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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02348047 |
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Date of registration:
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16/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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(S5-SAMU) Randomized Study Comparing the ASV (Adaptative Support Ventilation) to Conventional Ventilation
S5-SAMU |
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Scientific title:
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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 |
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Date of first enrolment:
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March 11, 2015 |
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Target sample size:
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27 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02348047 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Marilyne ROTI BOUNY, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Intubation
- Secondary transfer (interhospital)
- Informed patients / close relations, signed consent
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Respiratory Distress Syndrome
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Intervention(s)
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Device: Hamilton T1
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Primary Outcome(s)
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Ventilation parameter: ETC02
[Time Frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"]
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Ventilation parameter: PEEP
[Time Frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"]
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Ventilation parameter: respiratory rate
[Time Frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"]
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Ventilation parameter: VT
[Time Frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"]
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Ventilation parameters: Fi02
[Time Frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"]
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Secondary Outcome(s)
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Numbers of manual adjustments
[Time Frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"]
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Secondary ID(s)
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2014-CH-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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