type: Other
description: 25 laparotomic surgery to endotracheal cuff pressure 5., 15., 30., 45. min will be measured, values will be recorded
intervention type: Device
intervention name: manometer
description: cuff pressure to be measured with manometer
arm group label: laparoscopic gynecologic surgery
arm group label: laparotomic gynecologic surgery
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: gunes o yildiz
role: Principal Investigator
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
investigator full name: Güneş Özlem Yıldız
investigator title: Principal Investigator