Accuracy of pilot balloon palpation for cuff pressure assessment in small versus large sized tubes: a prospective non-randomized observational study.
Min Gi Ban, So Yeon Kim, Min Soo Kim...
https://pubmed.ncbi.nlm.nih.gov/37020098/Actively Recruiting
Led by Ankara Etlik City Hospital · Updated on 2026-07-07
60
Participants Needed
1
Research Sites
3 weeks
Total Duration
Researchers are evaluating two methods of adjusting the air-filled cushion cuff of the breathing tube used during general anesthesia in children aged 6 to 18 years undergoing laparoscopic appendectomy for appendicitis. The study aims to determine if maintaining the cuff pressure within a specific safe range 15-18 mmHg helps reduce common postoperative issues such as sore throat, hoarseness, and respiratory discomfort. This is a prospective, randomized, controlled trial comparing a standard subjective method with continuous objective monitoring. Participants are randomly assigned to one of two groups. The control group has the cuff pressure adjusted by the anesthesiologist using the traditional finger palpation method. The intervention group has the cuff pressure continuously monitored throughout surgery using a pressure transducer device, maintaining the pressure within the safe range. Respiratory and heart rate measurements are recorded every 15 minutes during the procedure, which lasts approximately 30 to 120 minutes. After surgery, researchers assess participants at 2, 6, and 24 hours postoperatively for sore throat, hoarseness, cough, stridor, and respiratory discomfort. Data collected include intraoperative airway pressures, ventilation parameters, and postoperative symptom frequency and severity. The primary outcome is the incidence of postoperative sore throat at 24 hours. Participation involves monitoring during surgery and follow-up assessments for one day after surgery.
CONDITIONS
Effect of Endotracheal Tube Cuff Pressure Management on Postoperative Sore Throat in Pediatric Laparoscopic Appendectomy
M
Muhammed Yonucu, MD, Resident in Anesthesiology
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Ankara Etlik City Hospital
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 30 to 120 minutes
Participants undergo laparoscopic appendectomy under general anesthesia. During surgery, breathing tube cuff pressure is managed either by traditional manual palpation or by continuous monitoring using a pressure transducer device to maintain safe pressure levels.
Respiratory and heart rate measurements every 15 minutes during surgery
Duration - 24 hours post-surgery
Researchers assess participants at 2, 6, and 24 hours after surgery to check for sore throat, hoarseness, cough, stridor, and other respiratory symptoms.
Assessments at 3 time points postoperatively
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/31728125/Ankara Etlik City Hospital
Lead Sponsor