InvosNCT02079454
Post-operative Cardiac Outcome of Non-cardiac Surgery Predicted by INVOS
An observational study of Invos and Peri-operative, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Research aimed to find a correlation with an invos drop and cardiac events in the peri-operative period of non cardiac surgery. The investigators postulate that a drop in the Invos numbers (with or without significant drop in BP) is associated with a variable degree of cardiac suffering. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invos, Peri-operative, Cardiac Outcome
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2011to Dec 2013
- 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: patient with high cardiac comorbidities undergoing a general anesthesia for a surgery of over two hours with bleding potential.
Who may be able to join
- Male and female
- Age minimum 18 years old
Who cannot join
- Chronic renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Valeur Predictive de l'INVOS Sur l'Outcome Cardiaque en Post-opératoire. (French Title)
Research aimed to find a correlation with an invos drop and cardiac events in the peri-operative period of non cardiac surgery.
The investigators postulate that a drop in the Invos numbers (with or without significant drop in BP) is associated with a variable degree of cardiac suffering.
The idea is to prevent per and foremostpost-operative myocardial necrosis complications by acting as soon as we have an INVOS drop during anesthesia.
The "cardiac events" will be monitored and defined according to the EHA (european heart association) guidelines.
(Changes of the EKG and/or troponin I values above the threshold). Patient will be monitored per and post operatively.
- Conditions
- Invos, Peri-operative, Cardiac Outcome
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite measurement of major vascular events in the post-operative period
Myocardial infarction (measured by positivation of troponin I assay above the defined threshold) associated with clinical data (pain, dyspnea,...) or ST modification on the EKG or apparition of a new LBBB, or new wall abnormalities on the TTE.
Or new TIAs or CVAs
Measured: 96 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startMar 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InvosStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079454
- Sponsor's protocol ID
- invos0001
- Status last verified
- Mar 2014
- First submitted
- 20 Jul 2011
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valeur Predictive de l'INVOS Sur l'Outcome Cardiaque en Post-opératoire. (French Title)
- ClinicalTrials.gov ID
- NCT02079454
- Acronym / sponsor ID
- invos0001
- Conditions
- Invos, Peri-operative, Cardiac Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Mar 2014 (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.
Research aimed to find a correlation with an invos drop and cardiac events in the peri-operative period of non cardiac surgery.
The investigators postulate that a drop in the Invos numbers (with or without significant drop in BP) is associated with a variable degree of cardiac suffering.
The idea is to prevent per and foremostpost-operative myocardial necrosis complications by acting as soon as we have an INVOS drop during anesthesia.
The "cardiac events" will be monitored and defined according to the EHA (european heart association) guidelines.
(Changes of the EKG and/or troponin I values above the threshold). Patient will be monitored per and post operatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with high cardiac comorbidities undergoing a general anesthesia for a surgery of over two hours with bleding potential.
Key inclusion criteria (2 listed)
- Male and female
- Age minimum 18 years old
Key exclusion criteria (1 listed)
- Chronic renal failure
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
A composite measurement of major vascular events in the post-operative period
Time frame: 96 hours post-operative
Myocardial infarction (measured by positivation of troponin I assay above the defined threshold) associated with clinical data (pain, dyspnea,...) or ST modification on the EKG or apparition of a new LBBB, or new wall abnormalities on the TTE. Or new TIAs or CVAs
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 5 Mar 2014.
Related trials for Invos
Not yet recruitingObservational study
Flap Assessment With Regional Oximetry for Early Detection of Compromise in Free Flap Reconstructive Surgery - FLARE Study
Reconstructive Surgery, Flap Monitoring
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Invos and Peri-operative, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 2 inclusion and 1 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 5 Mar 2014. 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 Belgium. 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?
A composite measurement of major vascular events in the post-operative period (time frame: 96 hours post-operative). 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 5 Mar 2014.