Comparison of Laryngeal Mask Airway and Endotracheal Intubation on Mechanical Power in Pediatric Patients

NCT07252674 | Recruiting

• 1 other identifier: LMA-MP
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study aims to compare two commonly used airway management methods-Laryngeal Mask Airway (LMA) and Endotracheal Intubation (ETT)-in pediatric patients undergoing elective surgery under general anesthesia. The primary objective is to evaluate the impact of LMA and ETT on intraoperative mechanical power, an emerging indicator of ventilator-induced lung stress. Secondary objectives include assessing postoperative respiratory complications such as cough, hypoxemia, laryngospasm, bronchospasm, increased secretions, and breath-holding episodes. No interventions will be assigned based on a study protocol; airway management will be determined solely by clinical requirements. Routine ventilator parameters will be recorded, and mechanical power will be calculated using a validated simplified formula.

Conditions

Mechanical Power

Keywords

Mechanical Power; Laryngeal Mask Airway; Endotracheal Intubation; Postoperative Respiratory Complications

Outcome Measures

Primary Outcomes (1)

• Mechanical power (MP)

  To compare the effects of laryngeal mask airway (LMA) and endotracheal intubation (ETT) on intraoperative mechanical power (MP) in pediatric patients aged 2-5 years undergoing elective surgery under general anesthesia. Mechanical power (MP) will be assessed using ventilator-derived respiratory parameters (tidal volume, respiratory rate, PEEP, peak pressure, and plateau pressure). MP will be calculated using the following validated equation: Mechanical Power (J/min) = 0.098 × RR × VT × (PEEP + ½(Pplat - PEEP) + (Ppeak - Pplat)).

  Mechanical power will be measured twice during surgery, as follows: MP1: Immediately after airway placement, before the start of surgery. MP2: At the end of surgery, before the initiation of emergence.

Secondary Outcomes (1)

• Postoperative Respiratory Complications

  From the start of emergence until discharge from PACU (assessed up to approximately 60 minutes).

Study Arms (1)

Group 1: LMA Group

Group 2: ETT Group

Procedure: Laryngeal Mask Airway (LMA)

Interventions

Laryngeal Mask Airway (LMA) PROCEDURE

Randomization is not applied in this study. Since the research is observational in nature, the allocation of patients to the LMA or ETT groups is not performed randomly; instead, it is determined by the attending anesthesiologist based on the type of surgery, clinical requirements, and the individual characteristics of the patient. Accordingly, the choice of airway management method is not influenced by the investigators; the treatment process proceeds according to routine clinical practice, prioritizing patient safety and established clinical standards. Group 1: LMA Group Description: This cohort consists of pediatric patients in whom a Laryngeal Mask Airway (LMA) is used for airway management during surgery. Group 2: ETT Group Description: This cohort consists of pediatric patients who undergo Endotracheal Intubation (ETT) for airway management during surgery.

Group 1: LMA Group

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of pediatric patients aged 2-5 years and weighing 10-20 kg who will undergo elective surgery under general anesthesia at Konya City Hospital. Participants will be classified as ASA physical status I-III. Patients who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study.

You may qualify if:

• Children aged 2-5 years
• Body weight between 10-20 kg
• Patients classified as ASA physical status I-III
• Elective surgery planned under general anesthesia

You may not qualify if:

• Presence of severe chronic lung disease (e.g., advanced bronchopulmonary dysplasia)
• Uncontrolled or severe bronchial asthma
• Severe cardiac failure (NYHA Class III-IV)
• Diagnosis of pulmonary hypertension
• History of major lung surgery
• Severe obesity (BMI \> 95th percentile)
• Children scheduled for abdominal or thoracic surgery
• Procedures expected to last longer than one hour
• Emergency surgeries
• Children and/or parents who decline participation in the study

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, Konya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Esma Karaarslan, MD

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esma karaarslan, MD

CONTACT

+905057317061; esmaayvaz@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor (MD), Department of Anesthesiology and Reanimation, Konya City Hospital

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 28, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

TU (1)