NCT01971996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 2, 2014

Status Verified

July 1, 2014

Enrollment Period

6 months

First QC Date

October 24, 2013

Last Update Submit

July 1, 2014

Conditions

Anaesthesia

Keywords

Near infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Change in the regional cerebral oxygen saturation

    Measured by Near Infrared Spectroscopy

    15 seconds

Secondary Outcomes (1)

  • The duration before the steady state in the regional cerebral oxygen saturation is obtained after changing the head position.

    15 seconds

Study Arms (1)

Lumbar spine surgical patients

Patients undergoing lumbar spine surgery in the prone position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Known cervical spine pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen, Glostrup Hospital

Copenhagen, Glostrup, 2600, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 26086290DERIVED

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 24, 2013

First Posted

October 30, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 2, 2014

Record last verified: 2014-07

Locations

DK(1)