NCT02138903

Brief Summary

Comparing the hemodynamic and cardiac effects of two types of weaning trials of mechanical ventilation in ICU patients of two French ICU.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

10 months

First QC Date

April 11, 2014

Last Update Submit

November 28, 2014

Conditions

Critical CareWeaning of Mechanical VentilationTrans-thoracic EchocardiographyMitral DopplerDiastolic Function

Keywords

weaningCardiacEchocardiographyMechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • left ventricular filling pressure

    Echo-cardiographic evaluation is realized at the end of the weaning trial (1 hour) or less if failed

    after 1 hour

Secondary Outcomes (1)

  • Comparison of other echocardiographic parameters of left ventricular filling pressures

    after 1 hour

Study Arms (2)

ZEEP and tubing-spontaneous ventilation

Prospective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography.

Other: trans thoracic echocardiography

trans-thoracic echocardiography

Prospective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography.

Other: trans thoracic echocardiography

Interventions

trans thoracic echocardiographyOTHER
ZEEP and tubing-spontaneous ventilationtrans-thoracic echocardiography

Eligibility Criteria

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

ICU patients

You may qualify if:

  • Adult patients ventilated requiring first weaning trial of mechanical ventilation
  • Stable respiratory and hemodynamic conditions
  • Consent of patients or family
  • Arterial line
  • Ventilated patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Study Officials

  • Sébastien PERBET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2014

First Posted

May 15, 2014

Study Start

January 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

FR(1)