Clinical Trials Directory

Trials / Completed

CompletedNCT01489085

Observational Study Evaluating the Use of Intellivent® for Patients With Respiratory Distress Syndrome

Etude Clinique Observationnelle, Prospective, Ouverte, Monocentrique Sur l'Utilisation d'un Mode Ventilatoire entièrement automatisé Chez Les Patients de réanimation de l'Intubation Jusqu'au Sevrage.

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Rational: Intellivent is a ventilation mode completely automated which controls ventilation and oxygenation parameters. Safety and performance of IntelliVent has still been demonstrated in post operative heart surgery for patient with a controlled ventilation on short period (2 to 4 hours). This feasibility study evaluate the use of Intellivent for Intensive care unit patients from intubation to coming off. Primary objective : Compare parameters which have been selected by automated mod (Intellivent) to those selected by clinical practitioner in a conventional mode Secondary objectives: Record oxygenation , gaseous interchange and ventilation parameters. Record complications, number of manual adjustments and prognostic signs. Methodology: Patients in the intensive care unit who need invasive ventilation. They will be included after a detailed information (information note). Oxygenation and ventilation parameters will be recorded 2 times by day from intubation to coming off. The investigator in charge will determine daily at the bedside of the patient the adjustments he should make in a conventional mode. These adjustments will be compared to the IntelliVent automated adjustments. Experimental study, observational, prospective, comparative, opened, monocentric in an intensive care unit. Number of patients: 100

Conditions

Timeline

Start date
2013-01-01
Primary completion
2013-04-01
Completion
2013-04-01
First posted
2011-12-09
Last updated
2014-07-22

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01489085. Inclusion in this directory is not an endorsement.