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OpenTrials
Completed

NCT Number: NCT05954351

PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients.

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.

Completed

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Key information

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. ICU mortality

    Time frame: 90 days from inclusion

Secondary outcomes

  1. Duration of ventilation

    Time frame: 90 days from inclusion

  2. 28-day ventilator free days

    Time frame: 90 days from inclusion

  3. 28-day, 90-day mortality

    Time frame: 90 days from inclusion

  4. ICU and hospital length of stay

    Time frame: 90 days from inclusion

Other outcomes

  1. Acute kidney injury

    Time frame: 90 days from inclusion

  2. duration of ventilation in survivors

    Time frame: 90 days from inclusion

  3. use of muscle paralysis

    Time frame: 90 days from inclusion

  4. vasopressor or inotrope administration

    Time frame: 90 days from inclusion

  5. occurrence of tracheostomy

    Time frame: 90 days from inclusion

  6. pneumothorax and thromboembolic complications

    Time frame: 90 days from inclusion

  7. use of immunomodulating drugs

    Time frame: 90 days from inclusion

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients; What is the Optimal Ventilation Strategy in Critically Ill COVID-19 Patients, in Particular PEEP and the Moment of Switch to Pressure Support?

Acronym: PRoVAcT-COVID

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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