Hemodynamic and Biological Evaluations During Reventilati... | NCT01785654

Studies
Hemodynamic and Biological Evaluations During Reventilation Collapse in ICU

NCT01785654

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Feb 7, 2013Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Arterial Line
Consent of Patients
Adult Patients
Tracheal Intubation in ICU

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DC-2012-1501

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Nov 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Feb 1, 2013

First Submission Date that Met QC Criteria

Feb 5, 2013

First Posted Date

Feb 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2013

Last Update Posted Date

Feb 7, 2013Estimated

Description Module

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.

Conditions Module

Conditions

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Label	Type	Description	Intervention Names
reventilation collapse

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Defined population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick LACARIN	Contact	04 73 75 11 95		placarin@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Sebastien PERBET	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Clermont-Ferrand		Clermont-Ferrand		63003	France