Back to results(S5-SAMU) Randomized Study Comparing the ASV (Adaptative Support Ventilation) to Conventional Ventilation (S5-SAMU)
Primary Purpose
Respiratory Distress Syndrome
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Hamilton T1
Sponsored by
About this trial
This is an interventional supportive care trial for Respiratory Distress Syndrome
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional ventilation
ASV
Arm Description
Conventional ventilation - manual mode
Intellivent ASV ( Adaptative Support Ventilation )Ventilation- automatic mode
Outcomes
Primary Outcome Measures
Ventilation parameter: VT
Ventilation parameter: respiratory rate
Ventilation parameters: Fi02
Ventilation parameter: PEEP
Ventilation parameter: ETC02
Secondary Outcome Measures
Numbers of manual adjustments
Full Information
NCT ID
NCT02348047
First Posted
January 16, 2015
Last Updated
May 11, 2017
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT02348047
Brief Title
(S5-SAMU) Randomized Study Comparing the ASV (Adaptative Support Ventilation) to Conventional Ventilation
Acronym
S5-SAMU
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
PI resignation
Study Start Date
March 11, 2015 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional ventilation
Arm Type
Active Comparator
Arm Description
Conventional ventilation - manual mode
Arm Title
ASV
Arm Type
Experimental
Arm Description
Intellivent ASV ( Adaptative Support Ventilation )Ventilation- automatic mode
Intervention Type
Device
Intervention Name(s)
Hamilton T1
Primary Outcome Measure Information:
Title
Ventilation parameter: VT
Time Frame
Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Title
Ventilation parameter: respiratory rate
Time Frame
Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Title
Ventilation parameters: Fi02
Time Frame
Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Title
Ventilation parameter: PEEP
Time Frame
Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Title
Ventilation parameter: ETC02
Time Frame
Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Secondary Outcome Measure Information:
Title
Numbers of manual adjustments
Time Frame
Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyne ROTI BOUNY, MD
Organizational Affiliation
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie
City
Toulon
ZIP/Postal Code
83056
Country
France
12. IPD Sharing Statement
Learn more about this trial
(S5-SAMU) Randomized Study Comparing the ASV (Adaptative Support Ventilation) to Conventional Ventilation
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