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

Phase 4

Terminated

• Conditions: Respiratory Distress Syndrome
• Interventions: Device: Hamilton T1

• Registration Number: NCT02348047
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-16
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-28
• Study Start: 2015-03-11
• Primary Completion: 2015-04
• Study Completion: 2017-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional ventilation	Hamilton T1	Conventional ventilation - manual mode
ASV	Hamilton T1	Intellivent ASV ( Adaptative Support Ventilation )Ventilation- automatic mode

Primary Outcome Measures

Name	Time	Method
Ventilation parameter: PEEP	Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Ventilation parameter: ETC02	Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Ventilation parameter: respiratory rate	Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Ventilation parameters: Fi02	Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Ventilation parameter: VT	Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"

Secondary Outcome Measures

Name	Time	Method
Numbers of manual adjustments	Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"

Trial Locations

Locations (1)

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie; 🇫🇷 Toulon, France