Scheduled Endotracheal Tube Cuff Pressure Management and Postoperative Sore Throat

NCT07842081 | Completed

• 1 other identifier: HITIT-ETT-CUFF-2025-01
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluated whether scheduled measurement and adjustment of endotracheal tube cuff pressure using a handheld manometer could reduce postoperative sore throat in adults undergoing elective surgery under general anesthesia with tracheal intubation. Participants were randomly assigned in a 1:1 ratio to either manometer-guided cuff-pressure management or conventional cuff inflation based on pilot-balloon palpation. In the manometer-guided group, cuff pressure was maintained within a target range of 25-30 cmH₂O. In the conventional group, cuff inflation was managed according to the attending anesthesiologist's usual clinical assessment. Cuff pressure was assessed at predefined time points during anesthesia. Postoperative sore throat was evaluated at 1, 6, and 24 hours after extubation. Other postoperative airway symptoms, including hoarseness, difficulty swallowing, cough, and postoperative nausea or vomiting, were also assessed. The main objective was to determine whether scheduled manometer-guided cuff-pressure management reduced the occurrence of postoperative sore throat within the first 24 hours after surgery compared with conventional pilot-balloon palpation.

Conditions

Postoperative Sore Throat; Endotracheal Intubation

Keywords

Endotracheal Intubation; Endotracheal Tube Cuff Pressure; Cuff Manometer; Pilot Balloon Palpation; General Anesthesia; Postoperative Airway Symptoms; Hoarseness; Dysphagia

Outcome Measures

Primary Outcomes (1)

• Occurrence of Postoperative Sore Throat Within 24 Hours

  Postoperative sore throat was assessed using a 10-point numerical rating scale (NRS) at 1, 6, and 24 hours after extubation. The primary outcome was defined as the occurrence of any postoperative sore throat within 24 hours, corresponding to an NRS score greater than 1 at any scheduled assessment.

  From 1 hour to 24 hours after extubation

Secondary Outcomes (4)

• Postoperative Sore Throat Severity at 1, 6, and 24 Hours

  1, 6, and 24 hours after extubation

• Postoperative Sore Throat Occurrence at Individual Time Points

  1, 6, and 24 hours after extubation

• Endotracheal Tube Cuff Pressure at Scheduled Intraoperative Time Points

  Immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation

• Proportion of Cuff Pressure Measurements Within the Target Range

  Immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation

Other Outcomes (4)

• Occurrence of Postoperative Hoarseness

  Within 24 hours after extubation

• Occurrence of Postoperative Dysphagia

  Within 24 hours after extubation

• Occurrence of Postoperative Cough

  Within 24 hours after extubation

Study Arms (2)

Manometer-Guided Cuff Pressure Management

EXPERIMENTAL

Participants assigned to this arm underwent scheduled endotracheal tube cuff-pressure measurement using a handheld cuff manometer. Cuff pressure was initially adjusted to 25-30 cmH₂O and was reassessed immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation. At subsequent assessments, cuff pressure was readjusted to the target range when necessary.

Device: Handheld Endotracheal Tube Cuff Manometer

Pilot-Balloon Palpation

ACTIVE COMPARATOR

Participants assigned to this arm underwent conventional endotracheal tube cuff inflation based on the attending anesthesiologist's subjective assessment of the pilot balloon. Cuff pressure was measured at the predefined study time points for study documentation only and was not used to guide pressure adjustment.

Procedure: Pilot-Balloon Palpation

Interventions

Handheld Endotracheal Tube Cuff Manometer DEVICE

Endotracheal tube cuff pressure was measured using a handheld cuff manometer and adjusted to a target range of 25-30 cmH₂O. Measurements were performed immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation.

Manometer-Guided Cuff Pressure Management

Pilot-Balloon Palpation PROCEDURE

Endotracheal tube cuff inflation was managed according to the attending anesthesiologist's subjective assessment of the pilot balloon. Cuff pressure was measured at the predefined study time points for study documentation only, without pressure-directed adjustment.

Pilot-Balloon Palpation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Scheduled for elective surgery under general anesthesia with planned endotracheal intubation.
• Provided written informed consent.

You may not qualify if:

• Active upper respiratory tract infection on the day of surgery.
• Anticipated difficult airway.
• Anatomical laryngotracheal abnormality.
• Previous surgery or radiotherapy involving the laryngotracheal region.
• Anticipated need for postoperative tracheal intubation lasting more than 24 hours.

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Hitit University Erol Olçok Training and Research Hospital

Çorum, 19030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hoarseness; Deglutition Disorders

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases

Study Officials

• Semin Turhan

  Hitit University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Postoperative outcomes were assessed by an investigator who was blinded to treatment allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of General Surgery

Model Details: Participants were randomized in a 1:1 ratio to either scheduled manometer-guided endotracheal tube cuff-pressure management or conventional pilot-balloon palpation.

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start: May 13, 2025
• Primary Completion: November 18, 2025
• Study Completion: November 18, 2025
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data and supporting documents will be available after publication of the primary study results and may remain available for a reasonable period thereafter, subject to institutional and ethical approval.
• Access Criteria: Qualified researchers with a scientifically sound proposal may request access to de-identified individual participant data and supporting documents. Requests will be reviewed by the corresponding author and, when required, by the relevant institution. Access will be granted only after appropriate approval and under conditions that protect participant confidentiality.

Locations

TU (1)