Hemodynamic and Biological Evaluations During Reventilation Collapse in ICU (REVECOL)

February 5, 2013 updated by: University Hospital, Clermont-Ferrand
Prospective, observational clinical multicentric study in ICU; during the period surrounding the orotracheal intubation.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Defined population

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
reventilation collapse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reventilation collapse
Time Frame: at day 1 (at least thirty minutes despite 500 or 1000ml of fluid resuscitation)
at day 1 (at least thirty minutes despite 500 or 1000ml of fluid resuscitation)

Secondary Outcome Measures

Outcome Measure
Time Frame
reventilation collapse
Time Frame: in the last 72 hours
in the last 72 hours
Duration of mechanical ventilation
Time Frame: at day 1
at day 1
mortality
Time Frame: at day 28
at day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

November 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

February 1, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

February 7, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0142
  • DC-2012-1501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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