Mechanical VentilationNCT00133939
Proportional Ventilation and Ventilatory Synchronism
A study testing Mechanical ventilation in people with Mechanical Ventilation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Synchronism of gas flow delivered by the ventilator and muscular effort of the patient will be studied during two kinds of ventilation. The first one is the proportional assisted ventilation during which the gas flow is theoretically adapted to the patient's muscular effort within the breath. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Mechanical ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing partial ventilatory support
Who cannot join
- Patients failing the weaning process
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital de la Croix-Rousse
Lyon, 69317
Jean-Paul VIALE, MD, PhD, 33 472 072 ext. 426, jean-paul.viale@chu-lyon.fr
Jean-Paul VIALE, MD, PhD
About this study
Synchronism of gas flow delivered by the ventilator and muscular effort of the patient will be studied during two kinds of ventilation. The first one is the proportional assisted ventilation during which the gas flow is theoretically adapted to the patient's muscular effort within the breath. The second is the pressure support ventilation during which the gas flow is delivered to maintain the inspiratory pressure stable. The hypothesis is that the first mode allows a better synchronism.
- Conditions
- Mechanical Ventilation
- Being tested
- Mechanical ventilation
- Keywords
- Proportional assisted ventilation, Pressure support ventilation, Synchronism during mechanical ventilation, Patients undergoing partial mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Time lag between the onset of diaphragmatic electromyogram (EMG) signal and the zero crossing of the inspiratory flow, over five minutes
Secondary outcomes (1)
Number per minute of failing breaths: breath with muscular effort without any inspiratory flow
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Paul VIALE, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133939
- Sponsor's protocol ID
- 2004.359
- Status last verified
- Apr 2007
- First submitted
- 23 Aug 2005
- Last updated
- 27 Apr 2007
- Results posted
- No
Publications
Ganne O, Abisseror M, Menault P, Malhiere S, Chambost V, Charpiat B, Ganne C, Viale JP. Low-dose ketamine failed to spare morphine after a remifentanil-based anaesthesia for ear, nose and throat surgery. Eur J Anaesthesiol. 2005 Jun;22(6):426-30. doi: 10.1017/s0265021505000724.
PubMed 15991504Mechet I, Lhuillier F, Blanchet MC, Pouyet M, Viale JP, Goudable J, Annat G, Scoazec JY, Boillot O, Liotard D, Merle E, Delafosse B. Liver function during extracorporeal whole liver perfusion in a pig model of acute ischemic liver failure. ASAIO J. 2004 Sep-Oct;50(5):503-11. doi: 10.1097/01.mat.0000136509.08283.b9.
PubMed 15497393
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proportional Ventilation and Ventilatory Synchronism
- ClinicalTrials.gov ID
- NCT00133939
- Acronym / sponsor ID
- 2004.359
- Conditions
- Mechanical Ventilation
- Keywords
- Proportional assisted ventilation, Pressure support ventilation, Synchronism during mechanical ventilation, Patients undergoing partial mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- First posted
- 24 Aug 2005 (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.
Synchronism of gas flow delivered by the ventilator and muscular effort of the patient will be studied during two kinds of ventilation. The first one is the proportional assisted ventilation during which the gas flow is theoretically adapted to the patient's muscular effort within the breath. The second is the pressure support ventilation during which the gas flow is delivered to maintain the inspiratory pressure stable. The hypothesis is that the first mode allows a better synchronism.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing partial ventilatory support
Key exclusion criteria (1 listed)
- Patients failing the weaning process
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 |
|---|---|---|
| Mechanical ventilation | Procedure or surgery | – |
Primary outcome
Time lag between the onset of diaphragmatic electromyogram (EMG) signal and the zero crossing of the inspiratory flow, over five minutes
1 secondary outcome
Number per minute of failing breaths: breath with muscular effort without any inspiratory flow
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2007.
- Background: PubMed 15991504Ganne O, Abisseror M, Menault P, Malhiere S, Chambost V, Charpiat B, Ganne C, Viale JP. Low-dose ketamine failed to spare morphine after a remifentanil-based anaesthesia for ear, nose and throat surgery. Eur J Anaesthesiol. 2005 Jun;22(6):426-30. doi: 10.1017/s0265021505000724.
- Background: PubMed 15497393Mechet I, Lhuillier F, Blanchet MC, Pouyet M, Viale JP, Goudable J, Annat G, Scoazec JY, Boillot O, Liotard D, Merle E, Delafosse B. Liver function during extracorporeal whole liver perfusion in a pig model of acute ischemic liver failure. ASAIO J. 2004 Sep-Oct;50(5):503-11. doi: 10.1097/01.mat.0000136509.08283.b9.
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Mechanical Ventilation
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.
Jean-Paul VIALE, MD, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical ventilation in people with Mechanical Ventilation, run by Hospices Civils de Lyon 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 1 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: status not confirmed, as of the sponsor's last update on 27 Apr 2007. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Paul VIALE, MD, PhD (33 472 072 ext. 426, jean-paul.viale@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time lag between the onset of diaphragmatic electromyogram (EMG) signal and the zero crossing of the inspiratory flow, over five minutes. 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 NCT00133939, which also lists 2 linked publications.
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 27 Apr 2007.