NCT01785654

Brief Summary

Prospective, observational clinical multicentric study in ICU; during the period surrounding the orotracheal intubation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

1.7 years

First QC Date

February 1, 2013

Last Update Submit

February 5, 2013

Conditions

Arterial LineConsent of PatientsAdult PatientsTracheal Intubation in ICU

Keywords

Reventilation collapseRate of reventilation collapseRisk factor of reventilation collapseHemodynamic profile of reventilation collapseBiologic approach of reventilation collapse

Outcome Measures

Primary Outcomes (1)

  • Reventilation collapse

    at day 1 (at least thirty minutes despite 500 or 1000ml of fluid resuscitation)

Secondary Outcomes (3)

  • reventilation collapse

    in the last 72 hours

  • Duration of mechanical ventilation

    at day 1

  • mortality

    at day 28

Study Arms (1)

reventilation collapse

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Defined population

You may qualify if:

  • Arterial line
  • Consent of patients
  • Adult patients
  • Tracheal intubation in ICU

You may not qualify if:

  • tracheal intubation for cardiac arrest
  • pregnant woman
  • major protected

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Study Officials

  • Sebastien PERBET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2013

First Posted

February 7, 2013

Study Start

March 1, 2013

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

FR(1)