Cardiac SurgeryCLOSER1NCT01090258
Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller
A study testing Hamilton ventilator (G5 modify to S1) Automated settings and Hamilton ventilator (G5) protocolized settings in people with Cardiac Surgery and Mechanically Ventilated Patients, run by Laval University.
Trial summary
The study compares automated settings (Intellivent) with protocolized settings of the ventilator after cardiac surgery. The settings concern the respiratory rate, the inspiratory and expiratory pressure and FiO2. The aim of the study is to demonstrate that automated settings are feasible and safe. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Surgery, Mechanically Ventilated Patients
- What is being tested?
- Hamilton ventilator (G5 modify to S1) Automated settings and Hamilton ventilator (G5) protocolized settings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Dec 2009
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Unexpected surgical procedure
- Major complication during surgery
- Early extubation expected (< 1 hour)
- Broncho-pleural fistula
- Study ventilator not available
About this study
The study compares automated settings (Intellivent) with protocolized settings of the ventilator after cardiac surgery. The settings concern the respiratory rate, the inspiratory and expiratory pressure and FiO2. The aim of the study is to demonstrate that automated settings are feasible and safe.
The study design is a randomized controled study. 30 patients will be ventilated with automated mode and 30 patients with protocolized settings after cardiac surgery.
The hypothesis is that the automated mode allows a safer ventilation with better maintain of the patient in predefined optimal zone of ventilation.
Read the detailed description
Aim: feasibility and safety study = evaluation of the possibility for a fully automated ventilator to safely manage the ventilation and oxygenation after cardiac surgery
Hypothesis:
Intellivent will maintain the patient with " optimal ventilation " better than during usual management with a minimal number of interventions
Monocentric: IUCPQ, Hôpital Laval, Québec Randomized controlled safety study, unblinded Patients after elective cardiac surgery Two arms Intellivent (fully automatic ventilation) Protocolized ventilation 4 hours study 60 patients planned to be included Primary outcome: number of episodes in the " not acceptable " zone of ventilation and duration
Secondary outcome:
Number of episodes in the " acceptable " zone of ventilation and duration Number of manual settings and duration of interventions Comparison of arterial blood gases Time to wean the FiO2 the PEEP Time to begin the assisted ventilation Duration of mechanical ventilation
- Conditions
- Cardiac Surgery, Mechanically Ventilated Patients
- Being tested
- Hamilton ventilator (G5 modify to S1) Automated settings, Hamilton ventilator (G5) protocolized settings
- Keywords
- cardiac surgery, mechanical ventilation, automation, weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hamilton ventilator (G5 modify to S1) Automated settingsDevice
Also called Intellivent
Automated settings (respiratory rate [RR], FiO2, Insp and exp pressures) Ventilator settings automatically adjusted by the evaluated system, concerning the FiO2, the respiratory rate, the inspiratory and expiratory pressures and related settings (triggers, pressurization ramp, inspiratory/expiratory time...)
Hamilton ventilator (G5) protocolized settingsOther
Mechanical ventilation settings performed by the respiratory therapists according to the local protocols
| Study group | Role | What they receive |
|---|---|---|
| Automated settings | Experimental | Ventilator settings automatically adjusted by the evaluated system, concerning the FiO2, the respiratory rate, the inspiratory and expiratory pressures and related settings (triggers, pressurization ramp, inspiratory/expiratory time...) Receives: Device: Hamilton ventilator (G5 modify to S1) Automated settings |
| protocolized settings | Active comparator | Ventilator settings performed by the local respiratory therapists according to the local protocols Receives: Other: Hamilton ventilator (G5) protocolized settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
" not acceptable " zone of ventilation
Number of episodes, duration and percentage of time in the " not acceptable " zone of ventilation as pre-defined
Measured: During the four hours of the study protocol
" not acceptable " zone of ventilation
Number of episodes, duration and percentage of time in the " not acceptable " zone of ventilation as pre-defined
Measured: During the 4 hours of the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François Lellouche, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090258
- Sponsor's protocol ID
- CS-2009
- Acronym
- CLOSER1
- Status last verified
- Feb 2014
- First submitted
- 18 Mar 2010
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lellouche F, Bouchard PA, Simard S, L'Her E, Wysocki M. Evaluation of fully automated ventilation: a randomized controlled study in post-cardiac surgery patients. Intensive Care Med. 2013 Mar;39(3):463-71. doi: 10.1007/s00134-012-2799-2. Epub 2013 Jan 22.
