Airway ComplicationsNCT07341646
Effect of Cuff Pressure Assessment Methods on Postoperative Complications in Breast Surgery
A study testing Continuous Cuff Pressure Indicator, Manual Cuff Pressure Manometer and Minimal Occlusive Volume Technique in people with Airway Complications and Postoperative Sore Throat, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Endotracheal intubation is a standard procedure used to secure the airway during general anesthesia. A key component of the breathing tube is the "cuff," a balloon-like device that is inflated to seal the airway and prevent aspiration. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Airway Complications, Postoperative Sore Throat, Hoarseness
- What is being tested?
- Continuous Cuff Pressure Indicator, Manual Cuff Pressure Manometer and Minimal Occlusive Volume Technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Jun 2027
- Phase
- Interventional
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 to 65 years.
- Patients classified as American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Patients scheduled for elective breast surgery requiring general anesthesia and endotracheal intubation.
- Patients who provide voluntary written informed consent to participate.
Who cannot join
- Patients with a history of Chronic Obstructive Pulmonary Disease (COPD) or an asthma attack within the last 6 months.
- Presence of preoperative sore throat, hoarseness, or cough.
- Patients with predicted difficult intubation or those who are difficult to intubate.
- Patients with communication difficulties that prevent accurate assessment of symptoms.
- Patients whose surgery duration exceeds 3 hours.
- Patients older than 65 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Izmir Katip Celebi University Atatürk Training and Research Hospital
Izmir, Karabaglar, 35360
Pınar Durak, M.D., +90 535 399 59 52, pinaardurak@icloud.com
Ahmet Salih Tüzen, M.D., +90 535 391 55 77, astuzen@icloud.com
About this study
Official title: The Effect of Endotracheal Tube Cuff Pressure Assessment Methods on Postoperative Complications in Patients Undergoing Elective Breast Surgery: A Randomized Controlled Trial
Endotracheal intubation is a standard procedure used to secure the airway during general anesthesia. A key component of the breathing tube is the "cuff," a balloon-like device that is inflated to seal the airway and prevent aspiration. However, if the pressure within this cuff is too high, it can restrict blood flow to the tracheal lining, leading to complications such as postoperative sore throat, hoarseness, and difficulty swallowing (dysphagia).
Currently, there are various methods to monitor and adjust this pressure. In many clinical practices, the pressure is adjusted subjectively or checked only once at the beginning of the surgery. These methods may allow pressure to exceed safe limits (typically 20-30 cmH₂O) or fluctuate during the procedure, potentially causing tissue irritation. This randomized controlled trial aims to compare three different methods of assessing and maintaining endotracheal tube cuff pressure to determine which is most effective at reducing postoperative complications. The study focuses on women undergoing elective breast surgery, a group chosen because the surgery typically lasts 1-3 hours and does not involve major changes in head and neck position, allowing for a clear assessment of the cuff pressure methods.
Read more
Participants will be randomly assigned to one of three groups:
- Continuous Monitoring Group: Cuff pressure is monitored continuously using a pressure indicator and maintained within the 20-30 cmH₂O range throughout the surgery.
- Manometer Group: Cuff pressure is measured and set to 20-30 cmH₂O using a manual manometer once, immediately after intubation.
- Control Group (Minimal Occlusive Volume): The cuff is inflated with the minimum amount of air required to prevent an air leak, without using a pressure gauge.
Researchers will assess patients for sore throat, cough, hoarseness, and swallowing difficulties at 0, 1, 12, and 24 hours after surgery to identify the safest and most comfortable method for airway management.
Read the detailed description
This prospective, randomized, parallel-group, single-blind clinical trial investigates the efficacy of different endotracheal tube cuff pressure monitoring techniques in preventing postoperative airway morbidity. The study will be conducted at the İzmir Kâtip Çelebi University Atatürk Training and Research Hospital, Department of Anesthesiology and Reanimation.
The study population consists of female patients aged 18-65 years, classified as ASA I-III, who are scheduled for elective breast surgery under general anesthesia requiring endotracheal intubation. Breast surgery patients were selected as the target population because they represent a homogenous group (typically healthy females), undergo procedures of moderate duration (1-3 hours), and remain in a fixed supine position without significant head-neck manipulation, thereby minimizing confounding variables that could affect cuff pressure.
