Criteria of Extubation Failure of Brain Injured Patients.... | NCT02235376

Studies
Criteria of Extubation Failure of Brain Injured Patients. Elaboration of a Prognostic Score.

NCT02235376

Sponsor

University Hospital, Clermont-Ferrand

Status

Completed

Last Update Posted

Oct 15, 2015Estimated

Enrollment

140Actual

Phase

Not provided

Conditions

Brain Injury

Interventions

weaning trial of mechanical ventilation

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

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Jul 28, 2014

First Submission Date that Met QC Criteria

Sep 9, 2014

First Posted Date

Sep 10, 2014Estimated

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

Oct 13, 2015

Last Update Posted Date

Oct 15, 2015Estimated

Description Module

Brief Summary

Identification of criteria associated with extubation failure of brain injured patients. Elaboration of a prognostic score of extubation failure of brain injured patients.

Detailed Description

Prospective clinical study in ICU with brain injured ventilated patients eligible to extubation.

Identification of clinical and biological criteria associated with failure of extubation.

Elaboration of a prognostic score of extubation failure of brain injured patients, based on criteria previously identified with multivariate analysis.

Failure of extubation is defined by the need of re-intubation or the need for non-invasive ventilation within 48 hours or more after extubation.

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

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Label	Type	Description	Intervention Names
critical care			Other: weaning trial of mechanical ventilation

Name	Type	Description	Arm Group Labels	Other Names
weaning trial of mechanical ventilation	Other		critical care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation	- Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation within 48 hours or during ICU stay	at day 2

Secondary Outcomes

Measure	Description	Time Frame
Severity scores (SAPS II, SOFA, GCS…) ) at patient admission in ICU		at ady 1
Cause of brain injury (traumatic, ischemic, hemorrhagic or post-operative) at patient admission in ICU		at day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult brain injured patients ventilated eligible to discontinuation of mechanical ventilation
Stable respiratory and hemodynamic conditions
Ventilated patients for more than 48 hours
Adequate gaseous exchange (SpO2 ≥ 92% and respiratory rate ≤ 35/min, FiO2 ≤ 40%, positive end-expiratory pressure ≤ 5 cmH2O, pressure support ≤ 8 cmH2O, tidal volume ≥ 7mL/kg
Therapeutic extubation

Exclusion Criteria:

• Status epilepticus
- Cerebrospinal infection
- Patients under 15 years old
- Mechanical ventilation of < 48 h
- Spinal cord injury
- Withdrawal of life support

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

brain injured patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Russell CHABANNE	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D001930	Brain Injuries

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma

Browse Leaves

Not provided

Browse Branches

Not provided