NCT02361021

Brief Summary

Evaluation of lung aeration during weaning from mechanical ventilation determined by electrical impedance tomography and lung ultrasound

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

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

February 2, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

1 month

First QC Date

February 2, 2015

Last Update Submit

July 23, 2015

Conditions

Critical CareWeaning From Mechanical VentilationElectrical Impedance TomographyEnd Expiratory Lung VolumeLung Ultrasound Score

Keywords

Critical CareNon invasive ventilationElectrical impedance tomographyEnd expiratory lung volumeLung ultrasound score

Outcome Measures

Primary Outcomes (2)

  • End-expiratory lung volume (EELV)

    End-expiratory lung volume (EELV) determined by electrical impedance tomography at baseline (start of the weaning test)

    at baseline

  • End-expiratory lung volume (EELV)

    \- End-expiratory lung volume (EELV) determined by electrical impedance tomography at Hour 1 (end of the weaning test).

    at hour 1

Secondary Outcomes (4)

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

    at baseline (start of the weaning test)

  • Lung ultrasound score

    at baseline (start of the weaning test)

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

    at Hour 1 (end of the weaning test)..

  • Lung ultrasound score

    at Hour 1 (end of the weaning test)..

Interventions

- Weaning from mechanical ventilationOTHER

Eligibility Criteria

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

Adult ICU patients

You may qualify if:

  • Adult ICU patients during weaning test from mechanical 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

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

February 2, 2015

First Posted

February 11, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

July 24, 2015

Record last verified: 2015-07

Locations

FR(1)