NCT02380547

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

June 19, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2016

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

February 23, 2015

Last Update Submit

March 21, 2018

Conditions

Critical CareInvasive Mechanical Ventilation

Keywords

SonographyDiaphragmatic functionNon invasive ventilationCritical care patientsExtubation after 24 hours of invasive ventilation

Outcome Measures

Primary Outcomes (6)

  • 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

Interventions

Sonographic diaphragmatic measurementsOTHER
Also known as: Diaphragmatic excursion, Diaphragmatic thickening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critical care patients (surgical or medical)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'anesthésie- réanimation chirurgicale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Study Officials

  • Gharib AJOB, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2015

First Posted

March 5, 2015

Study Start

June 19, 2015

Primary Completion

July 15, 2016

Study Completion

July 15, 2016

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

FR(1)