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

Completed

• Conditions: Conventional Cardiac Surgery With Bypass

• Registration Number: NCT02847273
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-07
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-27
• Last Update Submitted: 2016-07-27
• Study First Posted: 2016-07-28
• Last Update Posted: 2016-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peripheral absolute rSO2 values	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.

Secondary Outcome Measures

Name	Time	Method
heart rate	at conventional cardiac surgery (Day 1)	General monitoring
Arterial pressure	at conventional cardiac surgery (Day 1)	General monitoring
pulse oxygen saturation	at conventional cardiac surgery (Day 1)	General monitoring
Inotrope drugs doses	at conventional cardiac surgery (Day 1)
bispectral index	at conventional cardiac surgery (Day 1)	General monitoring

Trial Locations

Locations (1)

Hôpital Cardiovasculaire et Pneumologique Louis Pradel, Hospices Civils de Lyon; 🇫🇷 Bron, France