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

This study has been completed.
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Identifier:
First received: December 6, 2011
Last updated: July 21, 2014
Last verified: November 2010

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

Respiratory Distress Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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.

Resource links provided by NLM:

Further study details as provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer:

Primary Outcome Measures:
  • 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

Enrollment: 100
Study Start Date: January 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intensive care Unit intubated Patients

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
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Please refer to this study by its identifier: NCT01489085

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Toulon, France, 83056
Sponsors and Collaborators
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Principal Investigator: jean-michel arnal, ph Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Identifier: NCT01489085     History of Changes
Other Study ID Numbers: S1FRTOU-3
Study First Received: December 6, 2011
Last Updated: July 21, 2014

Keywords provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer:

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases processed this record on May 25, 2017