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Clinical Trials/NCT03996343
NCT03996343
Withdrawn
Not Applicable

Laryngeal Mask Airway Versus Endotracheal Intubation for Airway Management During General Anesthesia in Obese Children

University of Michigan1 site in 1 countryMay 2019

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Withdrawn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).

Registry
clinicaltrials.gov
Start Date
May 2019
End Date
June 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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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