Effect of Endotracheal Tube Cuff Pressure Management on Postoperative Sore Throat in Pediatric Laparoscopic Appendectomy

NCT07678086 | Recruiting

• 1 other identifier: AEŞH-EK-2026-037
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis Acute; Postoperative Sore Throat, Cough, Hoarseness; Airway Complications; Respiratory Complications

Keywords

Endotracheal tube cuff pressure; Post-anesthetic complications; Pressure transducer; Laparoscopic appendectomy; Pediatric anesthesia; Airway management; postoperative sore throat

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Sore Throat

  The incidence of sore throat in patients during the first 24 hours after surgery will be evaluated and compared between groups. Sore throat is defined as pain or discomfort felt in the larynx or pharynx, often worsened by swallowing. It will be evaluated as yes/no.

  24 hours postoperatively

Secondary Outcomes (11)

• Incidence of postoperative hoarseness.

  24 hours postoperatively

• Intraoperative highest inspiratory pressure (Ppeak)

  Throughout the duration of the surgical procedure (approx. 30-120 minutes)

• Frequency and severity of postoperative sore throat according to postoperative time.

  Measured at 2, 6, and 24 hours post-extubation.

• Frequency of Cough at Specific Time Points Postoperatively

  Measured at 2, 6, and 24 hours post-extubation

• Incidence of postoperative cough

  24 hours postoperatively

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Procedure: Traditional Palpation Method

Intervention Group

EXPERIMENTAL

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).

Device: Pressure Transducer

Interventions

Pressure Transducer DEVICE

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).

Also known as: Invasive blood pressure monitoring set, Continuous cuff pressure monitoring

Intervention Group

Traditional Palpation Method PROCEDURE

The endotracheal tube cuff pressure was adjusted by the anesthesiologist using the subjective manual palpation technique, where the pressure in the cuff was estimated by manually squeezing the pilot balloon. No external monitoring device was used in this group, reflecting the conventional clinical practice.

Also known as: Manual cuff pressure estimation, Pilot balloon palpation, Subjective cuff inflation, Standard clinical cuff management

Control Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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..

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06010, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Ban MG, Kim SY, Kim MS, Park WK, Kwon YI, Kim HJ. Accuracy of pilot balloon palpation for cuff pressure assessment in small versus large sized tubes: a prospective non-randomized observational study. Sci Rep. 2023 Apr 5;13(1):5580. doi: 10.1038/s41598-023-32704-3.

  PMID: 37020098 BACKGROUND

• Ganason N, Sivanaser V, Liu CY, Maaya M, Ooi JSM. Post-operative Sore Throat: Comparing the Monitored Endotracheal Tube Cuff Pressure and Pilot Balloon Palpation Methods. Malays J Med Sci. 2019 Sep;26(5):132-138. doi: 10.21315/mjms2019.26.5.12. Epub 2019 Nov 4.

  PMID: 31728125 BACKGROUND

• Liu J, Zhang X, Gong W, Li S, Wang F, Fu S, Zhang M, Hang Y. Correlations between controlled endotracheal tube cuff pressure and postprocedural complications: a multicenter study. Anesth Analg. 2010 Nov;111(5):1133-7. doi: 10.1213/ANE.0b013e3181f2ecc7. Epub 2010 Aug 24.

  PMID: 20736432 BACKGROUND

• Wang C, Yan X, Gao C, Liu S, Bao D, Zhang D, Jiang J, Wu A. Effect of continuous measurement and adjustment of endotracheal tube cuff pressure on postoperative sore throat in patients undergoing gynecological laparoscopic surgery: a randomized controlled trial. J Clin Monit Comput. 2024 Dec;38(6):1379-1386. doi: 10.1007/s10877-024-01173-y. Epub 2024 May 11.

  PMID: 38733506 BACKGROUND

MeSH Terms

Conditions

Appendicitis; Cough; Hoarseness

Interventions

Transducers, Pressure

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Voice Disorders; Laryngeal Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Transducers; Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Muhammed Yonucu, MD, Resident in Anesthesiology

CONTACT

+905535222961; harrenhal61@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study employs a single-blind design. The attending anesthesiologist performing the intraoperative procedure and data collection is aware of the group assignment (unmasked) to ensure correct intervention and monitoring. The principal investigator, who conducts all postoperative follow-up assessments, including sore throat scoring and airway complication evaluations, remains blinded to the patient's group allocation (masked) to prevent observer bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Model Details: This study has a parallel-group, prospective, randomized, controlled design. Patients undergoing laparoscopic appendectomy are assigned to groups in a 1:1 ratio by drawing numbers from a opaque bag containing numbers from 1 to 60. Odd numbers are assigned to Group A, where endotracheal tube (ETT) cuff pressure is adjusted by subjective palpation. Even numbers are assigned to Group B, where ETT cuff pressure is objectively monitored via a pressure transducer and maintained within a safe range (15-18 mmHg). Participants remain in their assigned groups for the entire intraoperative and postoperative follow-up period. Patients who meet pre-defined exclusion criteria during surgery (such as conversion to laparotomy, complicated appendicitis, or procedure duration exceeding 2 hours) are removed from the study, and their assigned numbers are re-randomized. All patients follow the same standardized anesthesia and surgical protocol; the only difference is the method of cuff pressure management.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 1, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): August 3, 2026
• Study Completion (Estimated): August 25, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)