Comparison of Laryngeal Mask Airway and Endotracheal Intubation on Mechanical Power in Pediatric Patients (LMA-MP)

Impact of Laryngeal Mask Airway Versus Endotracheal Intubation on Mechanical Power and Postoperative Respiratory Complications in Pediatric Patients: A Prospective Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Power
• Intervention / Treatment: Procedure: Laryngeal Mask Airway (LMA)

Detailed Description

This prospective, observational, single-center clinical study will be conducted in the Department of Anesthesiology and Reanimation at Konya City Hospital. The aim of the study is to compare the effects of Laryngeal Mask Airway (LMA) and Endotracheal Intubation (ETT) on intraoperative mechanical power in pediatric patients aged 2-5 years undergoing elective surgical procedures under general anesthesia. Mechanical power, calculated from routinely measured ventilator parameters, reflects the energy delivered to the respiratory system and is considered an important marker of ventilator-induced lung injury. Understanding how different airway devices influence mechanical power may contribute to improving lung-protective ventilation strategies in pediatric anesthesia.

Randomization will not be applied in this study. Airway management (LMA or ETT) will be chosen solely by the attending anesthesiologist based on clinical needs, including procedure type, expected duration, and aspiration risk. A standardized anesthesia induction and maintenance protocol will be applied to all patients. Mechanical power will be measured at two time points: (1) immediately after securing the airway and (2) at the end of surgery before emergence. Postoperative respiratory complications-including cough, hypoxemia, laryngospasm, bronchospasm, increased secretions, and breath-holding-will be systematically recorded in the Post-Anesthesia Care Unit (PACU).

To minimize observer bias, intraoperative mechanical power measurements and postoperative complication assessments will be performed by different members of the research team. No deviations from routine clinical practice will occur, and no additional interventions will be introduced. Based on the power analysis for the primary outcome, the study aims to include a total of 100 pediatric patients, with 50 patients in the LMA group and 50 patients in the ETT group.

The findings of this research are expected to provide new insights into the effects of different airway devices on mechanical power and to support the development of lung-protective anesthesia strategies in pediatric patients.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Esma karaarslan, MD; Phone Number: +905057317061; Email: esmaayvaz@gmail.com

Study Locations

• Turkey (Türkiye)
  • Konya
    • Konya, Konya, Turkey (Türkiye)
      • Recruiting
      • Konya City Hospital
      • Contact: Esma Karaarslan, MD; Phone Number: +90 505 731 7061; Email: esmaayvaz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Group 1: LMA Group; Group 2: ETT Group

Procedure: Laryngeal Mask Airway (LMA); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Respiratory Complications	Respiratory complications observed during the emergence period and in the Post-Anesthesia Care Unit (PACU), including cough, breath holding, laryngospasm, bronchospasm, increased secretions, and oxygen desaturation, will be systematically recorded.	From the start of emergence until discharge from PACU (assessed up to approximately 60 minutes).

Collaborators and Investigators

• Sponsor: Konya City Hospital
• Investigators: Principal Investigator: Esma Karaarslan, MD, Konya City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Laryngeal Mask Airway; Mechanical Power; Endotracheal Intubation; Postoperative Respiratory Complications
• Additional Relevant MeSH Terms: Investigative Techniques; Therapeutics; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture; Airway Management; Protective Devices; Personal Protective Equipment; Intubation, Intratracheal; Intubation; Masks; Laryngeal Masks
• Other Study ID Numbers: LMA-MP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If data sharing is approved by the research team in the future, anonymized individual participant data (IPD) may be shared with qualified researchers upon reasonable request. Any shared data would exclude identifying information and would include only demographic variables and study-related measurements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No