COVIDPRoVENT-COVIDNCT04346342
PRactice of VENTilation in COVID-19 Patients (PRoVENT-COVID)
An observational study of COVID and Mechanical Ventilation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 22 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Mechanical Ventilation, Acute Respiratory Failure
- How many people
- 1,122 participants
- Where
- 22 sitesNetherlands
- Study dates
- 6 Mar 2020to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Invasively ventilated patients with COVID-19.
Who may be able to join
- 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
Who cannot join
- Age <18 years
- Already included in the same study in another hospital
- Having had received invasive ventilation > 24 hours in a non-participating hospital
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Netherlands22 sites
Flevoziekenhuis
Almere Stad
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam
Onze Lieve Vrouwe Gasthuis
Amsterdam
Gelre ziekenhuizen
Apeldoorn
Rijnstate Ziekenhuis
Arnhem
Amphia Ziekenhuis
Breda
Reinier de Graaf Gasthuis
Delft
Ziekenhuis Gelderse Vallei
Ede
Catharina Ziekenhuis
Eindhoven
Maxima Medical Center
Eindhoven
St Anna Ziekenhuis
Geldrop
Universitair Medisch Centrum Groningen
Groningen
Spaarne Gasthuis
Haarlem
Dijklander Ziekenhuis
Hoorn
Leeuwarden Medisch Centrum
Leeuwarden
Maastricht Universitair Medisch Centrum
Maastricht
St Antonius Ziekenhuis
Nieuwegein
Maasstad Hospital
Rotterdam
Zuyderland Medisch Centrum
Sittard
Haaglanden Medisch Centrum
The Hague
HagaZiekenhuis
The Hague
Isala Ziekenhuis
Zwolle
About this study
Official title: PRactice of VENTilation in COVID-19 Patients (PRoVENT-COVID) - an Observational Study of Invasively Ventilated Patients in the Netherlands
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.
Read the detailed 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.
- Conditions
- COVID, Mechanical Ventilation, Acute Respiratory Failure
- Keywords
- COVID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical ventilation | COVID patients receiving invasive mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation Mode
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Tidal volume set
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Expiratory tidal volume
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Positive end-expiratory pressure
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Maximum airway pressure or plateau pressure (P plateau) or peak pressure (P peak) (cm H2O);
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Level of pressure support above positive end-expiratory pressure (PEEP)
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Inspired fraction of oxygen
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Set and measured respiratory rate
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Inspiration to expiration ratio
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Secondary outcomes (11)
Number of ventilation-free days and alive at day 28
Measured: Until 28 days from initiation of mechanical ventilation
Duration of ventilation in survivors;
time between start invasive ventilation and successful extubation in survivors
Measured: Until 28 days from initiation of mechanical ventilation
Use of prone positioning
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Use of recruitment maneuvers
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Incidence of acute kidney injury
Measured: Until 28 days from initiation of mechanical ventilation
Duration of ICU stay
Time between admission and discharge ICU or death in ICU
Measured: Until 28 days from initiation of mechanical ventilation
Duration of hospital stay
Time between admission and discharge from hospital or death in hospital
Measured: Until 28 days from initiation of mechanical ventilation
ICU mortality
Any death during ICU stay
Measured: Until 28 days from initiation of mechanical ventilation
Hospital mortality
Any death during hospital stay
Measured: Until 28 days from initiation of mechanical ventilation
28-day mortality
Measured: Until 28 days from initiation of mechanical ventilation
90-day mortality
Measured: Until 90 days from initiation of mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start6 Mar 2020
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,122 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Marcus Schultz, MD, PhD, Principal investigator, Department of Intensive Care, Academic Medical Center, University of AmsterdamFrederique Paulus, PhD, Study chair, Department of Intensive Care, Academic Medical Center, University of AmsterdamAry Serpa Neto, MD, PhD, Study chair, Department of Intensive Care, Academic Medical Center, University of AmsterdamAnna Geke Algera, MD, Study director, Department of Intensive Care, Academic Medical Center, University of AmsterdamAnissa Tsonas, MD, Study director, Department of Intensive Care, Academic Medical Center, University of AmsterdamMichela Botta, MD, Study director, Department of Intensive Care, Academic Medical Center, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346342
- Sponsor's protocol ID
- PRoVENT-COVID
- Acronym
- PRoVENT-COVID
- Status last verified
- Jul 2021
- First submitted
- 9 Apr 2020
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahuja S, de Grooth HJ, Paulus F, van der Ven FL, Serpa Neto A, Schultz MJ, Tuinman PR; PRoVENT-COVID Study Collaborative Group* 'PRactice of VENTilation in COVID-19'. Association between early cumulative fluid balance and successful liberation from invasive ventilation in COVID-19 ARDS patients - insights from the PRoVENT-COVID study: a national, multicenter, observational cohort analysis. Crit Care. 2022 Jun 1;26(1):157. doi: 10.1186/s13054-022-04023-y.
PubMed 35650616Schuijt MTU, van Meenen DMP, Martin-Loeches I, Mazzinari G, Schultz MJ, Paulus F, Serpa Neto A. Association of Time-Varying Intensity of Ventilation With Mortality in Patients With COVID-19 ARDS: Secondary Analysis of the PRoVENT-COVID Study. Front Med (Lausanne). 2021 Nov 18;8:725265. doi: 10.3389/fmed.2021.725265. eCollection 2021.
