NCT01781091

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2012

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2015

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

January 24, 2013

Last Update Submit

May 11, 2017

Conditions

Intensive Care Patients Invasively Ventilated

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • sedation duration,

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

  • ventilation parameters

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

  • Sedation doses

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

  • Duration of invasive ventilation

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

  • ICU Mortality

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

  • +1 more secondary outcomes

Study Arms (2)

FULLY CLOSED-LOOP VENTILATION

EXPERIMENTAL

IntelliVent-ASV automatic mode

Device: INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION

Conventional modes ventilation

ACTIVE COMPARATOR

Conventional modes

Device: Conventionals Modes

Interventions

INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATIONDEVICE
FULLY CLOSED-LOOP VENTILATION
Conventionals ModesDEVICE
Conventional modes ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Unselected ICU patients invasively ventilated for less than 24 hours, with an expected duration of MV longer than 48 hours.

You may not qualify if:

  • 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.
  • patients transferred to another ICU,
  • patients needing ECMO, patients randomized to IntelliVent having less than 20% of time in IntelliVent-ASV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Toulon, Paca, 83056, France

Location

Anestesia e Rianimazione 2, Fondazione IRCCS Policlinico S. Matteo

Pavia, Lombardy, 27100, Italy

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2013

First Posted

January 31, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

January 30, 2015

Last Updated

May 12, 2017

Record last verified: 2017-05

Locations

FR(1)IT(1)