Continuous Endotracheal Tube Cuff Pressure Monitoring and Postoperative Airway Complications in Laparoscopic Surgery

NCT07485972 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2026-03-20

No results posted yet for this study

Summary

This prospective randomized controlled study evaluated the effects of different endotracheal tube cuff pressure monitoring strategies on postoperative airway complications in patients undergoing elective laparoscopic abdominal surgery under general anesthesia. Excessive endotracheal tube cuff pressure may impair tracheal mucosal perfusion and lead to postoperative airway symptoms such as sore throat, cough, dysphagia, hoarseness, and hemoptysis.

A total of 95 adult patients (ASA I-II) aged 18-65 years were randomly assigned to one of three groups according to the cuff pressure monitoring technique used during surgery: the cuff-leak technique (control group), intermittent cuff pressure monitoring using a manual manometer every 30 minutes, or continuous cuff pressure monitoring using a pressure transducer connected to the pilot balloon.

The primary outcome was the incidence of cuff-related postoperative airway complications at postoperative hours 2 and 24. Secondary outcomes included tracheal mucosal injury assessed by fiberoptic bronchoscopy before extubation and its association with postoperative airway symptoms. The study aimed to determine whether continuous cuff pressure monitoring reduces postoperative airway complications and tracheal mucosal injury compared with intermittent monitoring and the cuff-leak technique.

Conditions

  • Postoperative Airway Complications
  • Postoperative Sore Throat
  • Endotracheal Tube Cuff Pressure

Interventions

PROCEDURE

Intermittent cuff pressure monitoring

Endotracheal tube cuff pressure was adjusted to 25 cmH₂O using a manual manometer and rechecked every 30 minutes during surgery. If the pressure was outside the range of 20-30 cmH₂O, it was readjusted accordingly.

PROCEDURE

Continuous cuff pressure monitoring

Endotracheal tube cuff pressure was continuously monitored using a pressure transducer connected to the pilot balloon via a three-way stopcock and maintained at approximately 25 cmH₂O throughout surgery.

PROCEDURE

Cuff-leak technique

The endotracheal tube cuff was inflated using the cuff-leak technique without objective cuff pressure measurement.

Sponsors & Collaborators

  • Cukurova University

    lead OTHER

Principal Investigators

  • Fevzi Güler, MD, Anesthesiologist · Cukurova University Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-10
Primary Completion
2024-10-15
Completion
2024-11-08

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07485972 on ClinicalTrials.gov