Hemodynamic and Biological Evaluations During Reventilation Collapse in ICU

Adult Patients Clinical Trial

— REVECOL  

Official title:

Hemodynamic and Biological Evaluations During Reventilation Collapse in ICU

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01785654
• Other study ID #: CHU-0142
• Secondary ID: DC-2012-1501
• Status: Not yet recruiting
• Phase: N/A
• First received: February 1, 2013
• Last updated: February 5, 2013
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Adult Patients
• Arterial Line
• Consent of Patients
• Tracheal Intubation in ICU

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reventilation collapse		at day 1 (at least thirty minutes despite 500 or 1000ml of fluid resuscitation)	No
Secondary	reventilation collapse		in the last 72 hours	No
Secondary	Duration of mechanical ventilation		at day 1	No
Secondary	mortality		at day 28	No