Airway Management and Weight in Children

NCT ID: NCT03996343

Last Updated: 2019-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-31

Study Completion Date

2021-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Perioperative Respiratory Adverse Events Airway Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Endotracheal intubation

Group Type EXPERIMENTAL

Endotracheal intubation

Intervention Type DEVICE

COMPLETE

Laryngeal mask airway

Group Type EXPERIMENTAL

Laryngeal mask airway

Intervention Type DEVICE

COMPLETE

Interventions

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Endotracheal intubation

COMPLETE

Intervention Type DEVICE

Laryngeal mask airway

COMPLETE

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Olubukola Nafiu

Associate Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olubukola Nafiu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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The University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00132290

Identifier Type: -

Identifier Source: org_study_id

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