Study Procedures and Randomization: A total of 90 eligible patients will be enrolled. After providing informed consent, participants will be randomized into three groups with a 1:1:1 allocation ratio. Randomization will be performed using a computer-generated random sequence (via Research Randomizer, randomizer.org) to ensure unbiased assignment. The allocation sequence will be concealed from the investigators until the patient has been successfully intubated.
The three study arms are defined as follows:
- Continuous Pressure Indicator Group: Cuff pressure will be continuously monitored and maintained within the therapeutic range of 20-30 cmH₂O using a continuous pressure indicator device throughout the surgery.
- Manometer Group: Following intubation, the cuff pressure will be measured once using a manual manometer and adjusted to the 20-30 cmH₂O range. No further adjustments will be made unless clinically indicated.
- Control Group (Minimal Occlusive Volume): The cuff will be inflated using the "minimal occlusive volume" technique, wherein the cuff is inflated with the minimum volume of air required to prevent audible air leaks. No objective pressure gauge will be used.
Anesthesia Protocol: All patients will receive a standardized anesthesia protocol. Induction will be achieved with appropriate intravenous agents, and intubation will be performed by the same experienced anesthesiologist to ensure consistency. Anesthesia maintenance will be uniform across all groups. The study excludes patients with a history of difficult intubation, recent respiratory tract infections (within 6 months), preoperative sore throat/hoarseness, or operative times exceeding 3 hours.
Data Collection and Outcomes: The primary outcome is the incidence and severity of postoperative sore throat. Secondary outcomes include hoarseness, cough, dysphagia, laringospasm/bronchospasm, hemorrhage, and recovery times (extubation time, time to spontaneous respiration, and PACU stay duration).
Outcomes will be assessed at four specific time points:
- 0 hours (immediately post-extubation)
- 1 hour (in the Post-Anesthesia Care Unit - PACU)
- 12 hours (on the ward)
- 24 hours (postoperative day 1)
A four-point scale (0-3) will be used to grade symptoms (e.g., 0=None, 1=Mild, 2=Moderate, 3=Severe). To ensure blinding, the postoperative symptom assessment will be performed by a researcher who is unaware of the patient's group assignment.
Statistical Analysis: Sample size calculation indicated that 81 patients are required to detect a significant difference (effect size f=0.41, power=0.90, alpha=0.05), which was increased to 90 to account for a 10% dropout rate. Data will be analyzed using SPSS 26.0. Continuous variables will be analyzed using ANOVA or Kruskal-Wallis tests depending on normality, and categorical variables will be analyzed using Chi-square or Fisher's exact tests. Repeated measures (time-dependent changes) will be analyzed using the Friedman test.
- Being tested
- Continuous Cuff Pressure Indicator, Manual Cuff Pressure Manometer, Minimal Occlusive Volume Technique
- Keywords
- Continuous Cuff Pressure Monitoring, Manometer, Endotracheal Tube Cuff Pressure, Postoperative Sore Throat, Airway Complications, Intubation Safety
- Medical subject headings
- Hoarseness, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Cuff Pressure IndicatorDevice
Also called Continuous Cuff Pressure Controller
A device utilized to continuously monitor the endotracheal tube cuff pressure intraoperatively. It allows for real-time observation and maintenance of the pressure within the target range of 20-30 cmH₂O throughout the surgery.
Manual Cuff Pressure ManometerDevice
Also called Handheld Cuff Manometer
A standard analog manometer used for a single-time measurement of the endotracheal tube cuff pressure immediately after intubation. The pressure is adjusted to the standard range of 20-30 cmH₂O and not monitored continuously thereafter.
Minimal Occlusive Volume TechniqueProcedure or surgery
Also called Leak Test Method
A standard clinical technique where the endotracheal tube cuff is inflated with the minimum volume of air required to prevent audible air leakage during positive pressure ventilation. No objective pressure gauge is used for adjustment.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Pressure Indicator Group | Experimental | Patients in this group will have their endotracheal tube cuff pressure continuously monitored and maintained within the range of 20-30 cmH₂O using a continuous pressure indicator device throughout the surgery. Receives: Device: Continuous Cuff Pressure Indicator |
| Manometer Group | Active comparator | Patients in this group will have their endotracheal tube cuff pressure measured and adjusted once using a manual manometer immediately after intubation to a target range of 20-30 cmH₂O. Receives: Device: Manual Cuff Pressure Manometer |
| Control Group (Minimal Occlusive Volume) | Active comparator | Patients in this group will have their endotracheal tube cuff inflated using the minimal occlusive volume technique (inflating until the air leak stops) without the use of a pressure gauge. Receives: Procedure: Minimal Occlusive Volume Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Postoperative Sore Throat
Postoperative sore throat will be assessed using a 4-point categorical scale. The scoring is defined as follows: 0 = No sore throat; 1 = Mild sore throat (less than a cold); 2 = Moderate sore throat (similar to a cold); 3 = Severe sore throat (worse than a cold). Higher scores indicate a more severe adverse outcome.
