Sonographic Evaluation of Diaphragmatic Function in Criti... | NCT02380547

Studies
Sonographic Evaluation of Diaphragmatic Function in Critical Care Patients With Use of Non Invasive Ventilation

NCT02380547

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

Mar 22, 2018Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Critical Care
Invasive Mechanical Ventilation

Interventions

Sonographic diaphragmatic measurements

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

Mar 2018

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 19, 2015Actual

Primary Completion Date

Jul 15, 2016Actual

Completion Date

Jul 15, 2016Actual

First Submitted Date

Feb 23, 2015

First Submission Date that Met QC Criteria

Feb 27, 2015

First Posted Date

Mar 5, 2015Estimated

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

Mar 21, 2018

Last Update Posted Date

Mar 22, 2018Actual

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

Usefulness of non invasive ventilation in patients extubated after more than 48 hours of invasive ventilation is still in debate except for specific patients (chronic pulmonary disease and chronic heart failure).

Many experimental and clinical studies have shown that diaphragmatic function is depressed by mechanical ventilation in intubated patients.

The investigators will test the hypothesis that non invasive ventilation after extubation may improve diaphragmatic function

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

15Actual

Name	Type	Description	Arm Group Labels	Other Names
Sonographic diaphragmatic measurements	Other			Diaphragmatic excursion Diaphragmatic thickening

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diaphragmatic excursion		Before the first NIV session
Diaphragmatic thickening		Before the first NIV session
Diaphragmatic excursion		After the first NIV session
Diaphragmatic thickening		After the first NIV session
Diaphragmatic excursion		After 24 h of NIV use
Diaphragmatic thickening		After 24 h of NIV use

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient extubated after at least 48 hours of invasive ventilation
Requiring non invasive ventilation
Consent of patient

Exclusion Criteria:

Diaphragmatic paralysis
Neuromuscular disease
significant pleural effusion
atelectasis requiring bronchoscopy
abdominal hypertension

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

Critical care patients (surgical or medical)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gharib AJOB, MD	Hôpitaux Universitaires de Strasbourg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'anesthésie- réanimation chirurgicale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg		Strasbourg		67091	France