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The Effect of Intraoperative Endotracheal Tube Cuff Pressure on Postoperative Sore Throat in Pediatric Patients Undergoing Laparoscopic Appendectomy: A Prospective Randomized Controlled Trial.

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
View:

• 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..

Locations
Other Locations
Turkey
Ankara Etlik City Hospital
RECRUITING
Ankara
Contact Information
Primary
Muhammed Yonucu, MD, Resident in Anesthesiology
harrenhal61@gmail.com
+905535222961
Time Frame
Start Date: 2026-06-30
Estimated Completion Date: 2026-08-25
Participants
Target number of participants: 60
Treatments
Active_comparator: Control Group
In this group of patients, endotracheal tube cuff pressure was adjusted using the traditionally used and subjective finger palpation technique of the endotracheal tube pilot balloon.
Experimental: Intervention Group
In this group of patients, endotracheal tube cuff pressure was continuously monitored using a pressure transducer from an invasive arterial pressure measurement set and maintained within a safe range (15-18 mmHg).
Sponsors
Leads: Ankara Etlik City Hospital

This content was sourced from clinicaltrials.gov

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