Airway Management and Weight in Children

Sponsor

University of Michigan (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03996343

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Perioperative Respiratory Adverse Events Airway Management	Device: Endotracheal intubation Device: Laryngeal mask airway	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

May 1, 2019

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endotracheal intubation	Device: Endotracheal intubation COMPLETE
Experimental: Laryngeal mask airway	Device: Laryngeal mask airway COMPLETE

Arm

Intervention/Treatment

Experimental: Endotracheal intubation

Device: Endotracheal intubation

COMPLETE

Experimental: Laryngeal mask airway

Device: Laryngeal mask airway

COMPLETE

Outcome Measures

Primary Outcome Measures

Severe respiratory adverse events [perioperative period]
laryngospasm, bronchospasm

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator: Olubukola Nafiu, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Olubukola Nafiu, Associate Professor of Anesthesiology, University of Michigan

ClinicalTrials.gov Identifier:

NCT03996343

Other Study ID Numbers:

HUM00132290

First Posted:

Jun 24, 2019

Last Update Posted:

Jun 24, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Olubukola Nafiu, Associate Professor of Anesthesiology, University of Michigan

Laryngeal mask airway

Endotracheal intubation

Obese

Study Results

No Results Posted as of Jun 24, 2019