- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01489085
Observational Study Evaluating the Use of Intellivent® for Patients With Respiratory Distress Syndrome (intellivent)
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
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Toulon, Frankrig, 83056
- Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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oxygenation , gaseous interchange and ventilation parameters
Tidsramme: Participants are followed until they no longer need ventilation up to 10 days
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Record oxygenation , gaseous interchange and ventilation parameters
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Participants are followed until they no longer need ventilation up to 10 days
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: jean-michel arnal, ph, Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
Publikationer og nyttige links
Generelle publikationer
- 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. doi: 10.1007/s00134-007-0847-0. Epub 2007 Sep 11.
- Arnal JM, Garnero A, Novonti D, Demory D, Ducros L, Berric A, Donati S, Corno G, Jaber S, Durand-Gasselin J. Feasibility study on full closed-loop control ventilation (IntelliVent-ASV) in ICU patients with acute respiratory failure: a prospective observational comparative study. Crit Care. 2013 Sep 11;17(5):R196. doi: 10.1186/cc12890.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- S1FRTOU-3
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