Normal Values of Brain Oxygenation | NCT00512447

Studies
Normal Values of Brain Oxygenation

NCT00512447

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Sep 14, 2010Estimated

Enrollment

171Actual

Phase

Not provided

Conditions

Cerebral Arterial Disease

Interventions

Not provided

Countries

Switzerland

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

Sep 2010

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

Jul 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 6, 2007

First Submission Date that Met QC Criteria

Aug 6, 2007

First Posted Date

Aug 7, 2007Estimated

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

Sep 13, 2010

Last Update Posted Date

Sep 14, 2010Estimated

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

New technology allows non-invasive monitoring of brain oxygenation (Near-Infrared-Spectroscopy). However, there are no large series of normal values in various adult age groups. We hypothesised that baseline values in patients breathing room air are lower in old patients than in younger subjects and that younger patients respond increase their brain oxygenation more in response to supplemental oxygen.

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

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

171Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 25 and 95 years undergoing a elective surgical procedure

Exclusion Criteria:

History of cerebral disease
Dependence on supplemental oxygen

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing elective surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luzius A Steiner, MD, PhD	Department of Anaesthesia, University Hospital Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesia, University Hospital Basel		Basel	Canton of Basel-City	4031	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D002539	Cerebral Arterial Diseases

Ancestor Terms

ID	Term
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided