Artificial RespirationPhase 2/3ORGARNCT00700869
Evaluation of a New Mechanical Ventilation Weaning Strategy for Patients With Altered Level of Consciousness
A Phase 2/3 study testing mechanical ventilation in people with Artificial Respiration and Consciousness Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine if a weaning strategy from artificial ventilation governs by respiratory behaviour status assessed by our method is safe enough. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Artificial Respiration, Consciousness Disorders, Wearing Off Effect
- What is being tested?
- mechanical ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2008to Sep 2011
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Altered level of consciousness (-1 < RASS > +1)
- Mechanical ventilation ( > 72 hours)
- Withdrawal of sedative drugs (> 48 hours)
- T tube challenge tolerance
- Signed approval for the study by close relative or legal representative
Who cannot join
- Respiratory disease prior to the actual artificial ventilation requirement.
- Impairment of upper airway function prior to the actual artificial ventilation requirement.
- Pregnancy
- Minor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of a New Mechanical Ventilation Weaning Strategy Governs by a Respiratory Behaviour Status Assessment for Patients With Altered Level of Consciousness
The purpose of this study is to determine if a weaning strategy from artificial ventilation governs by respiratory behaviour status assessed by our method is safe enough.
Read the detailed description
Current guidelines for mechanical ventilation weaning do not apply for patients with altered level of consciousness. One major limitation is a failure of clinical assessment of the respiratory behaviour status of these patients that are not able to interact appropriately with the examiner. We propose a non-invasive method for the respiratory behaviour assessment of a patient under artificial ventilation that do not requires his participation. Our hypothesis is that, in case of normal respiratory behaviour status, it is possible to wean under security a patient despite his abnormal level of consciousness.We previously demonstrate that patients successfully wean by the clinical team also disclose a normal respiratory behaviour status while patients with weaning failure had abnormal respiratory behaviour. In the present study, we wonder to evaluate that a weaning strategy governs by respiratory behaviour status assessed by our method is safe. For this purpose, in this study, tracheal tube withdrawal is triggered by a recognition of a normal respiratory behaviour status assessed daily in patients under mechanical ventilation with an altered level of consciousness and a good tolerance to T tube challenge.
- Being tested
- mechanical ventilation
- Keywords
- Altered level of consciousness, Tracheal tube withdrawal, Respiration, Artificial Respiration, Physiology
- Medical subject headings
- Consciousness Disorders, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilationProcedure or surgery
mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tracheal tube withdrawal governs by respiratory behaviour status Receives: Procedure: mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful mechanical ventilation weaning at 72 hours
Measured: 72 hours
Secondary outcomes (2)
Post tracheal tube withdrawal pneumonia at 72 hours
Measured: 72 hours
Rate of auto-extubation during patient's participation to the protocol
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial RespirationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent HEYER, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700869
- Sponsor's protocol ID
- P070204
- Acronym
- ORGAR
- Status last verified
- Sep 2011
- First submitted
- 18 Jun 2008
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of a New Mechanical Ventilation Weaning Strategy Governs by a Respiratory Behaviour Status Assessment for Patients With Altered Level of Consciousness
- ClinicalTrials.gov ID
- NCT00700869
- Acronym / sponsor ID
- ORGAR / P070204
- Keywords
- Altered level of consciousness, Tracheal tube withdrawal, Respiration, Artificial Respiration, Physiology
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Jun 2008 (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 determine if a weaning strategy from artificial ventilation governs by respiratory behaviour status assessed by our method is safe enough.
Detailed description
Current guidelines for mechanical ventilation weaning do not apply for patients with altered level of consciousness. One major limitation is a failure of clinical assessment of the respiratory behaviour status of these patients that are not able to interact appropriately with the examiner. We propose a non-invasive method for the respiratory behaviour assessment of a patient under artificial ventilation that do not requires his participation. Our hypothesis is that, in case of normal respiratory behaviour status, it is possible to wean under security a patient despite his abnormal level of consciousness.We previously demonstrate that patients successfully wean by the clinical team also disclose a normal respiratory behaviour status while patients with weaning failure had abnormal respiratory behaviour. In the present study, we wonder to evaluate that a weaning strategy governs by respiratory behaviour status assessed by our method is safe. For this purpose, in this study, tracheal tube withdrawal is triggered by a recognition of a normal respiratory behaviour status assessed daily in patients under mechanical ventilation with an altered level of consciousness and a good tolerance to T tube challenge.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: mechanical ventilationTracheal tube withdrawal governs by respiratory behaviour status |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Altered level of consciousness (-1 < RASS > +1)
- Mechanical ventilation ( > 72 hours)
- Withdrawal of sedative drugs (> 48 hours)
- T tube challenge tolerance
- Signed approval for the study by close relative or legal representative
Key exclusion criteria (4 listed)
- Respiratory disease prior to the actual artificial ventilation requirement.
- Impairment of upper airway function prior to the actual artificial ventilation requirement.
- Pregnancy
- Minor
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 ventilationmechanical ventilation | Procedure or surgery | 1 |
Primary outcome
Rate of successful mechanical ventilation weaning at 72 hours
Time frame: 72 hours
2 secondary outcomes
Post tracheal tube withdrawal pneumonia at 72 hours
Time frame: 72 hours
Rate of auto-extubation during patient's participation to the protocol
Time frame: 10 days
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 5 Oct 2011.
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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.
Laurent HEYER, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing mechanical ventilation in people with Artificial Respiration and Consciousness Disorders, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 4 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 5 Oct 2011. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Rate of successful mechanical ventilation weaning at 72 hours (time frame: 72 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 5 Oct 2011.