Airway Management and Weight in Children

Not Applicable

Withdrawn

• Conditions: Perioperative Respiratory Adverse Events; Airway Management
• Interventions: Device: Endotracheal intubation; Device: Laryngeal mask airway

• Registration Number: NCT03996343
• Lead Sponsor: University of Michigan

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05
• Status Verified: 2019-06
• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-06-21
• Last Update Submitted: 2019-06-21
• Study First Posted: 2019-06-24
• Last Update Posted: 2019-06-24
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endotracheal intubation	Endotracheal intubation	-
Laryngeal mask airway	Laryngeal mask airway	-

Primary Outcome Measures

Name	Time	Method
Severe respiratory adverse events	perioperative period	laryngospasm, bronchospasm

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States