Peripheral Four-wavelength Near-infrared Spectroscopy Measurement: a Comparison Between EQUANOX and O3 in Cardiac Surgery (NIRS-8)

July 27, 2016 updated by: Hospices Civils de Lyon
Near-infrared spectroscopy (NIRS) is a continuous and non-invasive technology that measures regional tissue oxygen saturation (rSO2). Whatever the anatomical site of measurement, a normal value of rSO2 would suggest a good adequacy between oxygen supply and consumption at the regional level. Beside the trend ability of previous 2 or 3-wavelength devices, a new 4-wavelength generation of NIRS monitors which could reliably assess real-time absolute values of rSO2 is now available. The investigators aimed to compare peripheral absolute rSO2 values given by the 4-wavelength EQUANOX device 7600 (Nonin Medical, Plymouth, Mn) and the new O3 device (Masimo, Irvine, CA) during conventional cardiac surgery.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

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

  • France
      • Bron, France, 69500
        • Hôpital Cardiovasculaire et Pneumologique Louis Pradel, Hospices Civils de Lyon

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Were included 20 caucasian adult patients scheduled for conventional elective cardiac surgery with cardiopulmonary bypass.

Description

Inclusion Criteria:

  • Age >18 years
  • Scheduled for conventional elective cardiac surgery with cardiopulmonary bypass
  • Hospitalized in the Teaching University Hospital Louis Pradel (Lyon, France)
  • Patient agreement

Exclusion Criteria:

  • Age<18 years
  • Black skin
  • Emergencies
  • Patient refusal

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral absolute rSO2 values
Time Frame: at conventional cardiac surgery (Day 1)
Peripheral absolute rSO2 values given by the 4-wavelength EQUANOX device 7600 (Nonin Medical, Plymouth, Mn) and the new O3 device (Masimo, Irvine, CA) during conventional cardiac surgery.
at conventional cardiac surgery (Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial pressure
Time Frame: at conventional cardiac surgery (Day 1)
General monitoring
at conventional cardiac surgery (Day 1)
heart rate
Time Frame: at conventional cardiac surgery (Day 1)
General monitoring
at conventional cardiac surgery (Day 1)
pulse oxygen saturation
Time Frame: at conventional cardiac surgery (Day 1)
General monitoring
at conventional cardiac surgery (Day 1)
bispectral index
Time Frame: at conventional cardiac surgery (Day 1)
General monitoring
at conventional cardiac surgery (Day 1)
Inotrope drugs doses
Time Frame: at conventional cardiac surgery (Day 1)
at conventional cardiac surgery (Day 1)

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Jean-Luc Fellahi, Pr, MD PhD, Hôpital Cardiovasculaire et Pneumologique Louis Pradel, Hospices Civils de Lyon

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

September 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

July 27, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL16_0502

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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