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Clinical Trials/NCT01489085
NCT01489085
Completed
N/A

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.

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer1 site in 1 country100 target enrollmentJanuary 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Respiratory Distress Syndrome
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Enrollment
100
Locations
1
Primary Endpoint
oxygenation , gaseous interchange and ventilation parameters
Status
Completed
Last Updated
11 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
April 2013
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

Study Sites (1)

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