Pilot Study of the Feasibility of Multicenter NIRS Data Collection and Interventions for Desaturation in Cardiac Surgery

August 17, 2017 updated by: Johns Hopkins University

Using the 9 centers (Appendix B) involved with the planned multicenter NIRS comparative effectiveness trial the specific aims of this study are:

  1. To demonstrate the feasibility of collecting rScO2 data from patients undergoing cardiac surgery in a multicenter study design.
  2. To demonstrate the feasibility of using a standard algorithm for treating rScO2 desaturations during cardiac surgery in a multicenter study design.

Study Overview

Status

Completed

Conditions

Detailed Description

Brain injury after cardiac surgery is a chief source of patient mortality and healthcare costs and can significantly impair quality of life. Reducing the burden of this complication has wide public health implications. The broad manifestations of perioperative brain injury include stroke, delirium, and cognitive decline.5 All forms of injury are believed to result primarily from cerebral embolism and/or reduced cerebral blood flow (CBF). The risk for cerebral hypoperfusion is likely the highest during cardiopulmonary bypass (CPB), when mean arterial pressure (MAP) is kept low (~60 mmHg), particularly for patients who are aged and who have cerebral vascular disease. Near-infrared spectroscopy (NIRS) is used increasingly to monitor regional cerebral oxygen saturation (rScO2) in patients undergoing cardiac surgery, although limited data show that it improves patient outcomes. Regardless, clinical evidence supporting the efficacy of NIRS-based monitoring is needed urgently because the cost of NIRS sensors (~$220/patient) could add $132 million annually to hospital costs for cardiac surgery. We must address this issue quickly because the rising prevalence of NIRS use and advocacy by experts and industry will likely soon result in NIRS becoming a standard of care. We are in the process of submitting a multicenter, prospectively randomized comparative effectiveness trial to assess the efficacy of NIRS monitoring in patients who are undergoing coronary artery bypass graft (CABG) surgery with CPB, and/or valve surgery, and who are at risk for brain injury. The goal of the planned proposal is to determine whether interventions to correct rScO2 desaturations (value <50% or 20% reduction from room air baseline) reduce the frequency of neurologic and other complications compared with standard care (no clinical monitoring). In order to demonstrate feasibility of our proposal we need to demonstrate the ability of the team to collect rScO2 data from multiple centers and to show the ability of the team to properly follow an algorithm for treating rScO2 desaturations that occur during surgery. Thus, the aim of the current study is to collect preliminary data to support our larger comparative effectiveness trial.

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient inclusion criteria will be male or female patients >50 years of age undergoing primary or re-operative CABG and/or cardiac valve surgery that requires CPB who will have NIRS monitoring for clinical indications.

Description

Inclusion Criteria: Patient inclusion criteria will be male or female patients >50 years of age undergoing primary or re-operative CABG and/or cardiac valve surgery that requires CPB who will have NIRS monitoring for clinical indications.

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Exclusion Criteria: Emergency surgery

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rScO2 desaturation data collection
Time Frame: During Surgery
During Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Charles W Hogue, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

January 3, 2013

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimate)

January 10, 2013

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Multicenter NIRS Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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