Respiratory Distress SyndromePhase 4S5-SAMUNCT02348047
(S5-SAMU) Randomized Study Comparing the ASV (Adaptative Support Ventilation) to Conventional Ventilation
A Phase 4 study testing Hamilton T1 in people with Respiratory Distress Syndrome, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial summary
Compare ventilation parameters in Adaptative Support Ventilation mode to conventional mode, on intubated, ventilated and sedated patients, during their secondary transfer from an hospital to another, by a SMUR team. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Hamilton T1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2015to Apr 2017
- 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
- Intubation
- Secondary transfer (interhospital)
- Informed patients / close relations, signed consent
Who cannot join
- Primary transport of a ventilated, intubated, sedated patient
- Patient in limitation and stop of active therapeutics, dying person
- Broncho pleural fistula
- Patient under ECMO
- Patient included in another research submitted to consent
- Supervision, loss of liberty
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie
Toulon, 83056
About this study
Official title: Randomized Study Comparing the ASV to Conventional Ventilation for Intubated Patients During Inter-hospital Transfers. Controlled Randomized Monocentric Prospective Study Comparing ASV Versus Conventional Ventilation Modes
Compare ventilation parameters in Adaptative Support Ventilation mode to conventional mode, on intubated, ventilated and sedated patients, during their secondary transfer from an hospital to another, by a SMUR team.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Hamilton T1
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hamilton T1Device
| Study group | Role | What they receive |
|---|---|---|
| Conventional ventilation | Active comparator | Conventional ventilation - manual mode Receives: Device: Hamilton T1 |
| ASV | Experimental | Intellivent ASV ( Adaptative Support Ventilation )Ventilation- automatic mode Receives: Device: Hamilton T1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation parameter: VT
Measured: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Ventilation parameter: respiratory rate
Measured: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Ventilation parameters: Fi02
Measured: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Ventilation parameter: PEEP
Measured: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Ventilation parameter: ETC02
Measured: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Secondary outcomes (1)
Numbers of manual adjustments
Measured: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study start11 Mar 2015
- Primary completionApr 2015
- Study completionApr 2017
Why it stopped: PI resignation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice
- Responsible party
- Sponsor
- Investigators
- Marilyne ROTI BOUNY, MD, Principal investigator, Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348047
- Sponsor's protocol ID
- 2014-CH-01
- Acronym
- S5-SAMU
- Status last verified
- May 2017
- First submitted
- 16 Jan 2015
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing the ASV to Conventional Ventilation for Intubated Patients During Inter-hospital Transfers. Controlled Randomized Monocentric Prospective Study Comparing ASV Versus Conventional Ventilation Modes
- ClinicalTrials.gov ID
- NCT02348047
- Acronym / sponsor ID
- S5-SAMU / 2014-CH-01
- Conditions
- Respiratory Distress Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI resignation
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice
- Study start
- 11 Mar 2015 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 28 Jan 2015 (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.
Compare ventilation parameters in Adaptative Support Ventilation mode to conventional mode, on intubated, ventilated and sedated patients, during their secondary transfer from an hospital to another, by a SMUR team.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ventilation | Active comparator | Device: Hamilton T1Conventional ventilation - manual mode |
| ASV | Experimental | Device: Hamilton T1Intellivent ASV ( Adaptative Support Ventilation )Ventilation- automatic mode |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intubation
- Secondary transfer (interhospital)
- Informed patients / close relations, signed consent
Key exclusion criteria (7 listed)
- Primary transport of a ventilated, intubated, sedated patient
- Patient in limitation and stop of active therapeutics, dying person
- Broncho pleural fistula
- Patient under ECMO
- Patient included in another research submitted to consent
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 T1 | Device | ASV, Conventional ventilation |
Primary outcome
Ventilation parameter: VT
Time frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Ventilation parameter: respiratory rate
Time frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Ventilation parameters: Fi02
Time frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Ventilation parameter: PEEP
Time frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Ventilation parameter: ETC02
Time frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
1 secondary outcome
Numbers of manual adjustments
Time frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Results and safety
The study was stopped early (reason given: PI resignation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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.
Marilyne ROTI BOUNY, MD principal investigator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
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 Hamilton T1 in people with Respiratory Distress Syndrome, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 12 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 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 was stopped early (reason given: PI resignation). Results are not available in the source record.
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?
Ventilation parameter: VT (time frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"). The study lists 5 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 12 May 2017; AzTrials last refreshed its copy on 28 Oct 2026.