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

Conditions

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.

Study Locations

  • France
    • Paca
      • Toulon, Paca, France, 83056
        • Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
  • Italy
    • Lombardia
      • Pavia, Lombardia, Italy, 27100
        • Anestesia e Rianimazione 2, Fondazione IRCCS Policlinico S. Matteo

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
Device: INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION
Active Comparator: Conventional modes ventilation
Conventional modes
Device: Conventionals 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.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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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