Effect of Cuff Pressure of Endotracheal Tube on POST

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

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Surgery; Tracheal Intubation Morbidity; Sore-throat

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 Type: Observational
• Enrollment (Actual): 337

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Hyun-Kyu Yoon
  • Please Select An Option
    • Seoul, Please Select An Option, South Korea, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing laparoscopic surgery and endotracheal intubation under general anesthesia

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative sore throat 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)	at 24h postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative sore throat 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)	at 1h postoperatively
Incidence of postoperative sore throat 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)	at 48h postoperatively
Incidence of postoperative hoarseness 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)	at 1h postoperatively
Incidence of postoperative hoarseness 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)	at 24h postoperatively.
Incidence of postoperative hoarseness 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)	at 48h postoperatively

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2022
• Primary Completion (Actual): August 7, 2025
• Study Completion (Actual): August 10, 2025

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Endotracheal intubation; Cuff pressure; Sore throat; Hoarseness
• Additional Relevant MeSH Terms: Neurologic Manifestations; Stomatognathic Diseases; Nervous System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Pharyngeal Diseases; Laryngeal Diseases; Voice Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hoarseness; Pharyngitis
• Other Study ID Numbers: POST_cuff_pressure

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No