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NCT03996343 Clinical Trial

Airway Management and Weight in Children

Airway Management Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03996343
Other study ID # HUM00132290
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date May 2019
Est. completion date June 2021

Study information
Verified date June 2019
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2021
Est. primary completion date June 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 17 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Endotracheal intubation
COMPLETE
• Laryngeal mask airway
COMPLETE

Locations
Country Name City State
United States The University of Michigan Ann Arbor Michigan

Sponsors (1)
Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Severe respiratory adverse events laryngospasm, bronchospasm perioperative period
See also
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