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

Effects of Continuous Endotracheal Tube Cuff Pressure Monitoring on Postoperative Airway Complications in Laparoscopic Surgery: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Sore Throat; Endotracheal Tube Cuff Pressure; Postoperative Airway Complications
• Intervention / Treatment: Procedure: Intermittent cuff pressure monitoring; Procedure: Continuous cuff pressure monitoring; Procedure: Cuff-leak technique

Detailed Description

Endotracheal tube cuff pressure should be maintained between 20 and 30 cmH₂O to ensure adequate ventilation while preventing tracheal mucosal ischemia. Excessive cuff pressure may compromise tracheal mucosal perfusion and lead to postoperative airway complications such as sore throat, cough, hoarseness, dysphagia, and hemoptysis. In laparoscopic surgery, factors such as pneumoperitoneum, patient positioning, and the use of nitrous oxide may contribute to progressive increases in cuff pressure during anesthesia.

This prospective randomized controlled trial was conducted to evaluate the impact of different cuff pressure monitoring strategies on postoperative airway complications and tracheal mucosal injury in adult patients undergoing elective laparoscopic abdominal surgery. After obtaining ethical approval and written informed consent, patients were randomized into three groups according to the cuff pressure monitoring method used intraoperatively: cuff inflation using the cuff-leak technique (control group), intermittent cuff pressure monitoring with a manual manometer every 30 minutes, or continuous cuff pressure monitoring using a pressure transducer connected to the pilot balloon.

Cuff pressure in the monitored groups was maintained at approximately 25 cmH₂O throughout surgery. Postoperative laryngopharyngeal symptoms, including sore throat, cough, dysphagia, hoarseness, and hemoptysis, were assessed at postoperative hours 2 and 24 by a blinded observer. Tracheal mucosal changes were evaluated using fiberoptic bronchoscopy before extubation and graded according to established criteria.

The aim of the study was to determine whether continuous cuff pressure monitoring provides better control of cuff pressure and reduces postoperative airway complications and tracheal mucosal injury compared with intermittent monitoring and the cuff-leak technique.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Adana
    • Adana, Adana, Turkey (Türkiye), 01330
      • Cukurova University Faculty of Medicine, Department of Anesthesiology and Reanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 cuff pressure was outside the range of 20-30 cmH₂O, it was readjusted accordingly.	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.
Experimental: 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. Cuff pressure was maintained at approximately 25 cmH₂O throughout surgery.	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.
Active Comparator: Cuff-Leak Technique (Control); The endotracheal tube cuff was inflated using the cuff-leak technique without objective cuff pressure measurement.	Procedure: Cuff-leak technique; The endotracheal tube cuff was inflated using the cuff-leak technique without objective cuff pressure measurement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tracheal mucosal injury assessed by fiberoptic bronchoscopy	Tracheal mucosal injury evaluated using fiberoptic bronchoscopy before extubation and graded according to mucosal findings (no injury, focal hyperemia, local hyperemia, hemorrhagic ulceration).	Before extubation (end of surgery)

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Principal Investigator: Fevzi Güler, MD, Anesthesiologist, Cukurova University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): November 8, 2024

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: fiberoptic bronchoscopy; postoperative sore throat; endotracheal tube cuff pressure; Continuous cuff pressure monitoring; tracheal mucosal injury
• Other Study ID Numbers: 144/17 (Other Grant/Funding Number: Cukurova University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share individual participant data because the dataset contains confidential patient information and was collected for a single-center academic study.

Drug and device information, study documents

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