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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer.
Recruitment status was  Recruiting
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: January 31, 2013
Last verified: November 2010
History of Changes
  Purpose

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


Condition
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.

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Intensive care Unit intubated Patients

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.
  • Brain dead status.
  • Pregnant woman.
  • Adult under guardianship.
  • Person deprived of liberty
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489085

Locations
France
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Recruiting
Toulon, France, 83056
Contact: jean-michel arnal, ph     0494618098     jean-michel.arnal@ch-toulon.fr    
Sponsors and Collaborators
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Investigators
Principal Investigator: jean-michel arnal, ph Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
  More Information

Publications:

Responsible Party: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier: NCT01489085     History of Changes
Other Study ID Numbers: S1FRTOU-3
Study First Received: December 6, 2011
Last Updated: January 31, 2013
Health Authority: France: French Data Protection Authority

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

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on June 18, 2013