PubMed 23338569
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller
- ClinicalTrials.gov ID
- NCT01090258
- Acronym / sponsor ID
- CLOSER1 / CS-2009
- Conditions
- Cardiac Surgery, Mechanically Ventilated Patients
- Keywords
- cardiac surgery, mechanical ventilation, automation, weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Mar 2010 (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.
The study compares automated settings (Intellivent) with protocolized settings of the ventilator after cardiac surgery. The settings concern the respiratory rate, the inspiratory and expiratory pressure and FiO2. The aim of the study is to demonstrate that automated settings are feasible and safe.
The study design is a randomized controled study. 30 patients will be ventilated with automated mode and 30 patients with protocolized settings after cardiac surgery.
The hypothesis is that the automated mode allows a safer ventilation with better maintain of the patient in predefined optimal zone of ventilation.
Detailed description
Aim: feasibility and safety study = evaluation of the possibility for a fully automated ventilator to safely manage the ventilation and oxygenation after cardiac surgery
Hypothesis:
Intellivent will maintain the patient with " optimal ventilation " better than during usual management with a minimal number of interventions
Monocentric: IUCPQ, Hôpital Laval, Québec Randomized controlled safety study, unblinded Patients after elective cardiac surgery Two arms Intellivent (fully automatic ventilation) Protocolized ventilation 4 hours study 60 patients planned to be included Primary outcome: number of episodes in the " not acceptable " zone of ventilation and duration
Secondary outcome:
Number of episodes in the " acceptable " zone of ventilation and duration Number of manual settings and duration of interventions Comparison of arterial blood gases Time to wean the FiO2 the PEEP Time to begin the assisted ventilation Duration of mechanical ventilation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated settings | Experimental | Device: Hamilton ventilator (G5 modify to S1) Automated settingsVentilator settings automatically adjusted by the evaluated system, concerning the FiO2, the respiratory rate, the inspiratory and expiratory pressures and related settings (triggers, pressurization ramp, inspiratory/expiratory time...) |
| protocolized settings | Active comparator | Other: Hamilton ventilator (G5) protocolized settingsVentilator settings performed by the local respiratory therapists according to the local protocols |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Unexpected surgical procedure
- Major complication during surgery
- Early extubation expected (< 1 hour)
- Broncho-pleural fistula
- Study ventilator not available
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 |
|---|---|---|
| Hamilton ventilator (G5 modify to S1) Automated settingsAlso: IntelliventAutomated settings (respiratory rate [RR], FiO2, Insp and exp pressures) Ventilator settings automatically adjusted by the evaluated system, concerning the FiO2, the respiratory rate, the inspiratory and expiratory pressures and related settings (triggers, pressurization ramp, inspiratory/expiratory time...) | Device | Automated settings |
| Hamilton ventilator (G5) protocolized settingsMechanical ventilation settings performed by the respiratory therapists according to the local protocols | Other | protocolized settings |
Primary outcome
" not acceptable " zone of ventilation
Time frame: During the four hours of the study protocol
Number of episodes, duration and percentage of time in the " not acceptable " zone of ventilation as pre-defined
" not acceptable " zone of ventilation
Time frame: During the 4 hours of the protocol
Number of episodes, duration and percentage of time in the " not acceptable " zone of ventilation as pre-defined
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 25 Feb 2014.
- Derived from this study: PubMed 23338569Lellouche F, Bouchard PA, Simard S, L'Her E, Wysocki M. Evaluation of fully automated ventilation: a randomized controlled study in post-cardiac surgery patients. Intensive Care Med. 2013 Mar;39(3):463-71. doi: 10.1007/s00134-012-2799-2. Epub 2013 Jan 22.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Hamilton ventilator (G5 modify to S1) Automated settings and Hamilton ventilator (G5) protocolized settings in people with Cardiac Surgery and Mechanically Ventilated Patients, run by Laval University.
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 0 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 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
" not acceptable " zone of ventilation (time frame: During the four hours of the study protocol). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01090258, which also lists 1 linked publication.
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 25 Feb 2014.