The Performance of Pulse Oximeters in Pediatric Patients... | NCT00854048

Studies
The Performance of Pulse Oximeters in Pediatric Patients With Low Oxygen Saturation Levels

NCT00854048

Sponsor

Ulf Borg

Status

Completed

Last Update Posted

Nov 30, 2016Estimated

Enrollment

66Actual

Phase

Not provided

Conditions

Cardiopulmonary Bypass

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Feb 27, 2009

First Submission Date that Met QC Criteria

Feb 27, 2009

First Posted Date

Mar 2, 2009Estimated

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

Nov 29, 2016

Last Update Posted Date

Nov 30, 2016Estimated

Name	Class
Medtronic - MITG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Include pediatric patients with a baseline Sa02 < 90% and no contraindications to using an adhesive sensor.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pediatric patients after cardiopulmonary by-pass in the PICU.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xu Feng, MD	Children's Hospital Congqing Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chidren's Hospital		Chongqing University of Medical Sciences	Chongqing Municipality		China