Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Characteristics of Weaning From Mechanical Ventilation in COVID-19 (CovWean)

28 oktober 2021 uppdaterad av: Matias Accoce, Sanatorio Anchorena San Martin

Epidemiology of Weaning From Invasive Mechanical Ventilation in COVID-19. Observational and Multicenter Study.

This report is a multicenter, observational, analytical and prospective study. The objective was to describe the weaning of mechanical ventilation in patients with SARS-CoV-2 and the clinical results according to the different types of weaning.

Studieöversikt

Status

Avslutad

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

Observationell

Inskrivning (Faktisk)

326

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Buenos Aires
      • Pereyra, Buenos Aires, Argentina, 1894
        • Matias Accoce
      • San Martín, Buenos Aires, Argentina, B1650CQU
        • Sanatorio Anchorena de San Martin

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients with a diagnosis of COVID-19 by PCR + and who required invasive mechanical ventilation for more than 12 hours were included.

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
weaning rate
Tidsram: on day 28
percentage of successfully weaned patients
on day 28
weaning classification
Tidsram: on day 28
number of spontaneous breathing tests and days from first spontaneous breathing test to success or death
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

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 april 2020

Primärt slutförande (Faktisk)

31 augusti 2020

Avslutad studie (Faktisk)

1 oktober 2020

Studieregistreringsdatum

Först inskickad

16 september 2021

Först inskickad som uppfyllde QC-kriterierna

16 september 2021

Första postat (Faktisk)

20 september 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 november 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 oktober 2021

Senast verifierad

1 oktober 2021

Mer information

Termer relaterade till denna studie

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Covid-19

3
Prenumerera