Postoperative Airway ComplicationsNCT07485972
Continuous Endotracheal Tube Cuff Pressure Monitoring and Postoperative Airway Complications in Laparoscopic Surgery
A study testing Intermittent cuff pressure monitoring, Continuous cuff pressure monitoring and Cuff-leak technique in people with Postoperative Airway Complications and Postoperative Sore Throat, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized controlled study evaluated the effects of different endotracheal tube cuff pressure monitoring strategies on postoperative airway complications in patients undergoing elective laparoscopic abdominal surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Airway Complications, Postoperative Sore Throat, Endotracheal Tube Cuff Pressure
- What is being tested?
- Intermittent cuff pressure monitoring, Continuous cuff pressure monitoring and Cuff-leak technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2024to 8 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years
- ASA physical status I-II
- Scheduled for elective laparoscopic abdominal surgery under general anesthesia
- Expected surgery duration longer than 90 minutes
Who cannot join
- Predicted difficult airway
- Recent upper respiratory tract infection
- Preoperative laryngopharyngeal symptoms
- Recent endotracheal intubation
- Body mass index > 40 kg/m²
- Substance abuse
Show all 10Show fewer
- History of bronchospasm
- Tracheostomy
- History of laryngeal disease or laryngeal surgery
- ASA physical status ≥ III
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukurova University Faculty of Medicine, Department of Anesthesiology and Reanimation
Adana, Adana, 01330
About this study
Official title: Effects of Continuous Endotracheal Tube Cuff Pressure Monitoring on Postoperative Airway Complications in Laparoscopic Surgery: A Randomized Controlled Trial
This prospective randomized controlled study evaluated the effects of different endotracheal tube cuff pressure monitoring strategies on postoperative airway complications in patients undergoing elective laparoscopic abdominal surgery under general anesthesia. Excessive endotracheal tube cuff pressure may impair tracheal mucosal perfusion and lead to postoperative airway symptoms such as sore throat, cough, dysphagia, hoarseness, and hemoptysis.
A total of 95 adult patients (ASA I-II) aged 18-65 years were randomly assigned to one of three groups according to the cuff pressure monitoring technique used during surgery: the cuff-leak technique (control group), intermittent cuff pressure monitoring using a manual manometer every 30 minutes, or continuous cuff pressure monitoring using a pressure transducer connected to the pilot balloon.
The primary outcome was the incidence of cuff-related postoperative airway complications at postoperative hours 2 and 24. Secondary outcomes included tracheal mucosal injury assessed by fiberoptic bronchoscopy before extubation and its association with postoperative airway symptoms. The study aimed to determine whether continuous cuff pressure monitoring reduces postoperative airway complications and tracheal mucosal injury compared with intermittent monitoring and the cuff-leak technique.
Read the detailed description
Endotracheal tube cuff pressure should be maintained between 20 and 30 cmH₂O to ensure adequate ventilation while preventing tracheal mucosal ischemia. Excessive cuff pressure may compromise tracheal mucosal perfusion and lead to postoperative airway complications such as sore throat, cough, hoarseness, dysphagia, and hemoptysis. In laparoscopic surgery, factors such as pneumoperitoneum, patient positioning, and the use of nitrous oxide may contribute to progressive increases in cuff pressure during anesthesia.
This prospective randomized controlled trial was conducted to evaluate the impact of different cuff pressure monitoring strategies on postoperative airway complications and tracheal mucosal injury in adult patients undergoing elective laparoscopic abdominal surgery. After obtaining ethical approval and written informed consent, patients were randomized into three groups according to the cuff pressure monitoring method used intraoperatively: cuff inflation using the cuff-leak technique (control group), intermittent cuff pressure monitoring with a manual manometer every 30 minutes, or continuous cuff pressure monitoring using a pressure transducer connected to the pilot balloon.
Cuff pressure in the monitored groups was maintained at approximately 25 cmH₂O throughout surgery. Postoperative laryngopharyngeal symptoms, including sore throat, cough, dysphagia, hoarseness, and hemoptysis, were assessed at postoperative hours 2 and 24 by a blinded observer. Tracheal mucosal changes were evaluated using fiberoptic bronchoscopy before extubation and graded according to established criteria.
The aim of the study was to determine whether continuous cuff pressure monitoring provides better control of cuff pressure and reduces postoperative airway complications and tracheal mucosal injury compared with intermittent monitoring and the cuff-leak technique.
