Skip to content

Airway Management and Weight in Children

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03996343
Enrollment
0
Registered
2019-06-24
Start date
2019-05-31
Completion date
2021-06-30
Last updated
2019-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management, Perioperative Respiratory Adverse Events

Keywords

Laryngeal mask airway, Endotracheal intubation, Obese

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).

Interventions

DEVICEEndotracheal intubation

COMPLETE

DEVICELaryngeal mask airway

COMPLETE

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Severe respiratory adverse eventsperioperative periodlaryngospasm, bronchospasm

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026