NCT05954351

Brief Summary

PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients. An observational study of ventilation practice and adjunctive therapies in critically ill, invasively ventilated COVID-19 patients during the first and second surge of COVID-19 in the Netherlands.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,465

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

1.2 years

First QC Date

July 19, 2023

Last Update Submit

July 1, 2024

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • ICU mortality

    90 days from inclusion

Secondary Outcomes (4)

  • Duration of ventilation

    90 days from inclusion

  • 28-day ventilator free days

    90 days from inclusion

  • 28-day, 90-day mortality

    90 days from inclusion

  • ICU and hospital length of stay

    90 days from inclusion

Other Outcomes (7)

  • Acute kidney injury

    90 days from inclusion

  • duration of ventilation in survivors

    90 days from inclusion

  • use of muscle paralysis

    90 days from inclusion

  • +4 more other outcomes

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

invasively ventilation COVID-19 patients, admitted between March 1 to June 1, 2020, and October 1 to December 31, 2020, to one of the 22 participating ICU's in the Netherlands.

You may qualify if:

  • receiving invasive ventilation or high-flow nasal oxygen for COVID-19 for SARS-CoV-2
  • admitted to one of the ICUs of the participating hospitals

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. Marcus J. Schultz

Study Record Dates

First Submitted

July 19, 2023

First Posted

July 20, 2023

Study Start

May 1, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

NL(1)