- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00678912
Weaning Children From Mechanical Ventilation:Computer-driven System Versus Usual Care
Single Center Randomized Clinical Trial Comparing Weaning From Mechanical Ventilation With Computer-driven System vs Usual Care in Children
Studieoversikt
Detaljert beskrivelse
Baseline data: All subjects included into this RCT will undergo routine examination upon admission to the hospital. These examinations include physical, medical/medication history (on the last year for medical history and the last 3 months for medication history (if available), vital signs, radiologic data and laboratory tests.
Intervention: A pre-inclusion test (pressure support test) with a level of pressure support of ± 5 cmH2O of the P plateau, but no greater than 30 cmH2O (pressure-support level plus positive end-expiratory pressure), is performed to evaluate the patient's tolerance of this ventilation mode; the test is repeated daily until positive. The test could be stopped before 30 minutes if the patient showed evidence of respiratory distress (respiratory rate > 40 breaths per minute and FiO2 > 60% in order to obtain pulse oxymetry ≥ 95%). The test is considered positive when, after 30 minutes, the patient remained clinically stable with a respiratory rate lower than 40 breaths per minute and an expiratory tidal volume higher than 6 ml per kilogram of body weight within the authorized pressure-support range, with pulse oxymetry no lower than 95 percent when the fraction of inspired oxygen was no greater than 60 percent. When the pressure-support test is positive, the patient is randomized either to Arm 1 where the intervention is weaning with the support of Smartcare/PS or to Arm 2 where the intervention is weaning based on usual care. Both group are ventilated with the same ventilator: Evita XL.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1C5
- CHU Sainte Justine
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- The attending physician thinks that the patient will be able to breathe spontaneously or the patients is already breathing spontaneously.
- No vasopressor or inotropic medication, unless the patient is receiving some digitalin or small doses of dopamine (< 5 µg/kg/min)
- Slight or no endotracheal tube gas-leakage ([Vti - Vte]/Vti ≤ 20%)
- Mechanical ventilation with a plateau pressure ≤ 25 cmH2O over PEEP
- PEEP ≤ 8 cmH2O
- FiO2 ≤ 60% in order to obtain pulse oxymetry ≥ 95%
- PaCO2 < 70 mmHg on the last blood gases
- Extubation not expected the day of inclusion
Exclusion Criteria:
- N/A
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1
Children are mechanically ventilated with Smartcare/PS
|
computer-driven protocol that adjusts pressure support level in pressure support mode to patient respiratory status
Andre navn:
|
Ingen inngripen: 2
Children are mechanically ventilated with usual care
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Length of weaning from mechanical ventilation that corresponds to the time from Time 0 to the first extubation.
Tidsramme: first extubation or 28 days
|
first extubation or 28 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Total mechanical ventilation duration
Tidsramme: first extubation or 28 days
|
first extubation or 28 days
|
Proportion of time in the acceptable breathing zone
Tidsramme: first extubation or 28 days
|
first extubation or 28 days
|
Weaning failure
Tidsramme: 48 hours after first extubation
|
48 hours after first extubation
|
Number of interventions on the ventilator by a physician or physiotherapist
Tidsramme: First extubation or 28 days
|
First extubation or 28 days
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Philippe A Jouvet, MD PhD, Université de Montréal
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Jouvet P, Farges C, Hatzakis G, Monir A, Lesage F, Dupic L, Brochard L, Hubert P. Weaning children from mechanical ventilation with a computer-driven system (closed-loop protocol): a pilot study. Pediatr Crit Care Med. 2007 Sep;8(5):425-32. doi: 10.1097/01.PCC.0000282157.77811.F9.
- Jouvet PA, Payen V, Gauvin F, Emeriaud G, Lacroix J. Weaning children from mechanical ventilation with a computer-driven protocol: a pilot trial. Intensive Care Med. 2013 May;39(5):919-25. doi: 10.1007/s00134-013-2837-8. Epub 2013 Jan 30.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CHUSJ-2239
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