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Completed

NCT Number: NCT01781091

S4 :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.

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Key information

Conditions

Intensive Care Patients Invasively Ventilated

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Toulon, Paca, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION

Device

Conventionals Modes

Device

Primary outcomes

  1. 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)

Secondary outcomes

  1. sedation duration,

    Time frame: participants are followed until they no longer need ventilation, up to 10 days

  2. ventilation parameters

    Time frame: participants are followed until they no longer need ventilation, up to 10 days

  3. Sedation doses

    Time frame: participants are followed until they no longer need ventilation, up to 10 days

  4. Duration of invasive ventilation

    Time frame: participants are followed until they no longer need ventilation, up to 10 days

  5. ICU Mortality

    Time frame: participants are followed until they no longer need ventilation, up to 10 days

  6. 28 days mortality

    Time frame: participants are followed until they no longer need ventilation, up to 10 days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Official study title

S4 :RANDOMIZED CONTROLLED TRIAL OF FULLY CLOSED-LOOP VENTILATION IN ICU.

Acronym: S4

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Jan 31, 2013
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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