Clinical trial NCT01489085: Observational Study Evaluating the Use of Intellivent® for Patients With Respiratory Distress Syndrome
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome
Keywords: ventilation
automated
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2011-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care Unit intubated Patients

Brief 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


Eligibility criteria: Inclusion Criteria:

* Patient which needs an invasive ventilation
* Intubation \< 24 hours
* Age ≥ 18 years

Exclusion Criteria:

* Patient which has withdrawal standard in line with the unit coming off procedure (all criteria must be present)
* temperature ≤ 38,5°C
* No pressor drug
* No sedation,
* Motor response to order,
* Cough during bronchoaspiration
* %VM ≤ 130%, FiO2 ≤ 50%, PEEP ≤ 5 cmH2O, Pinsp ≤ 25 cmH2O.
* Patient with non invasive ventilation .
* Dysfunctions of the ventilatory command (ex Cheyne-Stokes).
* Broncho pleural fistula.
* Brain dead status.
* Pregnant woman.
* Adult under guardianship.
* Person deprived of liberty

Primary outcomes:
measure: oxygenation , gaseous interchange and ventilation parameters
timeFrame: Participants are followed until they no longer need ventilation up to 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Study officials:
affiliation: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
name: jean-michel arnal, ph
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnal JM, Wysocki M, Nafati C, Donati S, Granier I, Corno G, Durand-Gasselin J. Automatic selection of breathing pattern using adaptive support ventilation. Intensive Care Med. 2008 Jan;34(1):75-81. doi: 10.1007/s00134-007-0847-0. Epub 2007 Sep 11.
citation: Arnal JM, Garnero A, Novonti D, Demory D, Ducros L, Berric A, Donati S, Corno G, Jaber S, Durand-Gasselin J. Feasibility study on full closed-loop control ventilation (IntelliVent-ASV) in ICU patients with acute respiratory failure: a prospective observational comparative study. Crit Care. 2013 Sep 11;17(5):R196. doi: 10.1186/cc12890.