Conventional Cardiac Surgery With BypassNIRS-8NCT02847273
Peripheral Four-wavelength Near-infrared Spectroscopy Measurement: a Comparison Between EQUANOX and O3 in Cardiac Surgery
An observational study of Conventional Cardiac Surgery With Bypass, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conventional Cardiac Surgery With Bypass
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Were included 20 caucasian adult patients scheduled for conventional elective cardiac surgery with cardiopulmonary bypass.
Who may be able to join
- Age >18 years
- Scheduled for conventional elective cardiac surgery with cardiopulmonary bypass
- Hospitalized in the Teaching University Hospital Louis Pradel (Lyon, France)
- Patient agreement
Who cannot join
- Age<18 years
- Black skin
- Emergencies
- Patient refusal
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Cardiovasculaire et Pneumologique Louis Pradel, Hospices Civils de Lyon
Bron, 69500
About this study
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.
- Conditions
- Conventional Cardiac Surgery With Bypass
- Keywords
- NIRS, Regional oxygen saturation, cardiac surgery with bypass
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral absolute rSO2 values
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.
Measured: at conventional cardiac surgery (Day 1)
Secondary outcomes (5)
Arterial pressure
General monitoring
Measured: at conventional cardiac surgery (Day 1)
heart rate
General monitoring
Measured: at conventional cardiac surgery (Day 1)
pulse oxygen saturation
General monitoring
Measured: at conventional cardiac surgery (Day 1)
bispectral index
General monitoring
Measured: at conventional cardiac surgery (Day 1)
Inotrope drugs doses
Measured: at conventional cardiac surgery (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conventional Cardiac Surgery With BypassStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Fellahi, Pr, MD PhD, Principal investigator, Hôpital Cardiovasculaire et Pneumologique Louis Pradel, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847273
- Sponsor's protocol ID
- 69HCL16_0502
- Acronym
- NIRS-8
- Status last verified
- Jul 2016
- First submitted
- 25 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Four-wavelength Near-infrared Spectroscopy Measurement: a Comparison Between EQUANOX and O3 in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02847273
- Acronym / sponsor ID
- NIRS-8 / 69HCL16_0502
- Conditions
- Conventional Cardiac Surgery With Bypass
- Keywords
- NIRS, Regional oxygen saturation, cardiac surgery with bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Were included 20 caucasian adult patients scheduled for conventional elective cardiac surgery with cardiopulmonary bypass.
Key inclusion criteria (4 listed)
- Age >18 years
- Scheduled for conventional elective cardiac surgery with cardiopulmonary bypass
- Hospitalized in the Teaching University Hospital Louis Pradel (Lyon, France)
- Patient agreement
Key exclusion criteria (4 listed)
- Age<18 years
- Black skin
- Emergencies
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Arterial pressure
Time frame: at conventional cardiac surgery (Day 1)
heart rate
Time frame: at conventional cardiac surgery (Day 1)
pulse oxygen saturation
Time frame: at conventional cardiac surgery (Day 1)
bispectral index
Time frame: at conventional cardiac surgery (Day 1)
Inotrope drugs doses
Time frame: at conventional cardiac surgery (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Luc Fellahi, Pr, MD PhD principal investigator
Hôpital Cardiovasculaire et Pneumologique Louis Pradel, Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conventional Cardiac Surgery With Bypass, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral absolute rSO2 values (time frame: at conventional cardiac surgery (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.