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

NCT07427173 | Not Yet Recruiting

• 1 other identifier: 2025-473
• Study Type: observational
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Airway Complications

Keywords

Postoperative airway complications; Endotracheal cuff pressure management; General anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Airway-Related Complications

  Presence of postoperative sore throat, hoarseness, dysphagia, cough, or laryngeal edema.

  Postoperative day 1

Secondary Outcomes (6)

• Severity of Postoperative Sore Throat

  1 hour, 6 hours and 24 hours after extubation.

• Incidence of Hoarseness

  Postoperative day 1

• Incidence of Dysphagia

  Postoperative day 1

• Measured Endotracheal Cuff Pressure

  Intraoperative - immediately after intubation

• Duration of Intubation

  Intraoperative period (from intubation to extubation)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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-

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Gaziantep: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Assistant Doctor

Study Record Dates

• First Submitted: February 15, 2026
• First Posted: February 23, 2026
• Study Start: February 18, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02