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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02847273

Acronym

NIRS-8

Enrollment

Registered

2016-07-28

Start date

2015-09-30

Completion date

2015-12-31

Last updated

2016-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conventional Cardiac Surgery With Bypass

Keywords

NIRS, Regional oxygen saturation, cardiac surgery with bypass

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results