Cuff pressure management during anesthesia for kids having laparoscopic appendectomy
Official title: The Effect of Intraoperative Endotracheal Tube Cuff Pressure on Postoperative Sore Throat in Pediatric Patients Undergoing Laparoscopic Appendectomy: A Prospective Randomized Controlled Trial.
Run by Ankara Etlik City Hospital · NCT07678086 · Data updated 2026-11-12
This study tests whether continuously measuring and keeping the breathing-tube cuff pressure in a safe range reduces sore throat and other airway symptoms in children after laparoscopic appendectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 18 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Ankara Etlik City Hospital Government |
| Locations | 1 site (Ankara, Yenimahalle) |
| Status | Recruiting |
| Started | June 30, 2026 |
| Main results expected | August 3, 2026 |
| Study ends | August 25, 2026 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT07678086 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–18 years scheduled for elective laparoscopic appendectomy, ASA I–III, with guardian consent.
✕Probably not a fit
Children with unusually short or long surgeries, airway anomalies, or intraoperative complications may not benefit from this cuff-pressure strategy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized trial compares two methods of managing endotracheal tube cuff pressure in pediatric patients undergoing laparoscopic appendectomy. Group A uses traditional finger palpation to adjust cuff pressure, while Group B uses a pressure transducer to continuously monitor and titrate pressure within a target range of 15-18 mmHg. The goal is to determine if objective monitoring reduces postoperative sore throat, cough, hoarseness, and airway-related complications compared with the conventional palpation method. Sixty children aged 6 to 18 years with ASA I–III are planned for inclusion. Outcomes focus on intraoperative respiratory mechanics and postoperative airway morbidities. The study is sponsored by Ankara Etlik City Hospital and conducted at that institution.
Why it matters
Potential benefit: If successful, real-time cuff pressure monitoring could lower postoperative airway complications and improve comfort for pediatric patients undergoing anesthesia.
How similar studies have gone: Prior evidence suggests objective cuff-pressure monitoring can improve airway outcomes, but pediatric data in this specific setting are limited and further validation is needed.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Ankara Etlik City Hospital
Ankara, Yenimahalle, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Muhammed Yonucu, MD, Resident in Anesthesiology
- Email: harrenhal61@gmail.com
- Phone: +905535222961
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.