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

Respiratory Distress Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02348047
• Other study ID #: 2014-CH-01
• Status: Terminated
• Phase: Phase 4
• First received: January 16, 2015
• Last updated: May 11, 2017
• Start date: March 11, 2015
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: April 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Hamilton T1

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie	Toulon

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer	Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilation parameter: VT		Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Primary	Ventilation parameter: respiratory rate		Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Primary	Ventilation parameters: Fi02		Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Primary	Ventilation parameter: PEEP		Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Primary	Ventilation parameter: ETC02		Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Secondary	Numbers of manual adjustments		Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"