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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00674388
Other study ID # Wake up Safe
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2008
Est. completion date December 2025

Study information

Verified date November 2023
Source The Society for Pediatric Anesthesia
Contact Jayant K Deshpande, MD, MPH
Phone 8045656348
Email wakeupsafe@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The Study is designed to collect information about adverse events that occur in children undergoing anesthesia in participating hospitals. Demographic information will be collected on all anesthetics. An analysis of each adverse event will be performed and entered into the database. From this information we will devise strategies to prevent these adverse events.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000000
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 21 Years
Eligibility Inclusion Criteria: - All children undergoing anesthesia at participating hospitals Exclusion Criteria: - Patients over 21 years of age

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Akron Children's Hospital Akron Ohio
United States University of Michigan CS Mott Children's Hospital Ann Arbor Michigan
United States Emory Children's Center Atlanta Georgia
United States Colorado Children's Hospital Aurora Colorado
United States Dell Children's Medical Center of Central Texas Austin Texas
United States Johns Hopkins Childrens Center Baltimore Maryland
United States Children's Hospital Boston Boston Massachusetts
United States Womens and Childrens Hospital of Buffalo Buffalo New York
United States Medical University of South Carolina Charleston South Carolina
United States Children's Memorial Hospital Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Cleveland Clinic Children's Hospital Cleveland Ohio
United States Children's Medical Center Dallas Dallas Texas
United States Dayton Children's Hospital Dayton Ohio
United States Cook Children's Health Care System Fort Worth Texas
United States Penn State Hershey Children's Hospital Hershey Pennsylvania
United States Texas Children's Hospital Houston Texas
United States University of Iowa Stead Family Children's Hospital Iowa City Iowa
United States Arkansas Children's Hospital Little Rock Arkansas
United States Children's Hospital Los Angeles Los Angeles California
United States LeBonheur Children's Hospital Memphis Tennessee
United States St Jude Children's Research Hospital Memphis Tennessee
United States Monroe Carell Jr Children's Hospital at Venderbilt Nashville Tennessee
United States Children's Hospital at Montefiore New York New York
United States Morgan Stanley Children's Hospital New York New York
United States Oakland Medical Center Oakland California
United States Children's Hospital and Medical Center Omaha Nebraska
United States Arnold Palmer Children's Hospital Orlando Florida
United States Lucile Packard Children's Hospital Stanford Palo Alto California
United States The Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Phoenix Children's Hospital Phoenix Arizona
United States Pittsburgh Children's Hospital Pittsburgh Pennsylvania
United States SSM Cardinal Glennon Health Care System Saint Louis Missouri
United States All Children's Hospital Saint Petersburg Florida
United States Seattle Children's Hospital Seattle Washington
United States Children's National Health System Washington District of Columbia
United States Nemours/Alfred I duPont Hospital for Children Wilmington Delaware

Sponsors (40)

Lead Sponsor Collaborator
The Society for Pediatric Anesthesia Akron Children's Hospital, Alfred I. duPont Hospital for Children, Ann & Robert H Lurie Children's Hospital of Chicago, Arkansas Children's Hospital Research Institute, Arnold Palmer Hospital for Children, Baylor College of Medicine, Boston Children's Hospital, Children's Hospital and Medical Center, Omaha, Nebraska, Children's Hospital Colorado, Children's Hospital Los Angeles, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Children's Hospitals and Clinics of Minnesota, Children's Medical Center Dallas, Children's National Health System, Cleveland Clinic Children's Hospital, Cook Children's Health Care System, Dayton Children's Hospital, Dell Children's Medical Center of Central Texas, Emory-Children's Center, Johns Hopkins All Children's Hospital, Johns Hopkins University, Le Bonheur Children's Hospital, Lucile Packard Children's Hospital Stanford, Medical University of South Carolina, Monroe Carell Jr. Children's Hospital at Vanderbilt, Morgan Stanley Children's Hospital of New York, Oakland Medical Center, Penn State Hershey Children's Hospital, Phoenix Children's Hospital, Riley Children's Hospital, Seattle Children's Hospital, SSM Cardinal Glennon Children's Medical Center, St. Jude Children's Research Hospital, The Children's Hospital at Montefiore, University of Iowa Stead Family Children's Hospital, University of Michigan, University of Pittsburgh, Women & Children's Hospital of Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of adverse events 5 years
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