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

May 11, 2017 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulon, France, 83056
        • Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ventilation parameter: VT
Time Frame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
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"
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"
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"
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"
Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Marilyne ROTI BOUNY, MD, Centre Hospitalier intercommunal de Toulon La Seyne sur Mer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 22, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-CH-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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