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NCT Number: NCT07678086

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

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.

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Key information

Conditions

Appendicitis Acute Airway Complications Appendicitis Cecal Diseases Cough Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Hoarseness Infections Intestinal Diseases Intraabdominal Infections Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Postoperative Sore Throat, Cough, Hoarseness Respiration Disorders Respiratory Complications Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Voice Disorders

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06010, Turkey (Türkiye)

Location status: Recruiting

Location contact

Muhammed Yonucu, MD, Resident in Anesthesiology

CONTACT

[email protected]

05535222961

About this study

Endotracheal tube (ETT) placement is a critical component of pediatric general anesthesia. In pediatric patients, the tracheal mucosa is highly sensitive to pressure. If the ETT cuff pressure exceeds the mucosal capillary perfusion pressure, it can lead to ischemic damage and subsequent postoperative airway morbidities such as postoperative sore throat (POST), cough, and hoarseness.

During laparoscopic surgeries such as appendectomy, the creation of pneumoperitoneum and the necessary surgical positioning increase intra-abdominal and intrathoracic pressures. These physiological changes dynamically increase the peak airway pressure (Ppeak) and the corresponding ETT cuff pressure, making optimal cuff pressure management clinically challenging.

Traditionally, cuff pressure is subjectively adjusted by the anesthesiologist using a pilot balloon palpation technique. However, evidence suggests that this method often leads to undetectable and unsafe high pressures. Alternatively, continuous objective monitoring of endotracheal tube (ETT) cuff pressure using an invasive arterial blood pressure transducer setup offers a real-time method for maintaining pressure within a safe physiological range (15-18 mmHg).

This prospective, randomized controlled trial aims to investigate whether continuous objective monitoring and titration of ETT cuff pressure via a pressure transducer, compared to conventional subjective palpation, can optimize intraoperative respiratory mechanics and reduce the frequency and severity of postoperative upper respiratory tract complications in pediatric patients undergoing laparoscopic appendectomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Invasive blood pressure monitoring set, Continuous cuff pressure monitoring

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.

Other names: Manual cuff pressure estimation, Pilot balloon palpation, Subjective cuff inflation, Standard clinical cuff management

Primary outcomes

  1. Incidence of Postoperative Sore Throat

    Time frame: 24 hours postoperatively

    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.

Secondary outcomes

  1. Incidence of postoperative hoarseness.

    Time frame: 24 hours postoperatively

    The frequency of hoarseness will be assessed and compared between groups within the first 24 hours after surgery.

    Hoarseness will be defined as an abnormal change in the voice, such as the voice sounding breathy, muffled, strained, or a change in loudness or pitch.

    It will be evaluated as yes/no.

  2. Intraoperative highest inspiratory pressure (Ppeak)

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

    The highest inspiratory pressure (Ppeak) (mmHg) measured after intubation (T0), after pneumoperitoneum (T1), and every 15 minutes (T1+15 min=T2, T2+15 min=T3), after abdominal desufflation (Td), and before extubation (Te) will be recorded and compared between groups.

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

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

    Assessment of the presence and severity of sore throat after extubation. Severity is scored using a 4-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Comparisons will be made between groups after the assessment.

  4. Frequency of Cough at Specific Time Points Postoperatively

    Time frame: Measured at 2, 6, and 24 hours post-extubation

    Postoperative cough will be assessed and compared between groups 2, 6, and 24 hours after discontinuation of intubation. It will be evaluated as yes/no.

  5. Incidence of postoperative cough

    Time frame: 24 hours postoperatively

    The frequency of cough will be assessed and compared between groups within the first 24 hours after surgery.

    It will be evaluated as yes/no.

  6. Incidence of postoperative stridor

    Time frame: 24 hours postoperatively

    The frequency of stridor will be assessed and compared between groups within the first 24 hours after surgery.

    In a situation where the patient is pain-free (calm), airway secretions are completely cleared, and there is no anatomical/residual airway obstruction, a new, high-pitched inspiratory sound that occurs after extubation will be considered stridor.

    It will be evaluated as yes/no.

  7. Frequency of Hoarseness at Specific Time Points Postoperatively

    Time frame: Measured at 2, 6, and 24 hours post-extubation

    Postoperative hoarseness will be assessed and compared between groups 2, 6, and 24 hours after discontinuation of intubation.

    It will be evaluated as yes/no. Hoarseness will be defined as an abnormal change in the voice, such as the voice sounding breathy, muffled, strained, or a change in loudness or pitch.

  8. Frequency of Stridor at Specific Time Points Postoperatively

    Time frame: Measured at 2, 6, and 24 hours post-extubation

    Postoperative stridor will be assessed and compared between groups 2, 6, and 24 hours after discontinuation of intubation.

    It will be evaluated as yes/no. In a situation where the patient is pain-free (calm), airway secretions are completely cleared, and there is no anatomical/residual airway obstruction, a new, high-pitched inspiratory sound that occurs after extubation will be considered stridor.

  9. Intraoperative End-tidal carbon dioxide (EtCO2)

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

    End-tidal carbon dioxide (EtCO2) (mmHg) will be recorded and compared between groups after intubation (T0), after pneumoperitoneum (T1), every 15 minutes (T1+15 min=T2, T2+15 min=T3), after abdominal desufflation (Td), and before extubation (Te).

  10. Intraoperative Leak minute ventilation (MVleak)

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

    Leak minute ventilation (MVleak) (L/minute) values will be recorded and compared between groups after intubation (T0), after pneumoperitoneum (T1), every 15 minutes (T1+15 min=T2, T2+15 min=T3), after abdominal desufflation (Td), and before extubation (Te).

  11. Intraoperative Tidal volume

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

    Tidal volume (ml) values will be recorded and compared between groups after intubation (T0), after pneumoperitoneum (T1), every 15 minutes (T1+15 min=T2, T2+15 min=T3), after abdominal desufflation (Td), and before extubation (Te).

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammed Yonucu, MD, Resident in Anesthesiology

CONTACT

[email protected]

+905535222961

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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