NCT01483495

Brief Summary

The brain is such a metabolically active organ that it consumes about 20% of oxygen burned every minute by an average adult even though it only contributes about 2% of the body weight. As a result, the brain produces a disproportionately high amount of CO2 every minute in comparison with the rest of the body.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

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

August 2, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

Same day

First QC Date

August 2, 2011

Last Update Submit

October 28, 2022

Conditions

Hypoxia-Ischemia, BrainSigns and Symptoms

Outcome Measures

Primary Outcomes (1)

  • Brain blood flow

    Optical Imaging assess of Brain blood flow during surgical procedure

    6 hours

Study Arms (1)

Diagnostic tool

Diffuse Optical Spectroscopy Imaging Cerebrovascular Reactivity

Device: Diffuse optical spectroscopy

Interventions

Diffuse optical spectroscopyDEVICE

Diffuse Optical Spectroscopy Imaging Cerebrovascular Reactivity

Also known as: Diffuse Optical Spectroscopy Imaging
Diagnostic tool

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elective surgery

You may qualify if:

  • Male or Female 20 years of age and older
  • Female non-pregnant
  • Subject scheduled for elective surgery under general anesthesia with intubation.
  • Subject who is able to give informed consent.

You may not qualify if:

  • Less than 20 years old of age
  • Pregnant woman
  • Subjects currently diagnosed with severe hypertension, myocardial ischemic disease, symptomatic valvular disease(s), symptomatic arrhythmia, uncompensated congestive heart failure, intracranial aneurysm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCI Beckman Laser Institute

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, BrainSigns and Symptoms

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratoryPathological Conditions, Signs and Symptoms

Study Officials

  • Bruce Tromberg, PhD

    Beckman Laser Institute

    STUDY DIRECTOR

  • Lingzhong Meng, M.D

    Anesthesiology Perioperative Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lingzhong Meng, M.D.,Assistant Clinical Professor and Director of Neuroanesthesia

Study Record Dates

First Submitted

August 2, 2011

First Posted

December 1, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)