- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05049200
Characteristics of Weaning From Mechanical Ventilation in COVID-19 (CovWean)
Epidemiology of Weaning From Invasive Mechanical Ventilation in COVID-19. Observational and Multicenter Study.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
This report is a multicenter, observational, analytical and prospective study.
Patients older than 18 years with a diagnosis of COVID-19 by PCR + and who required invasive VM for more than 12 hours from April 1 to August 30, 2020 were included. Subjects admitted to pediatric ICUs and in the recovery room were excluded. Patients who were readmitted and required a new cycle of MV after having been successfully weaned and released from the hospital were also excluded. All patients with data loss greater than 10% in variables considered clinically relevant were eliminated.
The weaning process from mechanical ventilation in each patient was classified by two strategies:
Definition of critical care medicine consensus conference published (2007) in:
Simple weaning: Patients successfully extubated after the first weaning attempt.
Difficult weaning: Patients who fail the first weaning attempt and require up to three spontaneous breathing trials or up to 7 days from the first spontaneous breathing trial to achieve a successful weaning.
Prolonged weaning: Patients who fail at least three weaning attempts or require more than 7 days after the first spontaneous breathing trial.
Definition of WIND study:
Group 0 ("no weaning"), made up of patients who never experienced any attempt to wean.
Group 1 (short weaning): the first attempt resulted in the completion of the weaning process in 1 day (successful weaning or early death).
Group 2 (difficult weaning): weaning was completed after more than 1 day but less than 1 week after the first attempt (successful weaning or death).
Group 3 (prolonged weaning): weaning is not yet completed 7 days after the first attempt (due to successful weaning or death).
The first attempt at weaning in intubated patients was considered as the performance of a spontaneous breathing trial with or without extubation, or extubation with or without SBT. In tracheostomized patients, the first period of spontaneous breathing (without ventilatory support) of at least 24 hours duration was considered as the first weaning attempt.
Weaning success was considered when death or re-intubation did not occur after extubation within 7 days or until discharge from the ICU (whichever occurs first), whether or not non-invasive ventilatory support was used. In tracheostomized patients, weaning was considered successful upon reaching seven consecutive days of spontaneous ventilation without ventilatory support or discharge from the ICU, whichever occurs first. [24]
The data were collected by the principal investigator of each center, or by one of the members of the work team designated for the study, preferably between 8:00 am and 11:00 am, recorded on paper sheets and dumped into a database " online "designed in REDCap (Research Electronic Data Capture) with software installed in the Centro del Parque clinic, Buenos Aires, Argentina, guaranteeing the protection and confidentiality of the data in accordance with the Declaration of Helsinki. Data were acquired from the moment of admission to the ICU (once the inclusion criteria and the absence of exclusion criteria had been met) and during the entire follow-up period. All members of the research group provided advice and support through direct telephone contact / e-mail specifically originated for the study.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
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Buenos Aires
-
Pereyra, Buenos Aires, Argentina, 1894
- Matias Accoce
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San Martín, Buenos Aires, Argentina, B1650CQU
- Sanatorio Anchorena de San Martin
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Diagnosis of COVID-19 by PCR +
- Invasive mechanical ventilation for more than 12 hours
Exclusion Criteria:
- Subjects admitted to pediatric ICUs and surgery recovery room.
- Patients who were readmitted and required a new cycle of invasive mechanical ventilation after having been successfully weaned and released from the hospital.
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
weaning rate
Tidsram: on day 28
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percentage of successfully weaned patients
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on day 28
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weaning classification
Tidsram: on day 28
|
number of spontaneous breathing tests and days from first spontaneous breathing test to success or death
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on day 28
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
mechanical ventilation days
Tidsram: on day 28
|
duration of invasive mechanical ventilation
|
on day 28
|
length of ICU stay
Tidsram: on day 28
|
days of hospitalization in ICU
|
on day 28
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
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- Marini JJ, Gattinoni L. Management of COVID-19 Respiratory Distress. JAMA. 2020 Jun 9;323(22):2329-2330. doi: 10.1001/jama.2020.6825. No abstract available.
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- Cabello B, Thille AW, Roche-Campo F, Brochard L, Gomez FJ, Mancebo J. Physiological comparison of three spontaneous breathing trials in difficult-to-wean patients. Intensive Care Med. 2010 Jul;36(7):1171-9. doi: 10.1007/s00134-010-1870-0. Epub 2010 Mar 30.
- Ranzani OT, Bastos LSL, Gelli JGM, Marchesi JF, Baiao F, Hamacher S, Bozza FA. Characterisation of the first 250,000 hospital admissions for COVID-19 in Brazil: a retrospective analysis of nationwide data. Lancet Respir Med. 2021 Apr;9(4):407-418. doi: 10.1016/S2213-2600(20)30560-9. Epub 2021 Jan 15.
- Estenssoro E, Loudet CI, Rios FG, Kanoore Edul VS, Plotnikow G, Andrian M, Romero I, Piezny D, Bezzi M, Mandich V, Groer C, Torres S, Orlandi C, Rubatto Birri PN, Valenti MF, Cunto E, Saenz MG, Tiribelli N, Aphalo V, Reina R, Dubin A; SATI-COVID-19 Study Group. Clinical characteristics and outcomes of invasively ventilated patients with COVID-19 in Argentina (SATICOVID): a prospective, multicentre cohort study. Lancet Respir Med. 2021 Sep;9(9):989-998. doi: 10.1016/S2213-2600(21)00229-0. Epub 2021 Jul 2.
- Karagiannidis C, Mostert C, Hentschker C, Voshaar T, Malzahn J, Schillinger G, Klauber J, Janssens U, Marx G, Weber-Carstens S, Kluge S, Pfeifer M, Grabenhenrich L, Welte T, Busse R. Case characteristics, resource use, and outcomes of 10 021 patients with COVID-19 admitted to 920 German hospitals: an observational study. Lancet Respir Med. 2020 Sep;8(9):853-862. doi: 10.1016/S2213-2600(20)30316-7. Epub 2020 Jul 28.
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- Morandi A, Brummel NE, Ely EW. Sedation, delirium and mechanical ventilation: the 'ABCDE' approach. Curr Opin Crit Care. 2011 Feb;17(1):43-9. doi: 10.1097/MCC.0b013e3283427243.
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