Hemodynamic and Biological Evaluations During Reventilation Collapse in ICU (REVECOL)
Primary Purpose
Arterial Line, Consent of Patients, Adult Patients
Status
Unknown status
Phase
Locations
France
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Arterial Line focused on measuring Reventilation collapse, Rate of reventilation collapse, Risk factor of reventilation collapse, Hemodynamic profile of reventilation collapse, Biologic approach of reventilation collapse
Eligibility Criteria
Inclusion Criteria:
- Arterial line
- Consent of patients
- Adult patients
- Tracheal intubation in ICU
Exclusion Criteria:
- tracheal intubation for cardiac arrest
- pregnant woman
- major protected
Sites / Locations
- CHU Clermont-Ferrand
Arms of the Study
Arm 1
Arm Type
Arm Label
reventilation collapse
Arm Description
Outcomes
Primary Outcome Measures
Reventilation collapse
Secondary Outcome Measures
reventilation collapse
Duration of mechanical ventilation
mortality
Full Information
NCT ID
NCT01785654
First Posted
February 1, 2013
Last Updated
February 5, 2013
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT01785654
Brief Title
Hemodynamic and Biological Evaluations During Reventilation Collapse in ICU
Acronym
REVECOL
Official Title
Hemodynamic and Biological Evaluations During Reventilation Collapse in ICU
Study Type
Observational
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Line, Consent of Patients, Adult Patients, Tracheal Intubation in ICU
Keywords
Reventilation collapse, Rate of reventilation collapse, Risk factor of reventilation collapse, Hemodynamic profile of reventilation collapse, Biologic approach of reventilation collapse
7. Study Design
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
reventilation collapse
Primary Outcome Measure Information:
Title
Reventilation collapse
Time Frame
at day 1 (at least thirty minutes despite 500 or 1000ml of fluid resuscitation)
Secondary Outcome Measure Information:
Title
reventilation collapse
Time Frame
in the last 72 hours
Title
Duration of mechanical ventilation
Time Frame
at day 1
Title
mortality
Time Frame
at day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Arterial line
Consent of patients
Adult patients
Tracheal intubation in ICU
Exclusion Criteria:
tracheal intubation for cardiac arrest
pregnant woman
major protected
Study Population Description
Defined population
Sampling Method
Non-Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastien PERBET
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
12. IPD Sharing Statement
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Hemodynamic and Biological Evaluations During Reventilation Collapse in ICU
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