Tracheostomy and Weaning From Mechanical Ventilation : Ev... | NCT01793363

Studies
Tracheostomy and Weaning From Mechanical Ventilation : Evaluation of the Lung Ultrasound Score

NCT01793363

Sponsor

University Hospital, Clermont-Ferrand

Status

Completed

Last Update Posted

Jul 24, 2015Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Tracheotomy

Interventions

Tracheotomy

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
2012-A00366-37

Status Module

Record Verification Date

Jul 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

Aug 2012

Primary Completion Date

Jun 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Feb 7, 2013

First Submission Date that Met QC Criteria

Feb 14, 2013

First Posted Date

Feb 15, 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

Jul 23, 2015

Last Update Posted Date

Jul 24, 2015Estimated

Name	Class
Groupe Hospitalier Pitie-Salpetriere	OTHER

Description Module

Brief Summary

Prospective, interventional multicentric study in ICU during weaning from mechanical ventilation in tracheotomized patients

Detailed Description

Prospective multicentric study on ICU evaluating Lung Ultrasound Score in tracheotomized patients during weaning from mechanical ventilation

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Label	Type	Description	Intervention Names
tracheotomized patients	Experimental		Procedure: Tracheotomy

Name	Type	Description	Arm Group Labels	Other Names
Tracheotomy	Procedure		tracheotomized patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Variation of lung ultrasound score		at day 1

Secondary Outcomes

Measure	Description	Time Frame
Time to weaning from mechanical ventilation		at day 1
Length of hospital stay		Day 1 + 90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients tracheotomised during ICU stay
Consent of patients

Exclusion Criteria:

Tracheotomy before ICU
No echogenicity

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

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

Intervention Browse Module

MeSH Terms

ID	Term
D014140	Tracheotomy

Ancestor Terms

ID	Term
D013517	Otorhinolaryngologic Surgical Procedures
D013514	Surgical Procedures, Operative
D019616	Thoracic Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided