Effect of Endotracheal Tube Cuff Pressure Management on Postoperative Sore Throat in Pediatric La… (NCT07678086) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Endotracheal Tube Cuff Pressure Management on Postoperative Sore Throat in Pediatric Laparoscopic Appendectomy
Turkey (Türkiye)60 participantsStarted 2026-06-30
Plain-language summary
Abstract Objective:
The aim of this study is to compare two different ways of adjusting the air-filled cushion (cuff) of the breathing tube used during general anesthesia in children undergoing laparoscopic appendectomy (closed surgery for appendicitis). The goal is to see if maintaining the pressure in this cushion within a safe, specific range (15-18 mmHg) helps prevent or reduce sore throat, hoarseness, and discomfort, which are common postoperative complications in children.
Study Design:
This is a prospective, randomized, controlled study. Sixty children aged 6 to 18 years scheduled for laparoscopic appendectomy will be included. Participants will be randomly assigned to two equal groups: Group A (Control Group): Breathing tube cuff pressure is adjusted using the standard "feeling" (finger palpation) method common in routine practice. Group B (Intervention Group): Breathing tube cuff pressure is measured throughout the surgery using a medical pressure sensor (manometer) and maintained within a safe range (15-18 mmHg). Research Questions: Does actively monitoring airway pressure reduce the number of children experiencing postoperative sore throat? Does this method reduce the severity of sore throat, cough, hoarseness, or other respiratory discomfort compared to the standard method? What will happen?
During surgery, respiratory and heart rate measurements will be recorded every 15 minutes for all participants. After surgery, researchers will visit participants (and their parents) at 2, 6, and 24 hours postoperatively to assess the presence of sore throat, discomfort, or hoarseness. No additional medications or invasive procedures will be used for this study; only how we manage airway pressure will be compared.
Who can participate
Age range
6 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pediatric patients aged 6-18 years
* Patients with ASA physical status classification I-III
* Patients scheduled for laparoscopic appendectomy
* Voluntary written informed consent from the patient's legal guardian/parent after being informed in detail about the purpose and method of the study..
Exclusion Criteria:
* Patients under 6 years of age
* Patients with ASA IV or higher
* Patients with preoperative sore throat
* Patients who have not completed the preoperative fasting period
* Patients who received intraoperative nasogastric tube
* Patients who received intraoperative N₂O
* Patients with complicated appendicitis diagnosis
* Patients who underwent two or more intubation attempts
* Patients with surgery duration longer than 2 hours
* Patients with predicted or likely airway difficulties
* Patients who underwent conversion from intraoperative laparoscopy to laparotomy
* Presence of tracheal pathology
* Congenital anomalies affecting the airway
* Presence of known upper/lower respiratory tract disease
* Patients requiring planned postoperative mechanical ventilation
* Patients in shock
* Patients with decompensated heart failure or respiratory failure
* Patient or legal representative's refusal to participate in the study
* Patients with a history of smoking
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.