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Completed

NCT Number: NCT05542823

Effect of Cuff Pressure of Endotracheal Tube on POST

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.

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Key information

Conditions

Laparoscopic Surgery Hoarseness Infections Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Sore-throat Stomatognathic Diseases Tracheal Intubation Morbidity Voice Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul national university hospital, Seoul, Please Select An Option, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of Cuff Pressure of Endotracheal Tube on Postoperative Sore Throat: a Prospective Observational Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2022
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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