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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Volume Versus Pressure Ventilation on Lung Atelectasis

NCT06076395

Cardiac Congenital Defects

ACTIVE_NOT_RECRUITING NA

A Method to Determine the Size of Laryngeal Mask Airway (LMA)

NCT02257411

Ear Based ProSeal LMA

COMPLETED NA

Laryngeal Mask Airway Supreme Versus Laryngeal Tube

NCT02252120

Adverse Anesthesia Outcome

COMPLETED NA

Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy

NCT01141660

Laryngeal Mask Airway Tonsillectomy

COMPLETED NA

LMA Placement Techniques and Airway in Children and Oropharyngeal Leak Pressure

NCT06174896

Anesthesia Airway

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mechanical Power

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1: LMA Group

Group 2: ETT Group

Laryngeal Mask Airway (LMA)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No