The Impact of Endotracheal Cuff Pressure Assessment Using a Cuff Pressure Manometer Compared With the Traditional Palpation Method on Postoperative Outcomes (ECP)

The aim of this prospective observational study is to evaluate the effect of endotracheal cuff pressure management on postoperative complications in patients undergoing surgery under general anesthesia. Specifically, patients whose endotracheal cuff pressure is maintained at an optimal level using a manometer will be compared with those whose cuff pressure is assessed using the conventional palpation method.

The primary question the study aims to answer is whether maintaining endotracheal cuff pressure at an optimal level with a manometer reduces the incidence of postoperative airway-related complications compared with the classical palpation technique.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Airway Complications

Detailed Description

Endotracheal intubation is routinely performed in patients undergoing surgery under general anesthesia. Maintaining appropriate endotracheal tube cuff pressure is critical to ensure adequate ventilation, prevent aspiration, and minimize tracheal mucosal injury. Excessive cuff pressure may compromise tracheal mucosal perfusion and increase the risk of postoperative airway-related complications such as sore throat, hoarseness, cough, dysphagia, and laryngospasm. Conversely, insufficient cuff pressure may lead to air leakage and aspiration risk.

In routine clinical practice, cuff pressure is frequently assessed using conventional subjective methods such as manual palpation of the pilot balloon. However, this technique does not provide an accurate measurement and may result in pressures outside the recommended safe range (20-30 cmH₂O). Direct measurement using a manometer allows objective monitoring and adjustment of cuff pressure within the optimal range, potentially reducing airway mucosal damage and postoperative laryngeal complications.

This prospective observational study aims to compare two approaches to cuff pressure management in adult patients undergoing elective surgery under general anesthesia with endotracheal intubation:

Patients whose cuff pressure is measured and maintained within the optimal range using a manometer

Patients whose cuff pressure is assessed using conventional methods such as palpation

The primary outcome is the incidence of postoperative airway-related complications within the first 24 hours after extubation. These include sore throat, hoarseness, cough, dysphagia, and laryngospasm.

Secondary outcomes include the severity of postoperative sore throat assessed using a Visual Analog Scale (VAS), the incidence of individual airway symptoms, measured cuff pressure values, duration of intubation, length of stay in the post-anesthesia care unit (PACU), and overall postoperative recovery quality assessed using the Quality of Recovery-15 (QoR-15) questionnaire.

Eligible patients will be prospectively followed during the intraoperative period and evaluated postoperatively at predefined time points (e.g., 1, 6, and 24 hours after extubation). Demographic data, perioperative variables, and airway-related outcomes will be recorded and analyzed to determine whether objective cuff pressure monitoring with a manometer is associated with improved postoperative airway outcomes compared with conventional subjective assessment methods.

This study is expected to provide clinically relevant evidence regarding optimal endotracheal cuff pressure management and its impact on postoperative airway morbidity.

• Study Type: Observational
• Enrollment (Estimated): 104

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients aged 18-75 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, with a body mass index between 18 and 30 kg/m², who are scheduled to undergo elective surgery under general anesthesia requiring endotracheal intubation. Only patients with successful intubation on the first attempt will be included.

Description

Inclusion Criteria:

• Patients aged 18-75 years
• American Society of Anesthesiologists (ASA) physical status I-III
• Body mass index (BMI) between 18 and 30 kg/m²
• Undergoing surgery under general anesthesia
• Successful endotracheal intubation on the first attempt -Provided written informed consent and willing to participate in the study-

Exclusion Criteria:

• Patients younger than 18 years or older than 75 years
• American Society of Anesthesiologists (ASA) physical status IV-VI
• Patients undergoing head and neck surgery
• History of chronic pulmonary disease (e.g., asthma, chronic obstructive pulmonary disease)
• Presence of preoperative sore throat
• History of upper or lower respiratory tract infection within the past 2 weeks
• Use of systemic steroids in the preoperative period
• More than one attempt required for endotracheal intubation
• Emergency surgeries
• Refusal to participate in the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Manual Palpation; Patients whose endotracheal cuff pressure was maintained using the manual palpation method.
Cuff Pressure Manometer; Patients whose endotracheal cuff pressure was maintained using the cuff manometer method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative Airway-Related Complications	Presence of postoperative sore throat, hoarseness, dysphagia, cough, or laryngeal edema.	Postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Postoperative Sore Throat	Assessed using a Visual Analog Scale (VAS, 0-10).	1 hour, 6 hours and 24 hours after extubation.
Incidence of Hoarseness	Patient-reported hoarseness evaluated by direct questioning.	Postoperative day 1
Incidence of Dysphagia	Patient-reported difficulty in swallowing.	Postoperative day 1
Measured Endotracheal Cuff Pressure	Recorded cuff pressure value (cmH₂O) immediately after intubation.	Intraoperative - immediately after intubation
Duration of Intubation	Time from intubation to extubation (minutes).	Intraoperative period (from intubation to extubation)
Length of Post-Anesthesia Care Unit (PACU) Stay	Duration of stay in PACU (minutes).	Postoperative period - from PACU admission to PACU discharge (same day of surgery).

Collaborators and Investigators

• Sponsor: University of Gaziantep

Study record dates

Study Major Dates

• Study Start (Estimated): February 18, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 15, 2026
• First Submitted That Met QC Criteria: February 15, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 21, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: General anesthesia; Postoperative airway complications; Endotracheal cuff pressure management
• Other Study ID Numbers: 2025-473

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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