Measured: 4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.
Secondary outcomes (9)
Incidence and Severity of Hoarseness
Assessed using a 4-point scale: 0 = None; 1 = Mild (minimal change in speech); 2 = Moderate (obvious hoarseness, communication not affected); 3 = Severe (affects communication)
Measured: 4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.
Incidence and Severity of Cough
Assessed using a 4-point scale: 0 = None; 1 = Mild (occasional); 2 = Moderate (frequent, disturbing); 3 = Severe (uncontrolled, constant, painful).
Measured: 4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.
Incidence and Severity of Dysphagia
Difficulty swallowing assessed using a 4-point scale: 0 = None; 1 = Mild (mild difficulty with solid foods); 2 = Moderate (obvious difficulty with solids and liquids); 3 = Severe (limits oral intake).
Measured: 4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.
Incidence of Laryngospasm or Bronchospasm
The presence (Yes) or absence (No) of laryngospasm or bronchospasm occurring during the extubation phase.
Measured: Up to 30 minutes following extubation.
Incidence of Airway Hemorrhage
Presence of blood on the endotracheal tube or in the airway immediately following extubation (Yes/No).
Measured: At the time of extubation
Extubation Time
The duration in minutes from the completion of the surgery to the removal of the endotracheal tube.
Measured: Up to 30 minutes following surgery completion.
Time to Spontaneous Respiration
The time in minutes from the discontinuation of anesthetic agents to the return of adequate spontaneous ventilation.
Measured: Up to 30 minutes following extubation.
Early Recovery Time
The time in minutes from extubation to the achievement of recovery criteria on the operating table (responding to verbal stimuli, head lift for 5 seconds, swallowing) prior to PACU transfer.
Measured: Up to 30 minutes following extubation.
Duration of Post-Anesthesia Care Unit (PACU) Stay
The total duration in minutes the patient remains in the recovery room until discharge criteria are met.
Measured: Up to 24 hours following extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study utilizes a parallel-group design with a 1:1:1 allocation ratio. Participants are randomized into three distinct arms: continuous pressure monitoring, intermittent manometer measurement, and a control group utilizing the minimal occlusive volume technique. The study employs a single-blind masking protocol wherein the outcomes assessor is blinded to the intervention assignment to minimize detection bias. This model is designed to compare the efficacy of objective versus subjective cuff pressure management strategies in preventing postoperative upper airway complications within a homogenous population of elective breast surgery patients.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Salih Tüzen, MD, Izmir Katip Celebi University
- Investigators
- Murat Aksun, M.D., Principal investigator, Izmir Katip Celebi University Atatürk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341646
- Sponsor's protocol ID
- 2025-KAEK-23
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data necessary to support the study protocol, including de-identified individual participant data (IPD) related to study protocol, and primary and secondary outcome measures, will be made available upon reasonable request from qualified researchers for academic purposes, in accordance with institutional and ethical guidelines.
Publications
Wang C, Yan X, Gao C, Liu S, Bao D, Zhang D, Jiang J, Wu A. Effect of continuous measurement and adjustment of endotracheal tube cuff pressure on postoperative sore throat in patients undergoing gynecological laparoscopic surgery: a randomized controlled trial. J Clin Monit Comput. 2024 Dec;38(6):1379-1386. doi: 10.1007/s10877-024-01173-y. Epub 2024 May 11.
PubMed 38733506Nwosu ADG, Ossai EN, Ejezie C, Obodo OC. Educational Intervention Can Improve the Pilot Balloon Palpation Method of Tracheal Tube Cuff Pressure Monitoring: An Experimental Study. J West Afr Coll Surg. 2025 Jan-Mar;15(1):53-58. doi: 10.4103/jwas.jwas_162_23. Epub 2024 Aug 2.
PubMed 39735817Maertens B, Blot K, Blot S. Prevention of Ventilator-Associated and Early Postoperative Pneumonia Through Tapered Endotracheal Tube Cuffs: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Crit Care Med. 2018 Feb;46(2):316-323. doi: 10.1097/CCM.0000000000002889.
