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

NCT01875055 | Completed

• 1 other identifier: B2012:118
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cerebral; desaturation

Outcome Measures

Primary Outcomes (1)

• The incidence in the two groups of postoperative cerebral desaturation

  Following the end of the 24 hour time period, the NIRS data will be downloaded and analyzed to determine the incidence in the two groups of postoperative cerebral desaturation, primarily defined by a relative reduction in the rSO2 more than 25% from the baseline pre-anesthesia induction. Furthermore, to determine the overall severity of desaturation, the area under the curve (AUC) for a desaturation less than the previously defined 75% of the baseline will be determined. In addition to assessments of endothelial function and delirium, additional patient data on any adverse events will be collected by reviewing the patient charts as well as by phone interview on post-operation day 30.

  24 hours or unit discharge, which ever occurs first.

Study Arms (2)

NIRS derived cerebral oximetry

EXPERIMENTAL

NIRS derived cerebral oximetry device used but data not visable to ICU caregivers

Device: NIRS derived cerebral oximetry

NIRS and Algorithm

ACTIVE COMPARATOR

NIRS derived cerebral oximetry device used and the caregiver in the ICU will see the data in order to guide the use of the interventional algorithm to treat the cerebral desaturation

Device: NIRS and Algorithm; Device: NIRS derived cerebral oximetry

Interventions

NIRS and Algorithm DEVICE

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

Also known as: EQUANOX NIRS derived cerebral oximetry

NIRS and Algorithm

NIRS derived cerebral oximetry DEVICE

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

Also known as: EQUANOX NIRS derived cerebral oximetry

NIRS and Algorithm; NIRS derived cerebral oximetry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing cardiac surgery employing CPB

You may not qualify if:

• patients having surgeries involving the aorta, or employing deep hypothermic circulatory arrest (DHCA)

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

MeSH Terms

Conditions

Brain Ischemia

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Hillary P Grocott, MD

  Professor Department of Anesthesia and Surgery University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: June 11, 2013
• Study Start: May 1, 2013
• Primary Completion: June 30, 2014
• Study Completion: June 30, 2014
• Last Updated: April 10, 2019

Record last verified: 2013-02

Locations

CA (1)