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Recruiting NCT07252674

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

Conditions: Mechanical Power

Sponsor: Konya City Hospital

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Interventions
Laryngeal Mask Airway (LMA)
PROCEDURE
Locations 1
Turkey (1)
Konya City Hospital
Konya , Konya
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
2 Years
Maximum age
5 Years
Healthy volunteers
No
Start date
30.11.2025
Completion date
30.05.2026
Registry ID
NCT07252674
Source
clinicaltrials.gov
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