Effect of Cuff Pressure Assessment Methods on Postoperative Complications in Breast Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorIzmir Katip Celebi University
About this 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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous Cuff Pressure Indicator
DeviceA 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
DeviceA 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
Procedure/SurgeryA 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Continuous Pressure Indicator GroupExperimental treatment 1 intervention
Group B: Manometer GroupActive comparator 1 intervention
Group C: Control Group (Minimal Occlusive Volume)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov
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