Ventilation, MechanicalPhase 4AFONNCT00927745
Clinical Evaluation of AutoFlow Mode During Mechanical Ventilation
A Phase 4 study testing AutoFlow mode on Evita 4 Dräger ventilators and Evita 4 Dräger ventilators in people with Ventilation, Mechanical, run by Centre Hospitalier Victor Dupouy at 1 site in France.
Trial summary
The purpose of this study is to evaluate the long term use of AutoFlow mode during mechanical ventilation in ICU patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilation, Mechanical
- What is being tested?
- AutoFlow mode on Evita 4 Dräger ventilators and Evita 4 Dräger ventilators
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2002to Dec 2003
- Phase
- Phase 4
- 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
- adult patients under assist-controlled ventilation with an Evita 4 ventilator (Dräger, France) for an expected duration of more than two days
Who cannot join
- coma
- ventilation longer than 12 hours prior to inclusion
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Clinical Evaluation of AutoFlow Mode During Assist-Controlled Ventilation in ICU Patients
The purpose of this study is to evaluate the long term use of AutoFlow mode during mechanical ventilation in ICU patients
Read the detailed description
Many new mechanical ventilation modes are proposed without clinical evaluation. Among them, "dual-controlled" modes, as AutoFlow, are supposed to improve patient-ventilator interfacing, and could led to lesser alarm. This study is a long term clinical evaluation of AutoFlow during assist-controlled ventilation, focusing on its efficacy (on gas exchange and outcome) and on ventilator alarms.
- Conditions
- Ventilation, Mechanical
- Being tested
- AutoFlow mode on Evita 4 Dräger ventilators, Evita 4 Dräger ventilators
- Keywords
- Respiration Artificial, Positive-Pressure Respiration, Critical Care, Intensive Care Units
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoFlow mode on Evita 4 Dräger ventilatorsDevice
Activation of AutoFlow mode during assist-controlled ventilation
Evita 4 Dräger ventilatorsDevice
Assist-controlled ventilation without activation of AutoFlow mode
| Study group | Role | What they receive |
|---|---|---|
| With AutoFlow | Experimental | Assist-controlled ventilation with activation of AutoFlow mode Receives: Device: AutoFlow mode on Evita 4 Dräger ventilators |
| Without AutoFlow | Active comparator | Assist-controlled ventilation without activation of AutoFlow mode Receives: Device: Evita 4 Dräger ventilators |
What is being measured
The primary outcome is the main question the study is designed to answer.
gas exchange
Measured: daily during mechanical ventilation
sedation length
Measured: ICU discharge
ventilator alarm rates
Measured: daily during mechanical ventilation
Secondary outcomes (5)
length of mechanical ventilation
Measured: ICU discharge
ventilator asssociated pneumonia rate
Measured: ICU discharge
SOFA score
Measured: daily during mechanical ventilation
death rate
Measured: ICU discharge
cumulative sedation drugs dosage
Measured: ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startDec 2002
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation, MechanicalStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Victor Dupouy
- Sponsor type
- University, hospital or other
- Investigators
- Hervé MENTEC, MD, Study director, Centre Hospitalier Victor Dupouy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927745
- Sponsor's protocol ID
- AFON study
- Acronym
- AFON
- Status last verified
- Jun 2009
- First submitted
- 24 Jun 2009
- Last updated
- 25 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Clinical Evaluation of AutoFlow Mode During Assist-Controlled Ventilation in ICU Patients
- ClinicalTrials.gov ID
- NCT00927745
- Acronym / sponsor ID
- AFON / AFON study
- Conditions
- Ventilation, Mechanical
- Keywords
- Respiration Artificial, Positive-Pressure Respiration, Critical Care, Intensive Care Units
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre Hospitalier Victor DupouyUniversity, hospital or other
- Study start
- Dec 2002
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 25 Jun 2009 (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 purpose of this study is to evaluate the long term use of AutoFlow mode during mechanical ventilation in ICU patients
Detailed description
Many new mechanical ventilation modes are proposed without clinical evaluation. Among them, "dual-controlled" modes, as AutoFlow, are supposed to improve patient-ventilator interfacing, and could led to lesser alarm. This study is a long term clinical evaluation of AutoFlow during assist-controlled ventilation, focusing on its efficacy (on gas exchange and outcome) and on ventilator alarms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With AutoFlow | Experimental | Device: AutoFlow mode on Evita 4 Dräger ventilatorsAssist-controlled ventilation with activation of AutoFlow mode |
| Without AutoFlow | Active comparator | Device: Evita 4 Dräger ventilatorsAssist-controlled ventilation without activation of AutoFlow mode |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients under assist-controlled ventilation with an Evita 4 ventilator (Dräger, France) for an expected duration of more than two days
Key exclusion criteria (3 listed)
- coma
- ventilation longer than 12 hours prior to inclusion
- pregnancy
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 |
|---|---|---|
| AutoFlow mode on Evita 4 Dräger ventilatorsActivation of AutoFlow mode during assist-controlled ventilation | Device | With AutoFlow |
| Evita 4 Dräger ventilatorsAssist-controlled ventilation without activation of AutoFlow mode | Device | Without AutoFlow |
Primary outcome
gas exchange
Time frame: daily during mechanical ventilation
sedation length
Time frame: ICU discharge
ventilator alarm rates
Time frame: daily during mechanical ventilation
5 secondary outcomes
length of mechanical ventilation
Time frame: ICU discharge
ventilator asssociated pneumonia rate
Time frame: ICU discharge
SOFA score
Time frame: daily during mechanical ventilation
death rate
Time frame: ICU discharge
cumulative sedation drugs dosage
Time frame: ICU discharge
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 Jun 2009.
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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.
Hervé MENTEC, MD study director
Centre Hospitalier Victor Dupouy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AutoFlow mode on Evita 4 Dräger ventilators and Evita 4 Dräger ventilators in people with Ventilation, Mechanical, run by Centre Hospitalier Victor Dupouy at 1 site in France.
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 3 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 Jun 2009. 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 France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
gas exchange (time frame: daily during mechanical ventilation). The study lists 3 primary outcomes in all. 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 25 Jun 2009.