- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01781091
S4 :Trial Of Fully Closed-Loop Ventilation In ICU. (S4)
May 11, 2017 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
S4 :RANDOMIZED CONTROLLED TRIAL OF FULLY CLOSED-LOOP VENTILATION IN ICU.
Preliminary study to compare IntelliVent-ASV to conventional modes used from intubation to extubation or death in ICU patients requiring mechanical ventilation measuring duration of mechanical ventilation in order to design a multicenter large trial.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Unselected ICU patients invasively ventilated for less than 24 hours, with an expected duration of MV longer than 48 hours.
Exclusion criteria:
- broncho-pleural fistula
- dyshemoglobulinémia
- moribund patient
- do-not-resuscitate order
- chronic respiratory failure requiring long term ventilation,
- patient ventilated more than 24 hours before admission,
- pregnancy,
- age below 18 years,
- protected patients,
- patient already participating in the study,
- Cheynes-Stockes breathing.
- Included patients with a treatment withdrawal decision within 24 hours after inclusion will be excluded,
- patients transferred to another ICU,
- patients needing ECMO, patients randomized to IntelliVent having less than 20% of time in IntelliVent-ASV.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FULLY CLOSED-LOOP VENTILATION
IntelliVent-ASV automatic mode
|
|
Active Comparator: Conventional modes ventilation
Conventional modes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numbers of manual adjustments
Time Frame: participants are followed until they no longer need ventilation, up to 10 days
|
Numbers of manual adjustments of the FULLY CLOSED-LOOP VENTILATION device ( INTELLIVENT ASV)
|
participants are followed until they no longer need ventilation, up to 10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
sedation duration,
Time Frame: participants are followed until they no longer need ventilation, up to 10 days
|
participants are followed until they no longer need ventilation, up to 10 days
|
ventilation parameters
Time Frame: participants are followed until they no longer need ventilation, up to 10 days
|
participants are followed until they no longer need ventilation, up to 10 days
|
Sedation doses
Time Frame: participants are followed until they no longer need ventilation, up to 10 days
|
participants are followed until they no longer need ventilation, up to 10 days
|
Duration of invasive ventilation
Time Frame: participants are followed until they no longer need ventilation, up to 10 days
|
participants are followed until they no longer need ventilation, up to 10 days
|
ICU Mortality
Time Frame: participants are followed until they no longer need ventilation, up to 10 days
|
participants are followed until they no longer need ventilation, up to 10 days
|
28 days mortality
Time Frame: participants are followed until they no longer need ventilation, up to 10 days
|
participants are followed until they no longer need ventilation, up to 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
January 30, 2015
Study Registration Dates
First Submitted
January 24, 2013
First Submitted That Met QC Criteria
January 29, 2013
First Posted (Estimate)
January 31, 2013
Study Record Updates
Last Update Posted (Actual)
May 12, 2017
Last Update Submitted That Met QC Criteria
May 11, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- CH-2012-02
- 2012-A1069-34 (Other Identifier: ANSM( France))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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