Brain Injured PatientsNCT01695603
Comparison of a New Automated Ventilatory Mode Named Intellivent to Standard Controlled Ventilation in Brain Injured Patients
A study testing Intellivent in people with Brain Injured Patients, run by Prof. Philippe Jolliet at 1 site in Switzerland.
Trial summary
Comparison of the ability of a new automated ventilatory mode named Intellibrain to maintain capnia and oxgen partial pressure within predefined ranges in comparison to the control of capnia and oxgen partial pressure obtained by using standard controlled ventilation modes in brain injured patients. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Brain Injured Patients
- What is being tested?
- Intellivent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2012to Mar 2017
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Brain injury ( traumatic brain injury, subarachnoi8dal haemorrhage, intracerebral hemorrhage, ischemic stroke)
- Glasgow coma scale of 9 or less
- Controlled mechanical ventilation required
- Intracranial pressure monitoring required for clinical reasons
Who cannot join
- age under 16 years old
- clinical signs of brainstem lesions
- patients with withdrawal order or for whom organ donation is under discussion
- major haemodynamic instability
- High carbon dioxide alveoloarterial gradient (>10 mmHg) and/or suffering of severe hypoxemia (PaO2/FIO2 < 150 mmHg)
- Patients included in another interventional clinical study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Adult Intensive Care and Burn Unit, University hospital of Lausanne
Lausanne, 1012
About this study
Comparison of the ability of a new automated ventilatory mode named Intellibrain to maintain capnia and oxgen partial pressure within predefined ranges in comparison to the control of capnia and oxgen partial pressure obtained by using standard controlled ventilation modes in brain injured patients. Comparison of the numbers of alarms and required settings modifications observed with each ventilatory mode.
- Conditions
- Brain Injured Patients
- Being tested
- Intellivent
- Keywords
- Brain injury, Controlled ventilation, Intellivent, Capnia control
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntelliventDevice
| Study group | Role | What they receive |
|---|---|---|
| Standard mode of controlled ventilation | No intervention | Each brain injured patient will be ventilated during two hours with a standard mode of controlled ventilation. |
| Intellivent arm | Experimental | Each brain injured patient will be ventilated during two hours with an automated mode of ventilation, the Intellivent mode. Receives: Device: Intellivent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial pressure of carbon dioxide
The partial pressure of carbon dioxide (PaCO2) will be recorded every thirty minutes during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
Secondary outcomes (9)
Partial pressure of oxygen
The partial pressure of oxygen (PaCO2) will be recorded every thirty minutes during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
Number of alarms generated by the ventilator
The number of alarms generated by the ventilator will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
Number of settings modifications
The number of ventilator settings modifications required will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
Intracranial pressure
Intracranial pressure will be recorded continuously during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
Respiratory parameters
Various respiratory parameters tidal volume, respiratory rate, minute ventilation, airway pressure) will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
Cerebral vasoreactivity
Cerebral vasoreactivity will be studied from the intracranial pressure and invasive arterial pressure curves recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
Partial pressure of oxygen in the brain tissue if available
Partial pressure of oxygen in the brain tissue, if available for clinical reasons, will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
Number of therapeutic actions needed to reduce intracranial pressure
The number of therapeutic actions needed to reduce intracranial pressure will be recorded during two hours under standard controlled ventilation and during two hours under Intellivent ventilation.
Cerebral perfusion pressure
Cerebral perfusion pressure will be recorded continuously during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injured PatientsStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Philippe Jolliet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Sponsor-investigator, Prof. Philippe Jolliet, University of Lausanne Hospitals
- Investigators
- Philippe Jolliet, Prof, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695603
- Sponsor's protocol ID
- Intellibrain
- Status last verified
- May 2017
- First submitted
- 20 Sep 2012
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a New Automated Ventilatory Mode Named Intellivent to Standard Controlled Ventilation in Brain Injured Patients
- ClinicalTrials.gov ID
- NCT01695603
- Acronym / sponsor ID
- Intellibrain
- Conditions
- Brain Injured Patients
- Keywords
- Brain injury, Controlled ventilation, Intellivent, Capnia control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Prof. Philippe JollietUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- Mar 2012
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 28 Sep 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.
Comparison of the ability of a new automated ventilatory mode named Intellibrain to maintain capnia and oxgen partial pressure within predefined ranges in comparison to the control of capnia and oxgen partial pressure obtained by using standard controlled ventilation modes in brain injured patients. Comparison of the numbers of alarms and required settings modifications observed with each ventilatory mode.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard mode of controlled ventilation | No intervention | –Each brain injured patient will be ventilated during two hours with a standard mode of controlled ventilation. |
| Intellivent arm | Experimental | Device: IntelliventEach brain injured patient will be ventilated during two hours with an automated mode of ventilation, the Intellivent mode. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Brain injury ( traumatic brain injury, subarachnoi8dal haemorrhage, intracerebral hemorrhage, ischemic stroke)
- Glasgow coma scale of 9 or less
- Controlled mechanical ventilation required
- Intracranial pressure monitoring required for clinical reasons
Key exclusion criteria (6 listed)
- age under 16 years old
- clinical signs of brainstem lesions
- patients with withdrawal order or for whom organ donation is under discussion
- major haemodynamic instability
- High carbon dioxide alveoloarterial gradient (>10 mmHg) and/or suffering of severe hypoxemia (PaO2/FIO2 < 150 mmHg)
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 | Device | Intellivent arm |
Primary outcome
Partial pressure of carbon dioxide
The partial pressure of carbon dioxide (PaCO2) will be recorded every thirty minutes during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
9 secondary outcomes
Partial pressure of oxygen
Number of alarms generated by the ventilator
Number of settings modifications
Intracranial pressure
Respiratory parameters
Cerebral vasoreactivity
Partial pressure of oxygen in the brain tissue if available
Number of therapeutic actions needed to reduce intracranial pressure
Cerebral perfusion pressure
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 8 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.
Philippe Jolliet, Prof principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intellivent in people with Brain Injured Patients, run by Prof. Philippe Jolliet at 1 site in Switzerland.
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 6 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 8 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 1 site in Switzerland. 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.
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?
Partial pressure of carbon dioxide. 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 8 May 2017.