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OpenTrials
Completed

NCT Number: NCT02847273

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

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.

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Key information

Conditions

Conventional Cardiac Surgery With Bypass

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Cardiovasculaire et Pneumologique Louis Pradel, Hospices Civils de Lyon

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Arterial pressure

    Time frame: at conventional cardiac surgery (Day 1)

    General monitoring

  2. heart rate

    Time frame: at conventional cardiac surgery (Day 1)

    General monitoring

  3. pulse oxygen saturation

    Time frame: at conventional cardiac surgery (Day 1)

    General monitoring

  4. bispectral index

    Time frame: at conventional cardiac surgery (Day 1)

    General monitoring

  5. Inotrope drugs doses

    Time frame: at conventional cardiac surgery (Day 1)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: NIRS-8

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 28, 2016
Registry last updated
Jul 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.