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Airway Management and Weight in Children

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University of Michigan

Status

Withdrawn

Conditions

Airway Management
Perioperative Respiratory Adverse Events

Treatments

Device: Endotracheal intubation
Device: Laryngeal mask airway

Study type

Interventional

Funder types

Other

Identifiers

NCT03996343
HUM00132290

Details and patient eligibility

About

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).

Sex

All

Ages

2 to 17 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Endotracheal intubation
Experimental group
Treatment:
Device: Endotracheal intubation
Laryngeal mask airway
Experimental group
Treatment:
Device: Laryngeal mask airway

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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