Respiratory FailurePhase 3IntelliventNCT01577667
Intellivent Versus Conventional Ventilation
A Phase 3 study testing Intellivent; automatic mode implemented on a S1 ventilator in people with Respiratory Failure and Self Efficacy, run by Hamilton Medical AG at 1 site in Belgium.
Trial summary
Partial automation of mechanical ventilation in resuscitation has been available for several years. New modalities are being developed to completely automate ventilation and oxygenation parameters (IntelliVent®. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Respiratory Failure, Self Efficacy
- What is being tested?
- Intellivent; automatic mode implemented on a S1 ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2011to Jun 2012
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Patient under invasive ventilation for more than 6 hours and for a planned duration of at least 48 hours
- Body Mass Index (current weight (kg)/height (m)²) < 40
- Signature of an informed consent by the family
Who cannot join
- Need for ventricular assistance with intra-aortic balloon counterpulsation.
- Presence of a bronchopleural fistula
- Pregnant women: A pregnancy blood test will be performed in women of reproductive age. The results will be communicated to the patient by a physician of her choice.
- Adults under guardianship
- People deprived of freedom
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Monocenter RCT Comparing Safety and Efficacy of an Automated Closed-loop Oxygenation and Ventilation(IntelliVent® System - HAMILTON MEDICAL AG) With Non-automated Conventional Ventilation and Oxygenation
Partial automation of mechanical ventilation in resuscitation has been available for several years. New modalities are being developed to completely automate ventilation and oxygenation parameters (IntelliVent®.
This pilot study compares over a 48h period the safety and efficacy of IntelliVent®, versus a conventional ventilation modality.
Read the detailed description
Rational: Partial automation of mechanical ventilation in resuscitation has been available for several years. It can deliver a continuous ventilation adapted in real time to the patient's clinical condition,and decrease care workload and ventilation weaning duration. New modalities are being developed to completely automate ventilation and oxygenation parameters (IntelliVent®) and preliminary studies show that over short periods (2 to 4 h) such a system can ventilate patients more optimally and more safely, with a better ventilation efficiency (comparable effect on gas exchanges for a less "aggressive" ventilation). This pilot study compares over a longer period (48 hours), the safety and efficacy of IntelliVent®, versus a usual ventilation modality.
Type of study: Monocenter, comparative, prospective, randomized, parallel study.
Objective: To assess IntelliVent® safety, efficacy, and care workload.
Assessment criteria:
- Safety is assessed by measuring the number of times it is necessary to manually intervene on the ventilator settings because for one the following parameters: A range SpO2, EtCO2, plateau pressure (Pplat), tidal volume (VT), respiratory rate (RR),values considered as non-optimal, as defined a priori and consensually by a panel of experts.
- Efficacy, in terms of ventilation, is assessed by the time spent within a range EtCO2 and Pplat and VT and RR values considered as optimal, as defined a priori and consensually by a panel of experts.
Efficacy, in terms of oxygenation, is assessed by the time spent within a range SpO2 values considered as optimal, as defined a priori and consensually by a panel of experts.
- Care workload is assessed by the number of ventilator setting adjustments by nursing staff in each group.
Number of subjects: 80 patients receiving invasive mechanical ventilation for acute respiratory failure.
Methods: The selected patients presenting with inclusion criteria are ventilated either with IntelliVent® or with the unit's usual ventilation following a random selection.
- Conditions
- Respiratory Failure, Self Efficacy
- Being tested
- Intellivent; automatic mode implemented on a S1 ventilator
- Keywords
- automation, closed loop, oxygenation, ventilation
- Medical subject headings
- Respiratory Insufficiency, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intellivent; automatic mode implemented on a S1 ventilatorDevice
Also called Closed-loop ventilation
Intellivent allows an automatic adjustment of the following parameters: FiO2, PEEP and %VM according to adjusted parameters: Size, SpO2 and EtCO2
| Study group | Role | What they receive |
|---|---|---|
| Conventional ventilation | No intervention | Usual ventilation is administered according to the protocols implemented in the unit |
| Intellivent | Experimental | Intellivent is a ventilatory mode included in ventilator S1, Hamilton Medical. Intervention: the patient is ventilated with the same ventilator than in the conventionnal group; but the "ASV-Intellivent" ventilation has to be activated via a dedicated key on the ventilator screen.
IntelliVent® activation requires selecting the kind of patient: ARDS, COPD and whether hemodynamic instability exists.
The initial settings are IntelliVent® by default settings (% MV: 110%, PEEP: 5 cm H2O, FiO2: 60% - 100% in case of ARDS).
Therefore modification of these various parameters is automatic. FiO2 and PEP are modified according to SpO2; %MV according to EtCO2. Receives: Device: Intellivent; automatic mode implemented on a S1 ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety is assessed by measuring the number of times it is necessary to manually intervene on the ventilator settings because for one the following parameters: A range SpO2, EtCO2, plateau pressure (Pplat), tidal volume (VT), respiratory rate (RR) values considered as non-optimal, as defined a priori and consensually by a panel of experts.
Measured: 48 Hours
Secondary outcomes (2)
Efficacy
Efficacy, in terms of ventilation, is assessed by the time spent within a range EtCO2 and Pplat-proxi and VT and RR values considered as optimal, as defined a priori and consensually by a panel of experts.
Efficacy, in terms of oxygenation, is assessed by the time spent within a range SpO2 values considered as optimal, as defined a priori and consensually by a panel of experts.
