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NCT Number: NCT07842081

Scheduled Endotracheal Tube Cuff Pressure Management and Postoperative Sore Throat

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.

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Key information

Conditions

Postoperative Sore Throat Deglutition Disorders Digestive System Diseases Endotracheal Intubation Esophageal Diseases Gastrointestinal Diseases Hoarseness Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Voice Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hitit University Erol Olçok Training and Research Hospital

Çorum, 19030, Turkey (Türkiye)

About this study

This was a prospective, randomized, parallel-group controlled trial conducted in adults undergoing elective surgery under general anesthesia with planned endotracheal intubation.

Eligible participants were randomized in a 1:1 ratio to one of two cuff-pressure management strategies.

In the manometer-guided group, endotracheal tube cuff pressure was initially adjusted to a target range of 25-30 cmH₂O using a calibrated handheld cuff manometer. Cuff pressure was subsequently assessed immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation. At each scheduled assessment after the initial adjustment, cuff pressure was recorded before adjustment and was readjusted to 25-30 cmH₂O when necessary.

In the conventional pilot-balloon palpation group, cuff inflation was performed according to the attending anesthesiologist's subjective assessment of the pilot balloon. Cuff pressure was measured using the same manometer at the predefined study time points for study documentation, but the measured values were not used to guide cuff-pressure adjustment.

Postoperative outcomes were assessed by an investigator blinded to treatment allocation. Postoperative sore throat was evaluated at 1, 6, and 24 hours after extubation using a 10-point numerical rating scale. The primary outcome was the occurrence of any postoperative sore throat within 24 hours. Additional postoperative airway symptoms and cuff-pressure-related outcomes were also evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Occurrence of Postoperative Sore Throat Within 24 Hours

    Time frame: From 1 hour to 24 hours after extubation

    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.

Secondary outcomes

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

    Time frame: 1, 6, and 24 hours after extubation

    Postoperative sore throat severity was assessed using a 10-point numerical rating scale (NRS), where 1 indicated no sore throat and higher scores indicated increasing symptom severity.

  2. Postoperative Sore Throat Occurrence at Individual Time Points

    Time frame: 1, 6, and 24 hours after extubation

    The occurrence of postoperative sore throat was evaluated separately at 1, 6, and 24 hours after extubation.

  3. Endotracheal Tube Cuff Pressure at Scheduled Intraoperative Time Points

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

    Endotracheal tube cuff pressure was measured using a handheld cuff manometer immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation. Cuff-pressure values were compared between the study groups.

  4. Proportion of Cuff Pressure Measurements Within the Target Range

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

    The proportion of cuff-pressure measurements within the predefined target range of 25-30 cmH₂O was evaluated at the scheduled intraoperative measurement time points.

Other outcomes

  1. Occurrence of Postoperative Hoarseness

    Time frame: Within 24 hours after extubation

    Postoperative hoarseness was assessed following extubation.

  2. Occurrence of Postoperative Dysphagia

    Time frame: Within 24 hours after extubation

    Postoperative difficulty swallowing (dysphagia) was assessed following extubation.

  3. Occurrence of Postoperative Cough

    Time frame: Within 24 hours after extubation

    Postoperative cough was assessed following extubation.

  4. Occurrence of Postoperative Nausea or Vomiting

    Time frame: within 24 hours after extubation

    Postoperative nausea or vomiting was assessed following surgery.

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Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Official study title

Scheduled Manometer-Guided Endotracheal Tube Cuff-Pressure Management Versus Pilot-Balloon Palpation for Reducing Postoperative Sore Throat in Adults Undergoing Elective Surgery With Tracheal Intubation: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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