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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversity of Gaziantep

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

104 Participants
are grouped into 2 trial groups
Group A: Manual Palpation
Group B: Cuff Pressure Manometer

Trial outcomes

Primary outcomes

1

Incidence of Postoperative Airway-Related Complications

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

Time frame
Postoperative day 1

Secondary outcomes

1

Severity of Postoperative Sore Throat

Assessed using a Visual Analog Scale (VAS, 0-10).

Time frame
1 hour, 6 hours and 24 hours after extubation.
2

Incidence of Hoarseness

Patient-reported hoarseness evaluated by direct questioning.

Time frame
Postoperative day 1
3

Incidence of Dysphagia

Patient-reported difficulty in swallowing.

Time frame
Postoperative day 1
4

Measured Endotracheal Cuff Pressure

Recorded cuff pressure value (cmH₂O) immediately after intubation.

Time frame
Intraoperative - immediately after intubation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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