NCT01702779

Brief Summary

This is a prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

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

August 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 8, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

1.8 years

First QC Date

April 24, 2012

Last Update Submit

November 28, 2014

Conditions

Adult Patients Ventilated More Than 48 hStable Respiratory and Hemodynamic Conditions for SBTConsent of PatientsArterial Line

Keywords

Weaning from mechanical ventilationLung ultrasoundOxygen inhalation therapy

Outcome Measures

Primary Outcomes (1)

  • variations of lung ultrasound score

    24 hours after extubation

Secondary Outcomes (4)

  • Lung ultrasound score

    at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation

  • rates of patients with postextubation distress

    during the 48th post-extubation

  • Electrical Impedance tomography

    at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation

  • Epithelial and endothelial biomarkers

    at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation

Study Arms (2)

optiflow

OTHER
Other: mechanical ventilation

O2

OTHER
Other: mechanical ventilation

Interventions

mechanical ventilationOTHER

Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.

optiflow

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients ventilated more than 48 h
  • Stable respiratory and hemodynamic conditions for SBT
  • Consent of patients
  • Arterial line

You may not qualify if:

  • COBP
  • Laryngeal dyspnea
  • Tracheostomy
  • Arythmya
  • No echogenicity
  • Paraplegia \>T8

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Interventions

Respiration, Artificial

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • Sébastien PERBET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2012

First Posted

October 8, 2012

Study Start

August 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

FR(1)