Effect of Cuff Pressure Assessment Methods on Postoperative Complications in Breast Surgery
NCT ID: NCT07341646
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2026-03-01
2027-06-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Continuous Pressure Indicator Group
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.
Continuous Cuff Pressure Indicator
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.
Manometer Group
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.
Manual Cuff Pressure 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.
Control Group (Minimal Occlusive Volume)
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.
Minimal Occlusive Volume Technique
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.
Interventions
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Continuous Cuff Pressure Indicator
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 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 Technique
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
FEMALE
No
Sponsors
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Izmir Katip Celebi University
OTHER
Responsible Party
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Ahmet Salih Tüzen, MD
Medical Doctor
Principal Investigators
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Murat Aksun, M.D.
Role: PRINCIPAL_INVESTIGATOR
Izmir Katip Celebi University Atatürk Training and Research Hospital
Locations
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Izmir Katip Celebi University Atatürk Training and Research Hospital
Izmir, Karabaglar, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Nwosu 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.
Maertens 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.
Vasanth 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.
Choi 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.
El-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.
Other Identifiers
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2025-KAEK-23
Identifier Type: -
Identifier Source: org_study_id
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