S4 :Trial Of Fully Closed-Loop Ventilation In ICU.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier:
NCT01781091
First received: January 24, 2013
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Intensive Care Patients Invasively Ventilated
Device: INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION
Device: Conventionals Modes
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: S4 :RANDOMIZED CONTROLLED TRIAL OF FULLY CLOSED-LOOP VENTILATION IN ICU.

Further study details as provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer:

Primary Outcome Measures:
  • Numbers of manual adjustments [ Time Frame: participants are followed until they no longer need ventilation, up to 10 days ] [ Designated as safety issue: Yes ]
    Numbers of manual adjustments of the FULLY CLOSED-LOOP VENTILATION device ( INTELLIVENT ASV)


Secondary Outcome Measures:
  • sedation duration, [ Time Frame: participants are followed until they no longer need ventilation, up to 10 days ] [ Designated as safety issue: No ]
  • ventilation parameters [ Time Frame: participants are followed until they no longer need ventilation, up to 10 days ] [ Designated as safety issue: Yes ]
  • Sedation doses [ Time Frame: participants are followed until they no longer need ventilation, up to 10 days ] [ Designated as safety issue: No ]
  • Duration of invasive ventilation [ Time Frame: participants are followed until they no longer need ventilation, up to 10 days ] [ Designated as safety issue: No ]
  • ICU Mortality [ Time Frame: participants are followed until they no longer need ventilation, up to 10 days ] [ Designated as safety issue: Yes ]
  • 28 days mortality [ Time Frame: participants are followed until they no longer need ventilation, up to 10 days ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: December 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781091

Locations
France
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Toulon, Paca, France, 83056
Italy
Anestesia e Rianimazione 2, Fondazione IRCCS Policlinico S. Matteo
Pavia, Lombardia, Italy, 27100
Sponsors and Collaborators
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
  More Information

No publications provided

Responsible Party: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier: NCT01781091     History of Changes
Other Study ID Numbers: CH-2012-02, 2012-A1069-34
Study First Received: January 24, 2013
Last Updated: April 16, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

ClinicalTrials.gov processed this record on April 17, 2014