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NCT Number: NCT07427173

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Incidence of Postoperative Airway-Related Complications

    Time frame: Postoperative day 1

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

Secondary outcomes

  1. Severity of Postoperative Sore Throat

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

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

  2. Incidence of Hoarseness

    Time frame: Postoperative day 1

    Patient-reported hoarseness evaluated by direct questioning.

  3. Incidence of Dysphagia

    Time frame: Postoperative day 1

    Patient-reported difficulty in swallowing.

  4. Measured Endotracheal Cuff Pressure

    Time frame: Intraoperative - immediately after intubation

    Recorded cuff pressure value (cmH₂O) immediately after intubation.

  5. Duration of Intubation

    Time frame: Intraoperative period (from intubation to extubation)

    Time from intubation to extubation (minutes).

  6. Length of Post-Anesthesia Care Unit (PACU) Stay

    Time frame: Postoperative period - from PACU admission to PACU discharge (same day of surgery).

    Duration of stay in PACU (minutes).

Sponsors and collaborators

Lead sponsor

University of Gaziantep

Other

Registry information

Acronym: ECP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Feb 24, 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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