Effect of Cuff Pressure of Endotracheal Tube on POST

Recruiting

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

• Registration Number: NCT05542823
• Lead Sponsor: Seoul National University Hospital

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.

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 Timeline

• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-16
• Study Start: 2022-10-04
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-14
• Primary Completion: 2024-10-14
• Study Completion: 2024-12-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 337

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative sore throat at 24h postoperatively.	at 24h postoperatively.	Incidence of postoperative sore throat (score 1 or more) 0 = no sore throat; 1. = mild sore throat (less severe 1 = mild sore throat (less severe than with a cold); 2. = moderate sore throat (as with a cold)2 = moderate sore throat (as with a cold); 3. = severe (more severe than with a cold)3 = severe (more severe than with a cold)

Secondary Outcome Measures

Name	Time	Method
Incidence of postoperative hoarseness at 1h postoperatively.	at 1h postoperatively	Incidence of postoperative hoarseness (score 1 or more) 0 = no hoarseness; 1. = mild hoarseness (noticed by the patient only); 2. = severe hoarseness (noticed by the time of the interview by the personnel); 3. = aphonia (inability to speak)
Incidence of postoperative hoarseness at 48h postoperatively.	at 48h postoperatively	Incidence of postoperative hoarseness (score 1 or more) 0 = no hoarseness; 1. = mild hoarseness (noticed by the patient only); 2. = severe hoarseness (noticed by the time of the interview by the personnel); 3. = aphonia (inability to speak)
Incidence of postoperative hoarseness at 24h postoperatively.	at 24h postoperatively.	Incidence of postoperative hoarseness (score 1 or more) 0 = no hoarseness; 1. = mild hoarseness (noticed by the patient only); 2. = severe hoarseness (noticed by the time of the interview by the personnel); 3. = aphonia (inability to speak)
Incidence of postoperative sore throat at 1h postoperatively.	at 1h postoperatively	Incidence of postoperative sore throat (score 1 or more) 0 = no sore throat; 1. = mild sore throat (less severe 1 = mild sore throat (less severe than with a cold); 2. = moderate sore throat (as with a cold)2 = moderate sore throat (as with a cold); 3. = severe (more severe than with a cold)3 = severe (more severe than with a cold)
Incidence of postoperative sore throat at 48h postoperatively.	at 48h postoperatively	Incidence of postoperative sore throat (score 1 or more) 0 = no sore throat; 1. = mild sore throat (less severe 1 = mild sore throat (less severe than with a cold); 2. = moderate sore throat (as with a cold)2 = moderate sore throat (as with a cold); 3. = severe (more severe than with a cold)3 = severe (more severe than with a cold)

Trial Locations

Locations (2)

Hyun-Kyu Yoon; 🇰🇷 Seoul, Korea, Republic of

Seoul national university hospital; 🇰🇷 Seoul, Please Select An Option, Korea, Republic of