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

Intermunicipal Hospital Center Toulon

Status: Completed

Conditions: Respiratory Distress Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT01489085

S1FRTOU-3

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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