Intensive Care Patients Invasively VentilatedPhase 3S4NCT01781091
S4 :Trial Of Fully Closed-Loop Ventilation In ICU.
A Phase 3 study testing INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION and Conventionals Modes in people with Intensive Care Patients Invasively Ventilated, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Patients Invasively Ventilated
- What is being tested?
- INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION and Conventionals Modes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2012to 30 Jan 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unselected ICU patients invasively ventilated for less than 24 hours, with an expected duration of MV longer than 48 hours.
Who cannot join
- 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,
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
France1 site
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Toulon, Paca, 83056
Italy1 site
Anestesia e Rianimazione 2, Fondazione IRCCS Policlinico S. Matteo
Pavia, Lombardy, 27100
About this study
Official title: S4 :RANDOMIZED CONTROLLED 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.
- Being tested
- INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION, Conventionals Modes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATIONDevice
Conventionals ModesDevice
| Study group | Role | What they receive |
|---|---|---|
| FULLY CLOSED-LOOP VENTILATION | Experimental | IntelliVent-ASV automatic mode Receives: Device: INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION |
| Conventional modes ventilation | Active comparator | Conventional modes Receives: Device: Conventionals Modes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of manual adjustments
Numbers of manual adjustments of the FULLY CLOSED-LOOP VENTILATION device ( INTELLIVENT ASV)
Measured: participants are followed until they no longer need ventilation, up to 10 days
Secondary outcomes (6)
sedation duration,
Measured: participants are followed until they no longer need ventilation, up to 10 days
ventilation parameters
Measured: participants are followed until they no longer need ventilation, up to 10 days
Sedation doses
Measured: participants are followed until they no longer need ventilation, up to 10 days
Duration of invasive ventilation
Measured: participants are followed until they no longer need ventilation, up to 10 days
ICU Mortality
Measured: participants are followed until they no longer need ventilation, up to 10 days
28 days mortality
Measured: participants are followed until they no longer need ventilation, up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completion30 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Patients Invasively VentilatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781091
- Sponsor's protocol ID
- CH-2012-02
- Other IDs
- 2012-A1069-34
- Acronym
- S4
- Status last verified
- May 2017
- First submitted
- 24 Jan 2013
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S4 :RANDOMIZED CONTROLLED TRIAL OF FULLY CLOSED-LOOP VENTILATION IN ICU.
- ClinicalTrials.gov ID
- NCT01781091
- Acronym / sponsor ID
- S4 / CH-2012-02
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- 30 Jan 2015 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FULLY CLOSED-LOOP VENTILATION | Experimental | Device: INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATIONIntelliVent-ASV automatic mode |
| Conventional modes ventilation | Active comparator | Device: Conventionals ModesConventional modes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unselected ICU patients invasively ventilated for less than 24 hours, with an expected duration of MV longer than 48 hours.
Key exclusion criteria (14 listed)
- broncho-pleural fistula
- dyshemoglobulinémia
- moribund patient
- do-not-resuscitate order
- chronic respiratory failure requiring long term ventilation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION | Device | FULLY CLOSED-LOOP VENTILATION |
| Conventionals Modes | Device | Conventional modes ventilation |
Primary outcome
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)
6 secondary outcomes
sedation duration,
Time frame: participants are followed until they no longer need ventilation, up to 10 days
ventilation parameters
Time frame: participants are followed until they no longer need ventilation, up to 10 days
Sedation doses
Time frame: participants are followed until they no longer need ventilation, up to 10 days
Duration of invasive ventilation
Time frame: participants are followed until they no longer need ventilation, up to 10 days
ICU Mortality
Time frame: participants are followed until they no longer need ventilation, up to 10 days
28 days mortality
Time frame: participants are followed until they no longer need ventilation, up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION and Conventionals Modes in people with Intensive Care Patients Invasively Ventilated, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of manual adjustments (time frame: participants are followed until they no longer need ventilation, up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.