- Conditions
- Postoperative Airway Complications, Postoperative Sore Throat, Endotracheal Tube Cuff Pressure
- Being tested
- Intermittent cuff pressure monitoring, Continuous cuff pressure monitoring, Cuff-leak technique
- Keywords
- Continuous cuff pressure monitoring, endotracheal tube cuff pressure, fiberoptic bronchoscopy, postoperative sore throat, tracheal mucosal injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent cuff pressure monitoringProcedure or surgery
Endotracheal tube cuff pressure was adjusted to 25 cmH₂O using a manual manometer and rechecked every 30 minutes during surgery. If the pressure was outside the range of 20-30 cmH₂O, it was readjusted accordingly.
Continuous cuff pressure monitoringProcedure or surgery
Endotracheal tube cuff pressure was continuously monitored using a pressure transducer connected to the pilot balloon via a three-way stopcock and maintained at approximately 25 cmH₂O throughout surgery.
Cuff-leak techniqueProcedure or surgery
The endotracheal tube cuff was inflated using the cuff-leak technique without objective cuff pressure measurement.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Cuff Pressure Monitoring | Experimental | Endotracheal tube cuff pressure was adjusted to 25 cmH₂O using a manual manometer and rechecked every 30 minutes during surgery. If cuff pressure was outside the range of 20-30 cmH₂O, it was readjusted accordingly. Receives: Procedure: Intermittent cuff pressure monitoring |
| Continuous Cuff Pressure Monitoring | Experimental | Endotracheal tube cuff pressure was continuously monitored using a pressure transducer connected to the pilot balloon via a three-way stopcock. Cuff pressure was maintained at approximately 25 cmH₂O throughout surgery. Receives: Procedure: Continuous cuff pressure monitoring |
| Cuff-Leak Technique (Control) | Active comparator | The endotracheal tube cuff was inflated using the cuff-leak technique without objective cuff pressure measurement. Receives: Procedure: Cuff-leak technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative airway complications
The incidence of postoperative airway complications including sore throat, cough, dysphagia, hoarseness, and hemoptysis assessed at postoperative hours 2 and 24.
Measured: Postoperative 2 hours and 24 hours
Secondary outcomes (1)
Tracheal mucosal injury assessed by fiberoptic bronchoscopy
Tracheal mucosal injury evaluated using fiberoptic bronchoscopy before extubation and graded according to mucosal findings (no injury, focal hyperemia, local hyperemia, hemorrhagic ulceration).
Measured: Before extubation (end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start10 May 2024
- Primary completion15 Oct 2024
- Study completion8 Nov 2024
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.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of three parallel groups according to the endotracheal tube cuff pressure monitoring strategy used during surgery: intermittent cuff pressure monitoring with a manual manometer every 30 minutes, continuous cuff pressure monitoring using a pressure transducer connected to the pilot balloon, or the cuff-leak technique without pressure measurement (control group).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fevzi Güler, Cukurova University
- Investigators
- Fevzi Güler, MD, Anesthesiologist, Principal investigator, Cukurova University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485972
- Sponsor's protocol ID
- 144/17
- Other IDs
- 144/17
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data because the dataset contains confidential patient information and was collected for a single-center academic study.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Endotracheal Tube Cuff Pressure Monitoring on Postoperative Airway Complications in Laparoscopic Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07485972
- Acronym / sponsor ID
- 144/17
- Conditions
- Postoperative Airway Complications, Postoperative Sore Throat, Endotracheal Tube Cuff Pressure
- Keywords
- Continuous cuff pressure monitoring, endotracheal tube cuff pressure, fiberoptic bronchoscopy, postoperative sore throat, tracheal mucosal injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 20 Mar 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.
This prospective randomized controlled study evaluated the effects of different endotracheal tube cuff pressure monitoring strategies on postoperative airway complications in patients undergoing elective laparoscopic abdominal surgery under general anesthesia. Excessive endotracheal tube cuff pressure may impair tracheal mucosal perfusion and lead to postoperative airway symptoms such as sore throat, cough, dysphagia, hoarseness, and hemoptysis.
A total of 95 adult patients (ASA I-II) aged 18-65 years were randomly assigned to one of three groups according to the cuff pressure monitoring technique used during surgery: the cuff-leak technique (control group), intermittent cuff pressure monitoring using a manual manometer every 30 minutes, or continuous cuff pressure monitoring using a pressure transducer connected to the pilot balloon.
The primary outcome was the incidence of cuff-related postoperative airway complications at postoperative hours 2 and 24. Secondary outcomes included tracheal mucosal injury assessed by fiberoptic bronchoscopy before extubation and its association with postoperative airway symptoms. The study aimed to determine whether continuous cuff pressure monitoring reduces postoperative airway complications and tracheal mucosal injury compared with intermittent monitoring and the cuff-leak technique.
