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(S5-SAMU) Randomized Study Comparing the ASV (Adaptative Support Ventilation) to Conventional Ventilation (S5-SAMU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02348047
Recruitment Status : Terminated (PI resignation)
First Posted : January 28, 2015
Last Update Posted : May 12, 2017
Sponsor:
Collaborator:
Centre Hospitalier Universitaire de Nice
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Device: Hamilton T1 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : March 11, 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2017


Arm Intervention/treatment
Active Comparator: Conventional ventilation
Conventional ventilation - manual mode
Device: Hamilton T1
Experimental: ASV
Intellivent ASV ( Adaptative Support Ventilation )Ventilation- automatic mode
Device: Hamilton T1



Primary Outcome Measures :
  1. Ventilation parameter: VT [ Time Frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours" ]
  2. Ventilation parameter: respiratory rate [ Time Frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours" ]
  3. Ventilation parameters: Fi02 [ Time Frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours" ]
  4. Ventilation parameter: PEEP [ Time Frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours" ]
  5. Ventilation parameter: ETC02 [ Time Frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours" ]

Secondary Outcome Measures :
  1. Numbers of manual adjustments [ Time Frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours" ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348047


Locations
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France
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie
Toulon, France, 83056
Sponsors and Collaborators
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Marilyne ROTI BOUNY, MD Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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Responsible Party: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier: NCT02348047    
Other Study ID Numbers: 2014-CH-01
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases