An interventional study of Continuous Cuff Pressure Indicator and Manual Cuff Pressure Manometer in Airway Complications, Postoperative Sore Throat and Hoarseness, sponsored by Izmir Katip Celebi University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Prevention
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:
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.
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:
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:
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.
52 studies on the registry are indexed under Hoarseness; 9 are open to participants now.
This study's enrollment of 90 is below the median of 108 across 44 interventional studies indexed under Hoarseness.
Browse Hoarseness studies →Izmir Katip Celebi University is the lead sponsor of 198 studies on the registry; 39 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Continuous Cuff Pressure Indicator
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.
Device: Manual Cuff Pressure Manometer
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.
Procedure: Minimal Occlusive Volume Technique
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.
Also known as: Continuous Cuff Pressure Controller
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.
Also known as: Handheld Cuff Manometer
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.
Also known as: Leak Test Method
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.
Time frame: 4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.
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)
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: At the time of extubation
Extubation Time
The duration in minutes from the completion of the surgery to the removal of the endotracheal tube.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 hours following extubation.
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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