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Effect of Cuff Pressure of Endotracheal Tube on POST

Sponsor
Seoul National University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05542823
Collaborator
(none)
337
Enrollment
1
Location
12
Anticipated Duration (Months)
28.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of this study is to evaluate the association between the duration of intraoperative cuff overpressure and the development of postoperative sore throat.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    For patients undergoing laparoscopic surgery after tracheal intubation, continuous cuff pressure monitoring is performed by connecting a pressure monitor to the cuff of the endotracheal tube. The incidence of postoperative sore throat was evaluated via direct questioning in all patients. This study aimed to investigate the association between the development of postoperative sore throat and the duration of overpressure in the cuff of the endotracheal tube.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    337 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of Cuff Pressure of Endotracheal Tube on Postoperative Sore Throat: a Prospective Observational Study
    Anticipated Study Start Date :
    Sep 15, 2022
    Anticipated Primary Completion Date :
    Sep 14, 2023
    Anticipated Study Completion Date :
    Sep 14, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of postoperative sore throat at 24h postoperatively. [at 24h postoperatively.]

      Incidence of postoperative sore throat (score 1 or more) 0 = no sore throat = mild sore throat (less severe 1 = mild sore throat (less severe than with a cold) = moderate sore throat (as with a cold)2 = moderate sore throat (as with a cold) = severe (more severe than with a cold)3 = severe (more severe than with a cold)

    Secondary Outcome Measures

    1. Incidence of postoperative sore throat at 1h postoperatively. [at 1h postoperatively]

      Incidence of postoperative sore throat (score 1 or more) 0 = no sore throat = mild sore throat (less severe 1 = mild sore throat (less severe than with a cold) = moderate sore throat (as with a cold)2 = moderate sore throat (as with a cold) = severe (more severe than with a cold)3 = severe (more severe than with a cold)

    2. Incidence of postoperative sore throat at 48h postoperatively. [at 48h postoperatively]

      Incidence of postoperative sore throat (score 1 or more) 0 = no sore throat = mild sore throat (less severe 1 = mild sore throat (less severe than with a cold) = moderate sore throat (as with a cold)2 = moderate sore throat (as with a cold) = severe (more severe than with a cold)3 = severe (more severe than with a cold)

    3. Incidence of postoperative hoarseness at 1h postoperatively. [at 1h postoperatively]

      Incidence of postoperative hoarseness (score 1 or more) 0 = no hoarseness = mild hoarseness (noticed by the patient only) = severe hoarseness (noticed by the time of the interview by the personnel) = aphonia (inability to speak)

    4. Incidence of postoperative hoarseness at 24h postoperatively. [at 24h postoperatively.]

      Incidence of postoperative hoarseness (score 1 or more) 0 = no hoarseness = mild hoarseness (noticed by the patient only) = severe hoarseness (noticed by the time of the interview by the personnel) = aphonia (inability to speak)

    5. Incidence of postoperative hoarseness at 48h postoperatively. [at 48h postoperatively]

      Incidence of postoperative hoarseness (score 1 or more) 0 = no hoarseness = mild hoarseness (noticed by the patient only) = severe hoarseness (noticed by the time of the interview by the personnel) = aphonia (inability to speak)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing laparoscopic surgery and endotracheal intubation under general anesthesia
    Exclusion Criteria:

    • Patients who already had sore throat and hoarseness before surgery

    • Patients who were expected to have anticipated difficult airway

    • Surgery duration < 1 hour

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hyun-Kyu Yoon Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Hyun-Kyu Yoon, Seoul National University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hyun-Kyu Yoon, Clinical assistant professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT05542823
    Other Study ID Numbers:
    • POST_cuff_pressure
    First Posted:
    Sep 16, 2022
    Last Update Posted:
    Sep 16, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hyun-Kyu Yoon, Clinical assistant professor, Seoul National University Hospital
    Laparoscopic surgery
    Endotracheal intubation
    Cuff pressure
    Sore throat
    Hoarseness
    Additional relevant MeSH terms:
    Pharyngitis

    Study Results

    No Results Posted as of Sep 16, 2022