Cardiac Surgery and Diaphragm Function | NCT02208479

Studies
Cardiac Surgery and Diaphragm Function

NCT02208479

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Sep 23, 2015Estimated

Enrollment

66Actual

Phase

Not provided

Conditions

Cardiac Surgery

Interventions

Non invasive ultrasound measurement of the diaphragm thickness during breathing

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

Sep 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 2014

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Aug 1, 2014

First Submission Date that Met QC Criteria

Aug 4, 2014

First Posted Date

Aug 5, 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

Sep 22, 2015

Last Update Posted Date

Sep 23, 2015Estimated

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

Diaphragm dysfunction is common after cardiac surgery and may delay weaning from mechanical ventilation and cause respiratory distress.

The investigators' main objective is to determine the incidence of diaphragm dysfunction ( using the non-invasive ultrasonic method by calculating the inspiratory diaphragmatic thickening fraction) in a selected population of cardiac surgery patients during weaning from mechanical ventilation.

The second endpoints are to determine the associated risk factors to post-operative diaphragm weakness and the consequence on the patient 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

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cardiac surgery			Other: Non invasive ultrasound measurement of the diaphragm thickness during breathing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non invasive ultrasound measurement of the diaphragm thickness during breathing	Other		cardiac surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diaphragm inspiratory thickening fraction		At the begining of the spontaneous breathing trial (around 4hours after surgery)

Secondary Outcomes

Measure	Description	Time Frame
Diaphragm dysfunction before surgery		the day before surgery
Severity score (Euroscore)		the day before surgery
extracorporeal circulation duration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years old and older
planned surgery
ready for weaning from mechanical ventilation

Exclusion Criteria:

protected patient
patient refusal

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

patient admitted in Intensive Care Unit (ICU) after planned cardiac surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unité de Réanimation Cardio-vasculaire et Thoracique		Grenoble		38043	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24365607	Background	DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.
22397655	Background	McCool FD, Tzelepis GE. Dysfunction of the diaphragm. N Engl J Med. 2012 Mar 8;366(10):932-42. doi: 10.1056/NEJMra1007236. No abstract available.

ID	Term
D012133	Respiratory Paralysis
D018908	Muscle Weakness
D012131	Respiratory Insufficiency

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010243	Paralysis
D009461	Neurologic Manifestations