Observational Study Evaluating the Use of Intellivent® for Patients With Respiratory Distress Syndrome (intellivent)
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|ClinicalTrials.gov Identifier: NCT01489085|
Recruitment Status : Completed
First Posted : December 9, 2011
Last Update Posted : July 22, 2014
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
|Condition or disease|
|Respiratory Distress Syndrome|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|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.|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
- oxygenation , gaseous interchange and ventilation parameters [ Time Frame: Participants are followed until they no longer need ventilation up to 10 days ]Record oxygenation , gaseous interchange and ventilation parameters
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|