PubMed 29206767Vasanth Karthik R, Ranganathan P, Kulkarni AP, Sharma KS. Does cuff pressure monitoring reduce postoperative pharyngolaryngeal adverse events after LMA-ProSeal insertion? A parallel group randomised trial. J Anesth. 2014 Oct;28(5):662-7. doi: 10.1007/s00540-014-1811-0. Epub 2014 Mar 19.
PubMed 24643810Choi HR, Kim S, Kim HJ, Ahn EJ, Kim KW, Bang SR. [Endotracheal tube cuff pressure increases in patients undergoing shoulder arthroscopy: a single cohort study]. Braz J Anesthesiol. 2020 Nov-Dec;70(6):583-587. doi: 10.1016/j.bjan.2020.04.021. Epub 2020 Nov 18.
PubMed 33279230El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.
PubMed 27158989
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Endotracheal Tube Cuff Pressure Assessment Methods on Postoperative Complications in Patients Undergoing Elective Breast Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07341646
- Acronym / sponsor ID
- 2025-KAEK-23
- Keywords
- Continuous Cuff Pressure Monitoring, Manometer, Endotracheal Tube Cuff Pressure, Postoperative Sore Throat, Airway Complications, Intubation Safety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 14 Jan 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.
Endotracheal intubation is a standard procedure used to secure the airway during general anesthesia. A key component of the breathing tube is the "cuff," a balloon-like device that is inflated to seal the airway and prevent aspiration. However, if the pressure within this cuff is too high, it can restrict blood flow to the tracheal lining, leading to complications such as postoperative sore throat, hoarseness, and difficulty swallowing (dysphagia).
Currently, there are various methods to monitor and adjust this pressure. In many clinical practices, the pressure is adjusted subjectively or checked only once at the beginning of the surgery. These methods may allow pressure to exceed safe limits (typically 20-30 cmH₂O) or fluctuate during the procedure, potentially causing tissue irritation. This randomized controlled trial aims to compare three different methods of assessing and maintaining endotracheal tube cuff pressure to determine which is most effective at reducing postoperative complications. The study focuses on women undergoing elective breast surgery, a group chosen because the surgery typically lasts 1-3 hours and does not involve major changes in head and neck position, allowing for a clear assessment of the cuff pressure methods.
Participants will be randomly assigned to one of three groups:
- Continuous Monitoring Group: Cuff pressure is monitored continuously using a pressure indicator and maintained within the 20-30 cmH₂O range throughout the surgery.
- Manometer Group: Cuff pressure is measured and set to 20-30 cmH₂O using a manual manometer once, immediately after intubation.
- Control Group (Minimal Occlusive Volume): The cuff is inflated with the minimum amount of air required to prevent an air leak, without using a pressure gauge.
Researchers will assess patients for sore throat, cough, hoarseness, and swallowing difficulties at 0, 1, 12, and 24 hours after surgery to identify the safest and most comfortable method for airway management.
Detailed description
This prospective, randomized, parallel-group, single-blind clinical trial investigates the efficacy of different endotracheal tube cuff pressure monitoring techniques in preventing postoperative airway morbidity. The study will be conducted at the İzmir Kâtip Çelebi University Atatürk Training and Research Hospital, Department of Anesthesiology and Reanimation.
The study population consists of female patients aged 18-65 years, classified as ASA I-III, who are scheduled for elective breast surgery under general anesthesia requiring endotracheal intubation. Breast surgery patients were selected as the target population because they represent a homogenous group (typically healthy females), undergo procedures of moderate duration (1-3 hours), and remain in a fixed supine position without significant head-neck manipulation, thereby minimizing confounding variables that could affect cuff pressure.
Study Procedures and Randomization: A total of 90 eligible patients will be enrolled. After providing informed consent, participants will be randomized into three groups with a 1:1:1 allocation ratio. Randomization will be performed using a computer-generated random sequence (via Research Randomizer, randomizer.org) to ensure unbiased assignment. The allocation sequence will be concealed from the investigators until the patient has been successfully intubated.
The three study arms are defined as follows:
- Continuous Pressure Indicator Group: Cuff pressure will be continuously monitored and maintained within the therapeutic range of 20-30 cmH₂O using a continuous pressure indicator device throughout the surgery.
- Manometer Group: Following intubation, the cuff pressure will be measured once using a manual manometer and adjusted to the 20-30 cmH₂O range. No further adjustments will be made unless clinically indicated.
