Cough Peak Flow for Extubation Prediction | NCT02847221

Studies
Cough Peak Flow for Extubation Prediction

NCT02847221

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Jul 28, 2016Estimated

Enrollment

92Actual

Phase

Not provided

Conditions

Extubation in ICU Patients

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

Status Module

Record Verification Date

Jul 2016

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

Nov 2014

Primary Completion Date

Oct 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Jul 25, 2016

First Submission Date that Met QC Criteria

Jul 25, 2016

First Posted Date

Jul 28, 2016Estimated

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 25, 2016

Last Update Posted Date

Jul 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Successful weaning from mechanical ventilation in ICU patients depends on patient ability to breathe spontaneously and on cough efficiency. Previous studies found that cough peak flow (CPF) at 60 L/min threshold predicted extubation failure. These studies measured CPF using a dedicated flow-meter that required patient disconnection from the ventilator, limiting the generalizability of this procedure. This study aimed to predict extubation outcome in a consecutive series of patients by measuring CPF from the ventilator flow-meter. CPF measurements were done by freezing ventilator screen and scrolling the cursor to the maximal value of CPF during expiration and Tidal Volume (TV) in preceding inspiration.

The objective was to assess the performance of CPF to predict early extubation outcome.

Detailed Description

Not provided

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

92Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Early extubation success rate (EES rate)	Defining a relation between the CPF/TV ratio before extubation and early extubation success rate	48 hours

Secondary Outcomes

Measure	Description	Time Frame
Scheduled weaning trial success rate	Defining a relation between the CPF/TV ratio before weaning trial and scheduled weaning trial success rate	48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
Intubation > 24h
Eligible for scheduled weaning trial and then scheduled extubation
Mechanical ventilation from Evita XL ventilator (Dräger, Germany)
Patient's agreement to participate

Exclusion Criteria:

- Withdrawal decision of life supporting care

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

Patients admitted to a 15-bed medical ICU from November 1st 2014 to October 31st 2015

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Florent GOBERT, MD	Hospices Civils de Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Intensive care unit, Croix-Rousse Hospital. 103 Grande Rue de la Croix-Rousse		Lyon		69004	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28900041	Derived	Gobert F, Yonis H, Tapponnier R, Fernandez R, Labaune MA, Burle JF, Barbier J, Vincent B, Cleyet M, Richard JC, Guerin C. Predicting Extubation Outcome by Cough Peak Flow Measured Using a Built-in Ventilator Flow Meter. Respir Care. 2017 Dec;62(12):1505-1519. doi: 10.4187/respcare.05460. Epub 2017 Sep 12.