Observational Study Evaluating the Use of Intellivent® for Patients With Respiratory Distress Syndrome (intellivent)
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
Respiratory Distress Syndrome
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||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.|
- oxygenation , gaseous interchange and ventilation parameters [ Time Frame: Participants are followed until they no longer need ventilation up to 10 days ] [ Designated as safety issue: No ]Record oxygenation , gaseous interchange and ventilation parameters
|Study Start Date:||January 2013|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489085
|Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer|
|Toulon, France, 83056|
|Principal Investigator:||jean-michel arnal, ph||Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer|