Measuring the Effect of External Pressure on the Regional... | NCT01971996

Studies
Measuring the Effect of External Pressure on the Regional Cerebral Oxygen Saturation Monitored by Near-infrared Spectroscopy(NIRS) Technology

NCT01971996

Sponsor

Glostrup University Hospital, Copenhagen

Status

Completed

Last Update Posted

Jul 2, 2014Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Anaesthesia

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

Jul 2014

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

Nov 2013

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Oct 24, 2013

First Submission Date that Met QC Criteria

Oct 24, 2013

First Posted Date

Oct 30, 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

Jul 1, 2014

Last Update Posted Date

Jul 2, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Johnny Andersen, M.D., Glostrup University Hospital, CopenhagenPrincipal Investigator

Lead Sponsor

Glostrup University Hospital, CopenhagenOTHER

Collaborators

Not provided

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

Description Module

Brief Summary

During general anaesthesia, to ensure sufficient oxygen supply to the brain, the NIRS technology can be used. It consist of two sensors placed on the forehead, and measures the oxygen saturation of the tissue underneath the sensor. For patients undergoing back surgery placed in the prone position, the NIRS measurement will be affected, because the weight of the head will produce a pressure on the sensors. We wish to investigate how much the measurement is affected. Furthermore we plan to lift the head to remove the pressure, and record the time needed for the measurements to return to baseline.

Detailed Description

When placed in the prone position an external pressure is applied to the NIRS sensor. This pressure changes the amount of blood in the underlying tissue and thereby has an influence on the regional cerebral oxygen saturation measured. We wish to investigate to which extend this value is affected by the external pressure. Furthermore by lifting the head we want to investigate how long takes for the measurements to return to baseline (no pressure in the supine position).

Patients will receive written and oral information about the study, when seen by an anaesthesiologist prior to surgery. Before the anaesthesia one NIRS sensors is placed on the right side of the forehead, avoiding til frontal sinus, and one NIRA sensor is placed on the left musculus deltoideus. The patient is placed in the prone position with the head in af prone-view face mask. Measurements will start after 30 minutes with no change in infusion rate of anaesthetic and no inotropics administered. Registration of NIRS measurements will be done every 15 seconds, first five minutes without intervention, then five minutes with headlift, and last five minutes without interventions. Blood pressure, pulse, saturation, end-tidal carbon dioxide and temperature, will be recorded. Registration wil be om case report forms.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lumbar spine surgical patients		Patients undergoing lumbar spine surgery in the prone position

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the regional cerebral oxygen saturation	Measured by Near Infrared Spectroscopy	15 seconds

Secondary Outcomes

Measure	Description	Time Frame
The duration before the steady state in the regional cerebral oxygen saturation is obtained after changing the head position.		15 seconds

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Surgery in the lumbar spine, in the prone position, with the head in a proneview facemask
Free and painless movement of the neck

Exclusion Criteria:

Known cervical spine pathology.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing lumbar spine surgury, and are placed in the prone position

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johnny DH Andersen, M.D.	University of Copenhagen, Glostrup Hospital, Denmark	Principal Investigator
Hanna Siegel, M.D.	University of Copenhagen, Glostrup Hospital, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Copenhagen, Glostrup Hospital		Copenhagen	Glostrup	2600	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26086290	Derived	Siegel H, Andersen JD, Nielsen RV, Lorentzen K, Olsen KS. Measuring regional cerebral oxygen saturation during surgery in the prone position. Eur J Anaesthesiol. 2016 Feb;33(2):154-5. doi: 10.1097/EJA.0000000000000289. No abstract available.