PRactice of VENTilation in COVID-19 Patients (PRoVENT-COVID)

COVID Clinical Trial

— PRoVENT-COVID  

Official title:

PRactice of VENTilation in COVID-19 Patients (PRoVENT-COVID) - an Observational Study of Invasively Ventilated Patients in the Netherlands

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04346342
• Other study ID #: PRoVENT-COVID
• Status: Completed
• Start date: March 6, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: July 2021
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this national, multicenter service review is to determine and compare ventilation management in COVID-19 patients in the Netherlands, and to determine whether certain ventilation settings have an independent association with duration of ventilation.

In every adult invasively ventilated COVID-19 patient from a participating ICU, granular ventilator settings and parameters will be collected from start of invasive ventilation for up to 72 hours. Follow up is until ICU and hospital discharge, and until day 90. The primary outcome includes main ventilator settings (including tidal volume, airway pressures, oxygen fraction and respiratory rate). Secondary endpoints are ventilator-free days and alive at day 28 (VFD-28); duration of mechanical ventilation; use of prone positioning and recruitment maneuvers; duration of ICU and hospital stay; incidence of kidney injury; and ICU, hospital, 28-day and 90-day mortality.

Description:

Rationale:

The novel coronavirus disease (COVID-19) pandemic is rapidly expanding across the world, with over 60.000 new cases each day as of late March 2020. Healthcare workers are struggling to provide the best care for patients with proven or suspected COVID-19. Approaches for clinical care vary widely between and within countries and new insights are acquired rapidly. This includes the way invasive ventilation is applied.

Objective:

To determine and compare invasive ventilation settings and parameters in COVID-19 patients in the Netherlands, and to determine associations with clinical outcomes.

Hypotheses:

Invasive ventilation settings and parameters vary between intensive care units (ICUs) in hospitals in the Netherlands; certain ventilator settings have an independent association with duration of ventilation in COVID-19 patients.

Study design:

Multicenter, national, retrospective, observational study in COVID-19 patients with respiratory failure, requiring invasive ventilation in intensive care unit (ICU) in hospitals in the Netherlands.

Study population:

The data of at least 1,000 consecutively invasively ventilated COVID-19 patients admitted to intensive care units (ICUs) of hospitals in the Netherlands. This study will not be restricted to the 'formal' ICUs, as patients may also receive invasive ventilation in other locations within the hospital during the COVID-19 pandemic.

Methods:

In every patient, granular ventilator settings and parameters are collected from start of invasive ventilation for up to 72 hours. Patients will be followed up until ICU and hospital discharge, and until day 90.

Sample size calculation:

No formal sample size calculation is needed. We expect to capture at least 1,000 patients, but will continue collecting data of new patients for at least 8 weeks.

Study endpoints:

Main ventilator settings (including tidal volume, airway pressures, oxygen fraction and respiratory rate) (primary) and parameters (blood gas results); use of rescue therapies (including prone positioning); use of sedatives, vasopressors and inotropes; daily cumulative fluid balances; development of kidney injury; ventilator-free days and alive at day 28 (VFD-28), duration of ICU and hospital stay, and ICU, hospital and 90-day mortality.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Retrospective collection of data regarding ventilation management and major clinical endpoints is without risk for the individual patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1122
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• COVID-19, confirmed with polymerase chain reaction (PCR) and/or presence of typical abnormalities on chest computer tomography (CT)

• Suspected COVID-19 infection, with no exclusion of diagnosis

• Having received invasive ventilation

Exclusion Criteria:

• Age <18 years

• Already included in the same study in another hospital

• Having had received invasive ventilation > 24 hours in a non-participating hospital

Related Conditions & MeSH terms

• Acute Respiratory Failure
• COVID
• Mechanical Ventilation
• Respiratory Insufficiency

Locations

Country	Name	City	State
Netherlands	Flevoziekenhuis	Almere
Netherlands	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Gelre ziekenhuizen	Apeldoorn
Netherlands	Rijnstate Ziekenhuis	Arnhem
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Reinier de Graaf Gasthuis	Delft
Netherlands	Haaglanden Medisch Centrum	Den Haag
Netherlands	HagaZiekenhuis	Den Haag
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Maxima Medical Center	Eindhoven
Netherlands	St Anna Ziekenhuis	Geldrop
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Spaarne Gasthuis	Haarlem
Netherlands	Dijklander Ziekenhuis	Hoorn
Netherlands	Leeuwarden Medisch Centrum	Leeuwarden
Netherlands	Maastricht Universitair Medisch Centrum	Maastricht
Netherlands	St Antonius Ziekenhuis	Nieuwegein
Netherlands	Maasstad Hospital	Rotterdam
Netherlands	Zuyderland Medisch Centrum	Sittard
Netherlands	Isala Ziekenhuis	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilation Mode		Day 1 to Day 3 from initiation of mechanical ventilation
Primary	Tidal volume set		Day 1 to Day 3 from initiation of mechanical ventilation
Primary	Expiratory tidal volume		Day 1 to Day 3 from initiation of mechanical ventilation
Primary	Positive end-expiratory pressure		Day 1 to Day 3 from initiation of mechanical ventilation
Primary	Maximum airway pressure or plateau pressure (P plateau) or peak pressure (P peak) (cm H2O);		Day 1 to Day 3 from initiation of mechanical ventilation
Primary	Level of pressure support above positive end-expiratory pressure (PEEP)		Day 1 to Day 3 from initiation of mechanical ventilation
Primary	Inspired fraction of oxygen		Day 1 to Day 3 from initiation of mechanical ventilation
Primary	Set and measured respiratory rate		Day 1 to Day 3 from initiation of mechanical ventilation
Primary	Inspiration to expiration ratio		Day 1 to Day 3 from initiation of mechanical ventilation
Secondary	Number of ventilation-free days and alive at day 28		Until 28 days from initiation of mechanical ventilation
Secondary	Duration of ventilation in survivors;	time between start invasive ventilation and successful extubation in survivors	Until 28 days from initiation of mechanical ventilation
Secondary	Use of prone positioning		Day 1 to Day 3 from initiation of mechanical ventilation
Secondary	Use of recruitment maneuvers		Day 1 to Day 3 from initiation of mechanical ventilation
Secondary	Incidence of acute kidney injury		Until 28 days from initiation of mechanical ventilation
Secondary	Duration of ICU stay	Time between admission and discharge ICU or death in ICU	Until 28 days from initiation of mechanical ventilation
Secondary	Duration of hospital stay	Time between admission and discharge from hospital or death in hospital	Until 28 days from initiation of mechanical ventilation
Secondary	ICU mortality	Any death during ICU stay	Until 28 days from initiation of mechanical ventilation
Secondary	Hospital mortality	Any death during hospital stay	Until 28 days from initiation of mechanical ventilation
Secondary	28-day mortality		Until 28 days from initiation of mechanical ventilation
Secondary	90-day mortality		Until 90 days from initiation of mechanical ventilation