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Reversing Cerebral Oxygen Desaturations Greater That 10% of Baseline Values Using NIRS in the ICU

NCT01875055 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2019-04-10

No results posted yet for this study

Summary

Study objectives: The main objective of this study is to determine the feasibility of implementing measures in the intensive care unit (ICU), based on a physiological algorithm, to reverse decreases in cerebral oxygen saturation using, near-infrared spectroscopy (NIRS).

Methods: Randomization of 50 patients is balanced by experimental group; control and intervention, with an allocation sequence based on a block size of ten, generated with a computer random number generator. In the intervention group ICU Staff will use NIRS to follow a physiologically guided strategy to maintain regional oxygen saturation (rSO2) within 90% of baseline values. In the control group ICU Staff will provide standard of care without the use of NIRS.

Conditions

  • Cerebral Ischemia

Interventions

DEVICE

NIRS and Algorithm

NIRS cerebral oximetry will be used to guide the use of an algorithm based on the modification of previously defined important physiologic variables will be initiated to reverse the desaturation (beginning when the saturation drops at least 10% from the baseline) that occur in the ICU

DEVICE

NIRS derived cerebral oximetry

NIRS sensors will be placed the forehead of the patient but NIRS derived data will be blinded to the ICU caregivers

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Hillary P Grocott, MD · Professor Department of Anesthesia and Surgery University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01875055 on ClinicalTrials.gov