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

NCT ID: NCT01971996

Last Updated: 2014-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-05-31

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.

Conditions

Anaesthesia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Lumbar spine surgical patients

Patients undergoing lumbar spine surgery in the prone position

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Johnny Andersen

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johnny DH Andersen, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen, Glostrup Hospital, Denmark

Hanna Siegel, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen, Glostrup Hospital, Denmark

Locations

University of Copenhagen, Glostrup Hospital

Copenhagen, Glostrup, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 26086290 (View on PubMed)

Other Identifiers

H-4-2013-FSP

Identifier Type: -

Identifier Source: org_study_id