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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
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 1, 2013
Last Updated
February 5, 2013
Sponsor
University Hospital, Clermont-Ferrand
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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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