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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01489085

Acronym

intellivent

Enrollment

100

Registered

2011-12-09

Start date

2013-01-31

Completion date

2013-04-30

Last updated

2014-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome

Keywords

ventilation, automated

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
oxygenation , gaseous interchange and ventilation parameters	Participants are followed until they no longer need ventilation up to 10 days	Record oxygenation , gaseous interchange and ventilation parameters

Countries

France

Outcome results