NCT00448877

Brief Summary

The purpose of this study is to determine whether or not a new brain function monitor can distinguish between anesthetized and awake patients. The device implemented utilizes functional near-infrared (fNIR) technology to detect anesthesia depth as well as reaction to stimuli during surgical procedure. After obtaining consent the device is placed across the forehead of the patient. A baseline signal is obtained prior to induction. The fNIR signal is continuously recorded throughout the procedure. Key events as well as administration of drug are recorded in order to observe changes in the signal trend. Neither the device nor the light emitted is hazardous to the patient - no risks or discomforts are involved.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

April 7, 2009

Status Verified

April 1, 2008

Enrollment Period

7 months

First QC Date

March 15, 2007

Last Update Submit

April 6, 2009

Conditions

Surgical Procedures, Operative

Keywords

No specific disease is being studied, few procedures are excluded.The focus of the study is to rule out the efficacy of the device, so the aim is to include as wide a variety of procedures as possible.

Outcome Measures

Primary Outcomes (1)

  • This is a proof of concept study, primary outcome measure includes observation and calculation of causal relationships of oxygenated and de-oxygenated hemoglobin during administration of anesthetic.

Interventions

fNIR light emitting and sensing deviceDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who will have surgery
  • years old
  • No restrictions on gender, race, or religion

You may not qualify if:

  • Head and face surgery
  • Induced hypotension
  • Profound anemia
  • Scar/tattoo on forehead
  • Prior history of frontal lobe surgery
  • Hemoglobinopathies
  • Patients not undergoing general anesthesia
  • Surgeries in the prone position
  • Allergy to adhesive tape

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

Study Officials

  • Jay Horrow, MD

    Drexel University College of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 15, 2007

First Posted

March 19, 2007

Study Start

December 1, 2006

Primary Completion

July 1, 2007

Last Updated

April 7, 2009

Record last verified: 2008-04

Locations

US(1)