- Control Group (Minimal Occlusive Volume): The cuff will be inflated using the "minimal occlusive volume" technique, wherein the cuff is inflated with the minimum volume of air required to prevent audible air leaks. No objective pressure gauge will be used.
Anesthesia Protocol: All patients will receive a standardized anesthesia protocol. Induction will be achieved with appropriate intravenous agents, and intubation will be performed by the same experienced anesthesiologist to ensure consistency. Anesthesia maintenance will be uniform across all groups. The study excludes patients with a history of difficult intubation, recent respiratory tract infections (within 6 months), preoperative sore throat/hoarseness, or operative times exceeding 3 hours.
Data Collection and Outcomes: The primary outcome is the incidence and severity of postoperative sore throat. Secondary outcomes include hoarseness, cough, dysphagia, laringospasm/bronchospasm, hemorrhage, and recovery times (extubation time, time to spontaneous respiration, and PACU stay duration).
Outcomes will be assessed at four specific time points:
- 0 hours (immediately post-extubation)
- 1 hour (in the Post-Anesthesia Care Unit - PACU)
- 12 hours (on the ward)
- 24 hours (postoperative day 1)
A four-point scale (0-3) will be used to grade symptoms (e.g., 0=None, 1=Mild, 2=Moderate, 3=Severe). To ensure blinding, the postoperative symptom assessment will be performed by a researcher who is unaware of the patient's group assignment.
Statistical Analysis: Sample size calculation indicated that 81 patients are required to detect a significant difference (effect size f=0.41, power=0.90, alpha=0.05), which was increased to 90 to account for a 10% dropout rate. Data will be analyzed using SPSS 26.0. Continuous variables will be analyzed using ANOVA or Kruskal-Wallis tests depending on normality, and categorical variables will be analyzed using Chi-square or Fisher's exact tests. Repeated measures (time-dependent changes) will be analyzed using the Friedman test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study utilizes a parallel-group design with a 1:1:1 allocation ratio. Participants are randomized into three distinct arms: continuous pressure monitoring, intermittent manometer measurement, and a control group utilizing the minimal occlusive volume technique. The study employs a single-blind masking protocol wherein the outcomes assessor is blinded to the intervention assignment to minimize detection bias. This model is designed to compare the efficacy of objective versus subjective cuff pressure management strategies in preventing postoperative upper airway complications within a homogenous population of elective breast surgery patients.
| Arm | Type | Receives |
|---|---|---|
| Continuous Pressure Indicator Group | Experimental | Device: Continuous Cuff Pressure IndicatorPatients in this group will have their endotracheal tube cuff pressure continuously monitored and maintained within the range of 20-30 cmH₂O using a continuous pressure indicator device throughout the surgery. |
| Manometer Group | Active comparator | Device: Manual Cuff Pressure ManometerPatients in this group will have their endotracheal tube cuff pressure measured and adjusted once using a manual manometer immediately after intubation to a target range of 20-30 cmH₂O. |
| Control Group (Minimal Occlusive Volume) | Active comparator | Procedure: Minimal Occlusive Volume TechniquePatients in this group will have their endotracheal tube cuff inflated using the minimal occlusive volume technique (inflating until the air leak stops) without the use of a pressure gauge. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged 18 to 65 years.
- Patients classified as American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Patients scheduled for elective breast surgery requiring general anesthesia and endotracheal intubation.
- Patients who provide voluntary written informed consent to participate.
Key exclusion criteria (6 listed)
- Patients with a history of Chronic Obstructive Pulmonary Disease (COPD) or an asthma attack within the last 6 months.
- Presence of preoperative sore throat, hoarseness, or cough.
- Patients with predicted difficult intubation or those who are difficult to intubate.
- Patients with communication difficulties that prevent accurate assessment of symptoms.
- Patients whose surgery duration exceeds 3 hours.
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 |
|---|---|---|
| Continuous Cuff Pressure IndicatorAlso: Continuous Cuff Pressure ControllerA device utilized to continuously monitor the endotracheal tube cuff pressure intraoperatively. It allows for real-time observation and maintenance of the pressure within the target range of 20-30 cmH₂O throughout the surgery. | Device | Continuous Pressure Indicator Group |
| Manual Cuff Pressure ManometerAlso: Handheld Cuff ManometerA standard analog manometer used for a single-time measurement of the endotracheal tube cuff pressure immediately after intubation. The pressure is adjusted to the standard range of 20-30 cmH₂O and not monitored continuously thereafter. | Device | Manometer Group |
| Minimal Occlusive Volume TechniqueAlso: Leak Test MethodA standard clinical technique where the endotracheal tube cuff is inflated with the minimum volume of air required to prevent audible air leakage during positive pressure ventilation. No objective pressure gauge is used for adjustment. | Procedure or surgery | Control Group (Minimal Occlusive Volume) |
Primary outcome
Incidence and Severity of Postoperative Sore Throat
Time frame: 4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.
