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

NCT07485972 | Completed

• 1 other identifier: 144/17
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Continuous cuff pressure monitoring; endotracheal tube cuff pressure; fiberoptic bronchoscopy; postoperative sore throat; tracheal mucosal injury

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative airway complications

  The incidence of postoperative airway complications including sore throat, cough, dysphagia, hoarseness, and hemoptysis assessed at postoperative hours 2 and 24.

  Postoperative 2 hours and 24 hours

Secondary Outcomes (1)

• Tracheal mucosal injury assessed by fiberoptic bronchoscopy

  Before extubation (end of surgery)

Study Arms (3)

Intermittent Cuff Pressure Monitoring

EXPERIMENTAL

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

Procedure: Intermittent cuff pressure monitoring

Continuous Cuff Pressure Monitoring

EXPERIMENTAL

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

Procedure: Continuous cuff pressure monitoring

Cuff-Leak Technique (Control)

ACTIVE COMPARATOR

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

Procedure: Cuff-leak technique

Interventions

Intermittent cuff pressure monitoring PROCEDURE

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.

Intermittent Cuff Pressure Monitoring

Continuous cuff pressure monitoring PROCEDURE

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.

Continuous Cuff Pressure Monitoring

Cuff-leak technique PROCEDURE

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

Cuff-Leak Technique (Control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-65 years
• ASA physical status I-II
• Scheduled for elective laparoscopic abdominal surgery under general anesthesia
• Expected surgery duration longer than 90 minutes

You may not qualify if:

• Predicted difficult airway
• Recent upper respiratory tract infection
• Preoperative laryngopharyngeal symptoms
• Recent endotracheal intubation
• Body mass index \> 40 kg/m²
• Substance abuse
• History of bronchospasm
• Tracheostomy
• History of laryngeal disease or laryngeal surgery
• ASA physical status ≥ III

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University Faculty of Medicine, Department of Anesthesiology and Reanimation

Adana, Adana, 01330, Turkey (Türkiye)

Location

Study Officials

• Fevzi Güler, MD, Anesthesiologist

  Cukurova University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments were performed by an independent investigator who was blinded to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Anesthesiology and Reanimation

Model Details: Participants were randomly assigned to one of three parallel groups according to the endotracheal tube cuff pressure monitoring strategy used during surgery: intermittent cuff pressure monitoring with a manual manometer every 30 minutes, continuous cuff pressure monitoring using a pressure transducer connected to the pilot balloon, or the cuff-leak technique without pressure measurement (control group).

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 20, 2026
• Study Start: May 10, 2024
• Primary Completion: October 15, 2024
• Study Completion: November 8, 2024
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)