NCT03996343
Withdrawn
Not Applicable
Laryngeal Mask Airway Versus Endotracheal Intubation for Airway Management During General Anesthesia in Obese Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Perioperative Respiratory Adverse Events
- Sponsor
- University of Michigan
- Locations
- 1
- Primary Endpoint
- Severe respiratory adverse events
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief Summary
The investigators in this study want to see how overweight/obese children who undergo elective surgery requiring airway management react to general anesthesia. They believe that the incidence of perioperative respiratory adverse events (PRAE) associated with Laryngeal mask airway (LMA) use during general anesthesia in overweight/obese children is lower than that associated with endotracheal intubation (ETT).
Investigators
Olubukola Nafiu
Associate Professor of Anesthesiology
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •sex-specific body mass index (BMI) is ≥85th percentile
- •elective surgical outpatient peripheral or lower abdominal procedures
- •Surgery length estimated to last between 30 and 120 minutes
Exclusion Criteria
- •Active gastro-esophageal reflux, possible difficult intubation or planned asleep fiber optic intubation, cardiac disease, thoracic deformities, upper abdominal, and thoracic or airway surgeries.
- •Children with active asthmatic attack or those considered to be "full stomach" will also be excluded.
- •Laparoscopic surgical procedures and those requiring extreme head-down tilt will also be excluded.
- •Children with a physiology or other condition requiring a certain type of airway for the procedure will also be excluded
- •Children whose anesthesiologist is not agreeable to randomization of airway management choice will also be excluded.
Outcomes
Primary Outcomes
Severe respiratory adverse events
Time Frame: perioperative period
laryngospasm, bronchospasm
Study Sites (1)
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