Detailed description
Endotracheal tube cuff pressure should be maintained between 20 and 30 cmH₂O to ensure adequate ventilation while preventing tracheal mucosal ischemia. Excessive cuff pressure may compromise tracheal mucosal perfusion and lead to postoperative airway complications such as sore throat, cough, hoarseness, dysphagia, and hemoptysis. In laparoscopic surgery, factors such as pneumoperitoneum, patient positioning, and the use of nitrous oxide may contribute to progressive increases in cuff pressure during anesthesia.
This prospective randomized controlled trial was conducted to evaluate the impact of different cuff pressure monitoring strategies on postoperative airway complications and tracheal mucosal injury in adult patients undergoing elective laparoscopic abdominal surgery. After obtaining ethical approval and written informed consent, patients were randomized into three groups according to the cuff pressure monitoring method used intraoperatively: cuff inflation using the cuff-leak technique (control group), intermittent cuff pressure monitoring with a manual manometer every 30 minutes, or continuous cuff pressure monitoring using a pressure transducer connected to the pilot balloon.
Cuff pressure in the monitored groups was maintained at approximately 25 cmH₂O throughout surgery. Postoperative laryngopharyngeal symptoms, including sore throat, cough, dysphagia, hoarseness, and hemoptysis, were assessed at postoperative hours 2 and 24 by a blinded observer. Tracheal mucosal changes were evaluated using fiberoptic bronchoscopy before extubation and graded according to established criteria.
The aim of the study was to determine whether continuous cuff pressure monitoring provides better control of cuff pressure and reduces postoperative airway complications and tracheal mucosal injury compared with intermittent monitoring and the cuff-leak technique.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomly assigned to one of three parallel groups according to the endotracheal tube cuff pressure monitoring strategy used during surgery: intermittent cuff pressure monitoring with a manual manometer every 30 minutes, continuous cuff pressure monitoring using a pressure transducer connected to the pilot balloon, or the cuff-leak technique without pressure measurement (control group).
| Arm | Type | Receives |
|---|---|---|
| Intermittent Cuff Pressure Monitoring | Experimental | Procedure: Intermittent cuff pressure monitoringEndotracheal tube cuff pressure was adjusted to 25 cmH₂O using a manual manometer and rechecked every 30 minutes during surgery. If cuff pressure was outside the range of 20-30 cmH₂O, it was readjusted accordingly. |
| Continuous Cuff Pressure Monitoring | Experimental | Procedure: Continuous cuff pressure monitoringEndotracheal tube cuff pressure was continuously monitored using a pressure transducer connected to the pilot balloon via a three-way stopcock. Cuff pressure was maintained at approximately 25 cmH₂O throughout surgery. |
| Cuff-Leak Technique (Control) | Active comparator | Procedure: Cuff-leak techniqueThe endotracheal tube cuff was inflated using the cuff-leak technique without objective cuff pressure measurement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-65 years
- ASA physical status I-II
- Scheduled for elective laparoscopic abdominal surgery under general anesthesia
- Expected surgery duration longer than 90 minutes
Key exclusion criteria (10 listed)
- Predicted difficult airway
- Recent upper respiratory tract infection
- Preoperative laryngopharyngeal symptoms
- Recent endotracheal intubation
- Body mass index > 40 kg/m²
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent cuff pressure monitoringEndotracheal tube cuff pressure was adjusted to 25 cmH₂O using a manual manometer and rechecked every 30 minutes during surgery. If the pressure was outside the range of 20-30 cmH₂O, it was readjusted accordingly. | Procedure or surgery | Intermittent Cuff Pressure Monitoring |
| Continuous cuff pressure monitoringEndotracheal tube cuff pressure was continuously monitored using a pressure transducer connected to the pilot balloon via a three-way stopcock and maintained at approximately 25 cmH₂O throughout surgery. | Procedure or surgery | Continuous Cuff Pressure Monitoring |
| Cuff-leak techniqueThe endotracheal tube cuff was inflated using the cuff-leak technique without objective cuff pressure measurement. | Procedure or surgery | Cuff-Leak Technique (Control) |
Primary outcome
Incidence of postoperative airway complications
Time frame: Postoperative 2 hours and 24 hours
The incidence of postoperative airway complications including sore throat, cough, dysphagia, hoarseness, and hemoptysis assessed at postoperative hours 2 and 24.
1 secondary outcome
Tracheal mucosal injury assessed by fiberoptic bronchoscopy
Time frame: Before extubation (end of surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No. No plan to share individual participant data because the dataset contains confidential patient information and was collected for a single-center academic study.
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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. This study is not recruiting at the moment.
Fevzi Güler, MD, Anesthesiologist principal investigator
Cukurova University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent cuff pressure monitoring, Continuous cuff pressure monitoring and Cuff-leak technique in people with Postoperative Airway Complications and Postoperative Sore Throat, run by Cukurova University at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 complications (time frame: Postoperative 2 hours and 24 hours). 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 20 Mar 2026.