NCT02348047

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 11, 2015

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

21 days

First QC Date

January 16, 2015

Last Update Submit

May 11, 2017

Conditions

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (5)

  • Ventilation parameter: VT

    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: 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"

Secondary Outcomes (1)

  • Numbers of manual adjustments

    Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"

Study Arms (2)

Conventional ventilation

ACTIVE COMPARATOR

Conventional ventilation - manual mode

Device: Hamilton T1

ASV

EXPERIMENTAL

Intellivent ASV ( Adaptative Support Ventilation )Ventilation- automatic mode

Device: Hamilton T1

Interventions

Hamilton T1DEVICE
ASVConventional ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intubation
  • Secondary transfer (interhospital)
  • Informed patients / close relations, signed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Toulon, 83056, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Marilyne ROTI BOUNY, MD

    Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 28, 2015

Study Start

March 11, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2017

Last Updated

May 12, 2017

Record last verified: 2017-05

Locations

FR(1)