Postoperative sore throat will be assessed using a 4-point categorical scale. The scoring is defined as follows: 0 = No sore throat; 1 = Mild sore throat (less than a cold); 2 = Moderate sore throat (similar to a cold); 3 = Severe sore throat (worse than a cold). Higher scores indicate a more severe adverse outcome.
9 secondary outcomes
Incidence and Severity of Hoarseness
Time frame: 4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.
Incidence and Severity of Cough
Time frame: 4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.
Incidence and Severity of Dysphagia
Time frame: 4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.
Incidence of Laryngospasm or Bronchospasm
Time frame: Up to 30 minutes following extubation.
Incidence of Airway Hemorrhage
Time frame: At the time of extubation
Extubation Time
Time frame: Up to 30 minutes following surgery completion.
Time to Spontaneous Respiration
Time frame: Up to 30 minutes following extubation.
Early Recovery Time
Time frame: Up to 30 minutes following extubation.
Duration of Post-Anesthesia Care Unit (PACU) Stay
Time frame: Up to 24 hours following extubation.
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 15 Jan 2026.
- Results publication: PubMed 38733506Wang C, Yan X, Gao C, Liu S, Bao D, Zhang D, Jiang J, Wu A. Effect of continuous measurement and adjustment of endotracheal tube cuff pressure on postoperative sore throat in patients undergoing gynecological laparoscopic surgery: a randomized controlled trial. J Clin Monit Comput. 2024 Dec;38(6):1379-1386. doi: 10.1007/s10877-024-01173-y. Epub 2024 May 11.
- Results publication: PubMed 39735817Nwosu ADG, Ossai EN, Ejezie C, Obodo OC. Educational Intervention Can Improve the Pilot Balloon Palpation Method of Tracheal Tube Cuff Pressure Monitoring: An Experimental Study. J West Afr Coll Surg. 2025 Jan-Mar;15(1):53-58. doi: 10.4103/jwas.jwas_162_23. Epub 2024 Aug 2.
- Results publication: PubMed 29206767Maertens B, Blot K, Blot S. Prevention of Ventilator-Associated and Early Postoperative Pneumonia Through Tapered Endotracheal Tube Cuffs: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Crit Care Med. 2018 Feb;46(2):316-323. doi: 10.1097/CCM.0000000000002889.
- Results publication: PubMed 24643810Vasanth Karthik R, Ranganathan P, Kulkarni AP, Sharma KS. Does cuff pressure monitoring reduce postoperative pharyngolaryngeal adverse events after LMA-ProSeal insertion? A parallel group randomised trial. J Anesth. 2014 Oct;28(5):662-7. doi: 10.1007/s00540-014-1811-0. Epub 2014 Mar 19.
- Results publication: PubMed 33279230Choi HR, Kim S, Kim HJ, Ahn EJ, Kim KW, Bang SR. [Endotracheal tube cuff pressure increases in patients undergoing shoulder arthroscopy: a single cohort study]. Braz J Anesthesiol. 2020 Nov-Dec;70(6):583-587. doi: 10.1016/j.bjan.2020.04.021. Epub 2020 Nov 18.
- Results publication: PubMed 27158989El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.
- Individual participant dataSharing planned: Undecided. All data necessary to support the study protocol, including de-identified individual participant data (IPD) related to study protocol, and primary and secondary outcome measures, will be made available upon reasonable request from qualified researchers for academic purposes, in accordance with institutional and ethical guidelines.
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Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
RecruitingObservational study
Comparison of Acute Airway/Respiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours
Extubation Failures, Extubation
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.
Murat Aksun, M.D. principal investigator
Izmir Katip Celebi University Atatürk Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Cuff Pressure Indicator, Manual Cuff Pressure Manometer and Minimal Occlusive Volume Technique in people with Airway Complications and Postoperative Sore Throat, run by Izmir Katip Celebi 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 6 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 15 Jan 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?
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?
Contact Murat Aksun, M.D. (+90 552 363 16 14, murataksun@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Postoperative Sore Throat (time frame: 4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07341646, which also lists 6 linked publications.
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 15 Jan 2026.