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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 20, 2014