Airway Management and Weight in Children

NCT03996343 | Withdrawn FDA Device

• 1 other identifier: HUM00132290
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Perioperative Respiratory Adverse Events; Airway Management

Keywords

Laryngeal mask airway; Endotracheal intubation; Obese

Outcome Measures

Primary Outcomes (1)

• Severe respiratory adverse events

  laryngospasm, bronchospasm

  perioperative period

Study Arms (2)

Endotracheal intubation

EXPERIMENTAL

Device: Endotracheal intubation

Laryngeal mask airway

EXPERIMENTAL

Device: Laryngeal mask airway

Interventions

Endotracheal intubation DEVICE

COMPLETE

Endotracheal intubation

Laryngeal mask airway DEVICE

COMPLETE

Laryngeal mask airway

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Intubation, Intratracheal; Laryngeal Masks

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Olubukola Nafiu, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 24, 2019
• Study Start: May 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 24, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)