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Airway Management and Weight in Children

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ClinicalTrials.gov Identifier: NCT03996343
Recruitment Status : Withdrawn (Investigator leaving institution)
First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Olubukola Nafiu, 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).

Condition or disease Intervention/treatment Phase
Perioperative Respiratory Adverse Events Airway Management Device: Endotracheal intubation Device: Laryngeal mask airway Not Applicable

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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Endotracheal intubation Device: Endotracheal intubation
COMPLETE

Experimental: Laryngeal mask airway Device: Laryngeal mask airway
COMPLETE




Primary Outcome Measures :
  1. Severe respiratory adverse events [ Time Frame: perioperative period ]
    laryngospasm, bronchospasm



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996343


Locations
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United States, Michigan
The University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Olubukola Nafiu, MD University of Michigan

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Responsible Party: Olubukola Nafiu, Associate Professor of Anesthesiology, University of Michigan
ClinicalTrials.gov Identifier: NCT03996343     History of Changes
Other Study ID Numbers: HUM00132290
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Olubukola Nafiu, University of Michigan:
Laryngeal mask airway
Endotracheal intubation
Obese