Study of the: Effect of Head Rotation in Prone Position o... | NCT01760369

Studies
Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation.

NCT01760369

Sponsor

Glostrup University Hospital, Copenhagen

Status

Completed

Last Update Posted

Nov 14, 2013Estimated

Enrollment

52Actual

Phase

Not provided

Conditions

Regional Cerebral Oxygen Saturation During Head Rotation

Interventions

Not provided

Countries

Denmark

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

Jan 2013

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

Oct 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Dec 20, 2012

First Submission Date that Met QC Criteria

Jan 2, 2013

First Posted Date

Jan 4, 2013Estimated

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 13, 2013

Last Update Posted Date

Nov 14, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Johnny Andersen, Medical Doctor, Glostrup University Hospital, CopenhagenPrincipal Investigator

Lead Sponsor

Glostrup University Hospital, CopenhagenOTHER

Collaborators

Not provided

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 purpose of this study is to determine whether head rotation in prone positon affects regional cerebral oxygenation (rSO2)in anesthetized patients undergoing lower back surgery.

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

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

52Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in regional cerebral oxygenation (rSO2)	Before, during and immediately after awaking from anesthesia	1 day

Secondary Outcomes

Measure	Description	Time Frame
Post anesthetic complications	During stay at the post anesthetic care unit. Any new neurological symptoms, pain from the neck, visual symptoms etc.	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lower back surgery
Age [18-80]
ASA group I-III
free and painless movement of the neck (including flexion, extension and rotation)

Exclusion Criteria:

Pain during neck movement as mentioned under inclusion criteria.
known history of cervical spine pathology or pathology of central nervous system including cerebrovascular disease
any stenosis of the carotid vessels or known symptoms associated with such
BMI > 35

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing lowerback surgery under universal anesthesia at Glostrup Hospital, Copenhagen.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johnny DH Andersen, Doctor	Doctor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glostrup Hospital		Copenhagen	Glostrup kommune	2600	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24335413	Derived	Andersen JD, Baake G, Wiis JT, Olsen KS. Effect of head rotation during surgery in the prone position on regional cerebral oxygen saturation: A prospective controlled study. Eur J Anaesthesiol. 2014 Feb;31(2):98-103. doi: 10.1097/EJA.0000000000000028.