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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier:
NCT01489085
First received: December 6, 2011
Last updated: July 21, 2014
Last verified: November 2010

December 6, 2011
July 21, 2014
January 2013
April 2013   (final data collection date for primary outcome measure)
oxygenation , gaseous interchange and ventilation parameters [ Time Frame: Participants are followed until they no longer need ventilation up to 10 days ] [ Designated as safety issue: No ]
Record oxygenation , gaseous interchange and ventilation parameters
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Complete list of historical versions of study NCT01489085 on ClinicalTrials.gov Archive Site
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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.

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

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Intensive care Unit intubated Patients

Respiratory Distress Syndrome
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Arnal JM, Wysocki M, Nafati C, Donati S, Granier I, Corno G, Durand-Gasselin J. Automatic selection of breathing pattern using adaptive support ventilation. Intensive Care Med. 2008 Jan;34(1):75-81. Epub 2007 Sep 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01489085
S1FRTOU-3
Yes
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Not Provided
Principal Investigator: jean-michel arnal, ph Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP