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

Completed

• Conditions: Respiratory Distress Syndrome

• Registration Number: NCT01489085
• Lead Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-11
• Study First Submitted: 2011-12-06
• Study First Submitted QC: 2011-12-08
• Study First Posted: 2011-12-09
• Study Start: 2013-01
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2014-07-21
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer; 🇫🇷 Toulon, France