Postoperative Airway ComplicationsECPNCT07427173
The Impact of Endotracheal Cuff Pressure Assessment Using a Cuff Pressure Manometer Compared With the Traditional Palpation Method on Postoperative Outcomes
An observational study of Postoperative Airway Complications, run by University of Gaziantep.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Airway Complications
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 18 Feb 2026to 1 Sep 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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-
Who cannot join
- 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
Show all 10Show fewer
- Use of systemic steroids in the preoperative period
- More than one attempt required for endotracheal intubation
- Emergency surgeries
- Refusal to participate in the study
About this study
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.
Read the detailed description
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.
- Conditions
- Postoperative Airway Complications
- Keywords
- Postoperative airway complications, Endotracheal cuff pressure management, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Airway-Related Complications
Presence of postoperative sore throat, hoarseness, dysphagia, cough, or laryngeal edema.
Measured: Postoperative day 1
Secondary outcomes (6)
Severity of Postoperative Sore Throat
Assessed using a Visual Analog Scale (VAS, 0-10).
Measured: 1 hour, 6 hours and 24 hours after extubation.
Incidence of Hoarseness
Patient-reported hoarseness evaluated by direct questioning.
Measured: Postoperative day 1
Incidence of Dysphagia
Patient-reported difficulty in swallowing.
Measured: Postoperative day 1
Measured Endotracheal Cuff Pressure
Recorded cuff pressure value (cmH₂O) immediately after intubation.
Measured: Intraoperative - immediately after intubation
Duration of Intubation
Time from intubation to extubation (minutes).
Measured: Intraoperative period (from intubation to extubation)
Length of Post-Anesthesia Care Unit (PACU) Stay
Duration of stay in PACU (minutes).
Measured: Postoperative period - from PACU admission to PACU discharge (same day of surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start18 Feb 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Airway ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Abay, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427173
- Sponsor's protocol ID
- 2025-473
- Acronym
- ECP
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Endotracheal Cuff Pressure Assessment Using a Cuff Pressure Manometer Compared With the Traditional Palpation Method on Postoperative Outcomes
- ClinicalTrials.gov ID
- NCT07427173
- Acronym / sponsor ID
- ECP / 2025-473
- Conditions
- Postoperative Airway Complications
- Keywords
- Postoperative airway complications, Endotracheal cuff pressure management, General anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 18 Feb 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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-
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Postoperative Airway-Related Complications
Time frame: Postoperative day 1
Presence of postoperative sore throat, hoarseness, dysphagia, cough, or laryngeal edema.
6 secondary outcomes
Severity of Postoperative Sore Throat
Time frame: 1 hour, 6 hours and 24 hours after extubation.
Incidence of Hoarseness
Time frame: Postoperative day 1
Incidence of Dysphagia
Time frame: Postoperative day 1
Measured Endotracheal Cuff Pressure
Time frame: Intraoperative - immediately after intubation
Duration of Intubation
Time frame: Intraoperative period (from intubation to extubation)
Length of Post-Anesthesia Care Unit (PACU) Stay
Time frame: Postoperative period - from PACU admission to PACU discharge (same day of surgery).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Airway Complications, run by University of Gaziantep.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Airway-Related Complications (time frame: Postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.