NCT07678086 Effect of Endotracheal Tube Cuff Pressure Management on Postoperative Sore Throat in Pediatric Laparoscopic Appendectomy
| NCT ID | NCT07678086 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ankara Etlik City Hospital |
| Condition | Appendicitis Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-06-30 |
| Primary Completion | 2026-08-03 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-06-30 with a primary completion date of 2026-08-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07678086 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Appendicitis Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07678086 currently recruiting?
Yes, NCT07678086 is actively recruiting participants. Contact the research team at harrenhal61@gmail.com for enrollment information.
Where is the NCT07678086 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07678086 clinical trial?
NCT07678086 is sponsored by Ankara Etlik City Hospital. The trial plans to enroll 60 participants.