Arterial LineREVECOLNCT01785654
Hemodynamic and Biological Evaluations During Reventilation Collapse in ICU
An observational study of Arterial Line and Consent of Patients, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Prospective, observational clinical multicentric study in ICU; during the period surrounding the orotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Line, Consent of Patients, Adult Patients
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Dec 2014
- 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: Defined population
Who may be able to join
- Arterial line
- Consent of patients
- Adult patients
- Tracheal intubation in ICU
Who cannot join
- tracheal intubation for cardiac arrest
- pregnant woman
- major protected
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
Prospective, observational clinical multicentric study in ICU; during the period surrounding the orotracheal intubation.
Read the detailed description
Main objective: to describe the characteristics of reventilation collapse: collapse rate, duration and treatment implemented
Secondary objectives:
- identify risk factors of reventilation collapse
- compare mortality, hemodynamic, respiratory, infectious and biological data between collapse group and no reventilation collapse group.
- Keywords
- Reventilation collapse, Rate of reventilation collapse, Risk factor of reventilation collapse, Hemodynamic profile of reventilation collapse, Biologic approach of reventilation collapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| reventilation collapse | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reventilation collapse
Measured: at day 1 (at least thirty minutes despite 500 or 1000ml of fluid resuscitation)
Secondary outcomes (3)
reventilation collapse
Measured: in the last 72 hours
Duration of mechanical ventilation
Measured: at day 1
mortality
Measured: at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial LineStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien PERBET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785654
- Sponsor's protocol ID
- CHU-0142
- Other IDs
- DC-2012-1501
- Acronym
- REVECOL
- Status last verified
- Feb 2013
- First submitted
- 1 Feb 2013
- Last updated
- 7 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic and Biological Evaluations During Reventilation Collapse in ICU
- ClinicalTrials.gov ID
- NCT01785654
- Acronym / sponsor ID
- REVECOL / CHU-0142
- Keywords
- Reventilation collapse, Rate of reventilation collapse, Risk factor of reventilation collapse, Hemodynamic profile of reventilation collapse, Biologic approach of reventilation collapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 7 Feb 2013 (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.
Prospective, observational clinical multicentric study in ICU; during the period surrounding the orotracheal intubation.
Detailed description
Main objective: to describe the characteristics of reventilation collapse: collapse rate, duration and treatment implemented
Secondary objectives:
- identify risk factors of reventilation collapse
- compare mortality, hemodynamic, respiratory, infectious and biological data between collapse group and no reventilation collapse group.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| reventilation collapse | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Defined population
Key inclusion criteria (4 listed)
- Arterial line
- Consent of patients
- Adult patients
- Tracheal intubation in ICU
Key exclusion criteria (3 listed)
- tracheal intubation for cardiac arrest
- pregnant woman
- major protected
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
Reventilation collapse
Time frame: at day 1 (at least thirty minutes despite 500 or 1000ml of fluid resuscitation)
3 secondary outcomes
reventilation collapse
Time frame: in the last 72 hours
Duration of mechanical ventilation
Time frame: at day 1
mortality
Time frame: at day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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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.
Sebastien PERBET principal investigator
University Hospital, Clermont-Ferrand
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 Arterial Line and Consent of Patients, run by University Hospital, Clermont-Ferrand 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 3 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: status not confirmed, as of the sponsor's last update on 7 Feb 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reventilation collapse (time frame: at day 1 (at least thirty minutes despite 500 or 1000ml of fluid resuscitation)). 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 7 Feb 2013.