Actively Recruiting

Age: 2Years - 5Years
All Genders
ID07252674

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

Led by Konya City Hospital · Updated on 2026-06-03

100

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of two common airway management methods—Laryngeal Mask Airway (LMA) and Endotracheal Intubation (ETT)—in children aged 2 to 5 years undergoing elective surgery with general anesthesia. This study aims to compare how these methods influence intraoperative mechanical power, a measure linked to lung stress caused by ventilation. It also looks at postoperative respiratory problems such as cough, low oxygen levels, laryngospasm, bronchospasm, increased secretions, and breath-holding episodes. The study is observational, meaning the choice between LMA and ETT is made by the anesthesiologist based on clinical needs rather than randomly assigned. Mechanical power will be calculated using ventilator data collected at two times during surgery: immediately after airway placement and at surgery end before awakening. Postoperative respiratory complications will be recorded in the recovery unit. No additional procedures or changes to routine care will be made. Participants will undergo standard anesthesia with airway management by LMA or ETT as decided by their doctor. Mechanical power and respiratory outcomes will be monitored by different study team members to avoid bias. The research will include about 100 children, divided evenly between the two airway methods. The study will assess mechanical power during surgery and track respiratory complications until discharge from recovery, with no added interventions or follow-up beyond the immediate postoperative period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 2Years - 5Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 2 to 5 years
  • Body weight between 10 and 20 kilograms
  • Classified as ASA physical status I to III
  • Scheduled for elective surgery under general anesthesia
Not Eligible

You will not qualify if you...

  • Severe chronic lung disease such as advanced bronchopulmonary dysplasia
  • Uncontrolled or severe bronchial asthma
  • Severe cardiac failure classified as NYHA Class III or IV
  • Diagnosis of pulmonary hypertension
  • History of major lung surgery
  • Severe obesity with BMI above the 95th percentile
  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Surgery duration (up to 1 hour)

Participants undergo routine surgical procedures with airway management chosen by their anesthesiologist. Mechanical power is measured twice during surgery to assess the effects of airway devices without introducing additional interventions.

1 surgical visit (in-person)

Surveillance

Duration - Approximately 60 minutes

After surgery, participants are observed in the Post-Anesthesia Care Unit for up to approximately 60 minutes to monitor for respiratory complications.

1 post-operative visit (in-person)

Trial Site Locations

Total: 1 location

1

Konya City Hospital

Konya, Konya, Turkey (Türkiye)

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Research Team

E

Esma karaarslan, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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