Effect of Cuff Pressure of Endotracheal Tube on POST

Laparoscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05542823
• Other study ID #: POST_cuff_pressure
• Status: Recruiting
• Start date: October 4, 2022
• Est. completion date: December 14, 2024

Study information

• Verified date: December 2023
• Source: Seoul National University Hospital
• Contact: Hyun-Kyu Yoon, MD
• Phone: +82-2-2072-0065
• Email: hyunkyu18[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 337
• Est. completion date: December 14, 2024
• Est. primary completion date: October 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Surgery
• Pharyngitis
• Tracheal Intubation Morbidity

Locations

Country	Name	City	State
Korea, Republic of	Hyun-Kyu Yoon	Seoul
Korea, Republic of	Seoul national university hospital	Seoul	Please Select An Option

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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