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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05049200
Recruitment Status : Completed
First Posted : September 20, 2021
Last Update Posted : November 1, 2021
Sponsor:
Information provided by (Responsible Party):
Matias Accoce, Sanatorio Anchorena San Martin

Tracking Information
First Submitted Date September 16, 2021
First Posted Date September 20, 2021
Last Update Posted Date November 1, 2021
Actual Study Start Date April 1, 2020
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 28, 2021)
  • weaning rate [ Time Frame: on day 28 ]
    percentage of successfully weaned patients
  • weaning classification [ Time Frame: on day 28 ]
    number of spontaneous breathing tests and days from first spontaneous breathing test to success or death
Original Primary Outcome Measures
 (submitted: September 16, 2021)
  • weaning rate [ Time Frame: april to august ]
    percentage of successfully weaned patients
  • weaning classification [ Time Frame: april to august ]
    number of spontaneous breathing tests and days from first spontaneous breathing test to success or death
Change History
Current Secondary Outcome Measures
 (submitted: October 28, 2021)
  • mechanical ventilation days [ Time Frame: on day 28 ]
    duration of invasive mechanical ventilation
  • length of ICU stay [ Time Frame: on day 28 ]
    days of hospitalization in ICU
Original Secondary Outcome Measures
 (submitted: September 16, 2021)
  • mechanical ventilation days [ Time Frame: april to august ]
    duration of invasive mechanical ventilation
  • length of ICU stay [ Time Frame: april to august ]
    days of hospitalization in ICU
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characteristics of Weaning From Mechanical Ventilation in COVID-19
Official Title Epidemiology of Weaning From Invasive Mechanical Ventilation in COVID-19. Observational and Multicenter Study.
Brief Summary 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.
Detailed Description

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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with a diagnosis of COVID-19 by PCR + and who required invasive mechanical ventilation for more than 12 hours were included.
Condition
  • Respiration, Artificial
  • COVID-19
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 16, 2021)
326
Original Actual Enrollment Same as current
Actual Study Completion Date October 1, 2020
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina
Removed Location Countries  
 
Administrative Information
NCT Number NCT05049200
Other Study ID Numbers 15/16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Matias Accoce, Sanatorio Anchorena San Martin
Original Responsible Party Matias Accoce, Sanatorio Anchorena San Martin, RT
Current Study Sponsor Sanatorio Anchorena San Martin
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Sanatorio Anchorena San Martin
Verification Date October 2021