NCT02150018

Brief Summary

Effect of Non Invasive Ventilation on end-expiratory lung volumes determined by electrical impedance tomography

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

May 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1.5 years

First QC Date

May 26, 2014

Last Update Submit

July 30, 2015

Conditions

- Critical CareNon Invasive VentilationElectrical Impedance TomographyEnd Expiratory Lung VolumeEnd Expiratory Lung Impedance

Keywords

- Critical CareNon invasive ventilationElectrical impedance tomographyEnd expiratory lung volumeEnd expiratory lung impedance

Outcome Measures

Primary Outcomes (1)

  • - End-expiratory lung volume (EELV) determined by electrical impedance tomography before, during and after NIV

    at day 1

Secondary Outcomes (2)

  • Anterior, medio-anterior, medio-posterior and posterior EELV

    at day 1

  • Ventilatory frequency

    at day 1

Study Arms (1)

non invasive ventilation (NIV)

Other: non invasive ventilation

Interventions

non invasive ventilationOTHER
non invasive ventilation (NIV)

Eligibility Criteria

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

patients requiring non invasive ventilation

You may qualify if:

  • Adult ICU patients requiring non invasive ventilation
  • Consent of patients or family
  • Arterial line

You may not qualify if:

  • Tracheotomized patients
  • Dressings in the thoracic area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Sebastien PERBET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2014

First Posted

May 29, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

FR(1)