The Pediatric Anesthesia Quality Improvement Project | NCT00674388

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008Actual

Primary Completion Date

Dec 2035Estimated

Completion Date

Dec 2040Estimated

First Submitted Date

May 5, 2008

First Submission Date that Met QC Criteria

May 5, 2008

First Posted Date

May 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2025

Last Update Posted Date

May 21, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jayant K Deshpande, MD MPH, Executive Director, Wake up Safe, The Society for Pediatric AnesthesiaPrincipal Investigator

Lead Sponsor

The Society for Pediatric AnesthesiaOTHER

Collaborators

Name	Class
Children's Hospital Medical Center, Cincinnati	OTHER
Monroe Carell Jr. Children's Hospital at Vanderbilt	OTHER
Seattle Children's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000,000Estimated

Measure	Description	Time Frame
number of adverse events		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All children undergoing anesthesia at participating hospitals

Exclusion Criteria:

Patients over 21 years of age

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

All Children undergoing anesthesia at the participating hospitals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jayant K Deshpande, MD, MPH	Contact	8045656348		wakeupsafe@gmail.com
Anna Varughese, MD	Contact	7277672108		anna.varughese@jhmi.edu

Overall Officials

Name	Affiliation	Role
Jayant K Deshpande, MD MPH, MD	The Society for Pediatric Anesthesia	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Phoenix Children's Hospital	Recruiting	Phoenix	Arizona	85106	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.