Measured: 48 Hours
Care workload
Care workload is assessed by the number of ventilator setting adjustments by nursing staff in each group.
Measured: 48H
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startFeb 2011
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Medical AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre-François Laterre, Pr, Principal investigator, Reanimation, Cliniques Universitaires Saint Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577667
- Sponsor's protocol ID
- Intellivent RCT1
- Acronym
- Intellivent
- Status last verified
- Dec 2012
- First submitted
- 11 Apr 2012
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Monocenter RCT Comparing Safety and Efficacy of an Automated Closed-loop Oxygenation and Ventilation(IntelliVent® System - HAMILTON MEDICAL AG) With Non-automated Conventional Ventilation and Oxygenation
- ClinicalTrials.gov ID
- NCT01577667
- Acronym / sponsor ID
- Intellivent / Intellivent RCT1
- Conditions
- Respiratory Failure, Self Efficacy
- Keywords
- automation, closed loop, oxygenation, ventilation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hamilton Medical AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Apr 2012 (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.
Partial automation of mechanical ventilation in resuscitation has been available for several years. New modalities are being developed to completely automate ventilation and oxygenation parameters (IntelliVent®.
This pilot study compares over a 48h period the safety and efficacy of IntelliVent®, versus a conventional ventilation modality.
Detailed description
Rational: Partial automation of mechanical ventilation in resuscitation has been available for several years. It can deliver a continuous ventilation adapted in real time to the patient's clinical condition,and decrease care workload and ventilation weaning duration. New modalities are being developed to completely automate ventilation and oxygenation parameters (IntelliVent®) and preliminary studies show that over short periods (2 to 4 h) such a system can ventilate patients more optimally and more safely, with a better ventilation efficiency (comparable effect on gas exchanges for a less "aggressive" ventilation). This pilot study compares over a longer period (48 hours), the safety and efficacy of IntelliVent®, versus a usual ventilation modality.
Type of study: Monocenter, comparative, prospective, randomized, parallel study.
Objective: To assess IntelliVent® safety, efficacy, and care workload.
Assessment criteria:
- Safety is assessed by measuring the number of times it is necessary to manually intervene on the ventilator settings because for one the following parameters: A range SpO2, EtCO2, plateau pressure (Pplat), tidal volume (VT), respiratory rate (RR),values considered as non-optimal, as defined a priori and consensually by a panel of experts.
- Efficacy, in terms of ventilation, is assessed by the time spent within a range EtCO2 and Pplat and VT and RR values considered as optimal, as defined a priori and consensually by a panel of experts.
Efficacy, in terms of oxygenation, is assessed by the time spent within a range SpO2 values considered as optimal, as defined a priori and consensually by a panel of experts.
- Care workload is assessed by the number of ventilator setting adjustments by nursing staff in each group.
Number of subjects: 80 patients receiving invasive mechanical ventilation for acute respiratory failure.
Methods: The selected patients presenting with inclusion criteria are ventilated either with IntelliVent® or with the unit's usual ventilation following a random selection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ventilation | No intervention | –Usual ventilation is administered according to the protocols implemented in the unit |
| Intellivent | Experimental | Device: Intellivent; automatic mode implemented on a S1 ventilatorIntellivent is a ventilatory mode included in ventilator S1, Hamilton Medical. Intervention: the patient is ventilated with the same ventilator than in the conventionnal group; but the "ASV-Intellivent" ventilation has to be activated via a dedicated key on the ventilator screen. IntelliVent® activation requires selecting the kind of patient: ARDS, COPD and whether hemodynamic instability exists. The initial settings are IntelliVent® by default settings (% MV: 110%, PEEP: 5 cm H2O, FiO2: 60% - 100% in case of ARDS). Therefore modification of these various parameters is automatic. FiO2 and PEP are modified according to SpO2; %MV according to EtCO2. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Patient under invasive ventilation for more than 6 hours and for a planned duration of at least 48 hours
- Body Mass Index (current weight (kg)/height (m)²) < 40
- Signature of an informed consent by the family
Key exclusion criteria (5 listed)
- Need for ventricular assistance with intra-aortic balloon counterpulsation.
- Presence of a bronchopleural fistula
- Pregnant women: A pregnancy blood test will be performed in women of reproductive age. The results will be communicated to the patient by a physician of her choice.
- Adults under guardianship
- People deprived of freedom
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; automatic mode implemented on a S1 ventilatorAlso: Closed-loop ventilationIntellivent allows an automatic adjustment of the following parameters: FiO2, PEEP and %VM according to adjusted parameters: Size, SpO2 and EtCO2 | Device | Intellivent |
Primary outcome
Safety
Time frame: 48 Hours
Safety is assessed by measuring the number of times it is necessary to manually intervene on the ventilator settings because for one the following parameters: A range SpO2, EtCO2, plateau pressure (Pplat), tidal volume (VT), respiratory rate (RR) values considered as non-optimal, as defined a priori and consensually by a panel of experts.
2 secondary outcomes
Efficacy
Time frame: 48 Hours
Care workload
Time frame: 48H
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 6 Dec 2012.
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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.
Pierre-François Laterre, Pr principal investigator
Reanimation, Cliniques Universitaires Saint Luc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intellivent; automatic mode implemented on a S1 ventilator in people with Respiratory Failure and Self Efficacy, run by Hamilton Medical AG at 1 site in Belgium.
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 4 inclusion and 5 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 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Safety (time frame: 48 Hours). 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 6 Dec 2012.