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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07485972
Enrollment
95
Registered
2026-03-20
Start date
2024-05-10
Completion date
2024-11-08
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

PROCEDUREIntermittent 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.

PROCEDUREContinuous 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.

PROCEDURECuff-leak technique

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

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessments were performed by an independent investigator who was blinded to group allocation.

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative airway complicationsPostoperative 2 hours and 24 hoursThe incidence of postoperative airway complications including sore throat, cough, dysphagia, hoarseness, and hemoptysis assessed at postoperative hours 2 and 24.

Secondary

MeasureTime frameDescription
Tracheal mucosal injury assessed by fiberoptic bronchoscopyBefore extubation (end of surgery)Tracheal mucosal injury evaluated using fiberoptic bronchoscopy before extubation and graded according to mucosal findings (no injury, focal hyperemia, local hyperemia, hemorrhagic ulceration).

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORFevzi Güler, MD, Anesthesiologist

Cukurova University Faculty of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026