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

Intensive Care Patients Invasively Ventilated Clinical Trial

— S4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781091
• Other study ID #: CH-2012-02
• Secondary ID: 2012-A1069-34
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2013
• Last updated: May 11, 2017
• Start date: December 2012
• Est. completion date: January 30, 2015

Study information

• Verified date: May 2017
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 30, 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intensive Care Patients Invasively Ventilated

Intervention

Device:
• INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION

• Conventionals Modes

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer	Toulon	Paca
Italy	Anestesia e Rianimazione 2, Fondazione IRCCS Policlinico S. Matteo	Pavia	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of manual adjustments	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	sedation duration,		participants are followed until they no longer need ventilation, up to 10 days
Secondary	ventilation parameters		participants are followed until they no longer need ventilation, up to 10 days
Secondary	Sedation doses		participants are followed until they no longer need ventilation, up to 10 days
Secondary	Duration of invasive ventilation		participants are followed until they no longer need ventilation, up to 10 days
Secondary	ICU Mortality		participants are followed until they no longer need ventilation, up to 10 days
Secondary	28 days mortality		participants are followed until they no longer need ventilation, up to 10 days