PubMed 34869421Bos LDJ, Sjoding M, Sinha P, Bhavani SV, Lyons PG, Bewley AF, Botta M, Tsonas AM, Serpa Neto A, Schultz MJ, Dickson RP, Paulus F; PRoVENT-COVID collaborative group. Longitudinal respiratory subphenotypes in patients with COVID-19-related acute respiratory distress syndrome: results from three observational cohorts. Lancet Respir Med. 2021 Dec;9(12):1377-1386. doi: 10.1016/S2213-2600(21)00365-9. Epub 2021 Oct 13.
PubMed 34653374Schuijt MTU, Schultz MJ, Paulus F, Serpa Neto A; PRoVENT-COVID Collaborative Group. Association of intensity of ventilation with 28-day mortality in COVID-19 patients with acute respiratory failure: insights from the PRoVENT-COVID study. Crit Care. 2021 Aug 6;25(1):283. doi: 10.1186/s13054-021-03710-6.
PubMed 34362415Valk CMA, Tsonas AM, Botta M, Bos LDJ, Pillay J, Serpa Neto A, Schultz MJ, Paulus F; Writing Committee for the PRoVENT-COVID * Collaborative Group. Association of early positive end-expiratory pressure settings with ventilator-free days in patients with coronavirus disease 2019 acute respiratory distress syndrome: A secondary analysis of the Practice of VENTilation in COVID-19 study. Eur J Anaesthesiol. 2021 Dec 1;38(12):1274-1283. doi: 10.1097/EJA.0000000000001565.
PubMed 34238782Boers NS, Botta M, Tsonas AM, Algera AG, Pillay J, Dongelmans DA, Horn J, Vlaar APJ, Hollmann MW, Bos LDJ, Paulus F, Neto AS, Schultz MJ; PRoVENT-COVID investigatorsdagger. PRactice of VENTilation in Patients with Novel Coronavirus Disease (PRoVENT-COVID): rationale and protocol for a national multicenter observational study in The Netherlands. Ann Transl Med. 2020 Oct;8(19):1251. doi: 10.21037/atm-20-5107.
PubMed 33178783Botta M, Tsonas AM, Pillay J, Boers LS, Algera AG, Bos LDJ, Dongelmans DA, Hollmann MW, Horn J, Vlaar APJ, Schultz MJ, Neto AS, Paulus F; PRoVENT-COVID Collaborative Group. Ventilation management and clinical outcomes in invasively ventilated patients with COVID-19 (PRoVENT-COVID): a national, multicentre, observational cohort study. Lancet Respir Med. 2021 Feb;9(2):139-148. doi: 10.1016/S2213-2600(20)30459-8. Epub 2020 Oct 23.
PubMed 33169671
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRactice of VENTilation in COVID-19 Patients (PRoVENT-COVID) - an Observational Study of Invasively Ventilated Patients in the Netherlands
- ClinicalTrials.gov ID
- NCT04346342
- Acronym / sponsor ID
- PRoVENT-COVID / PRoVENT-COVID
- Conditions
- COVID, Mechanical Ventilation, Acute Respiratory Failure
- Keywords
- COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,122 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical ventilation | – | –COVID patients receiving invasive mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Invasively ventilated patients with COVID-19.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Age <18 years
- Already included in the same study in another hospital
- Having had received invasive ventilation > 24 hours in a non-participating hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ventilation Mode
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Tidal volume set
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Expiratory tidal volume
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Positive end-expiratory pressure
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Maximum airway pressure or plateau pressure (P plateau) or peak pressure (P peak) (cm H2O);
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Level of pressure support above positive end-expiratory pressure (PEEP)
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Inspired fraction of oxygen
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Set and measured respiratory rate
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Inspiration to expiration ratio
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
11 secondary outcomes
Number of ventilation-free days and alive at day 28
Time frame: Until 28 days from initiation of mechanical ventilation
Duration of ventilation in survivors;
Time frame: Until 28 days from initiation of mechanical ventilation
Use of prone positioning
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Use of recruitment maneuvers
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Incidence of acute kidney injury
Time frame: Until 28 days from initiation of mechanical ventilation
Duration of ICU stay
Time frame: Until 28 days from initiation of mechanical ventilation
Duration of hospital stay
Time frame: Until 28 days from initiation of mechanical ventilation
ICU mortality
Time frame: Until 28 days from initiation of mechanical ventilation
Hospital mortality
Time frame: Until 28 days from initiation of mechanical ventilation
28-day mortality
Time frame: Until 28 days from initiation of mechanical ventilation
90-day mortality
Time frame: Until 90 days from initiation of mechanical ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Derived from this study: PubMed 35650616Ahuja S, de Grooth HJ, Paulus F, van der Ven FL, Serpa Neto A, Schultz MJ, Tuinman PR; PRoVENT-COVID Study Collaborative Group* 'PRactice of VENTilation in COVID-19'. Association between early cumulative fluid balance and successful liberation from invasive ventilation in COVID-19 ARDS patients - insights from the PRoVENT-COVID study: a national, multicenter, observational cohort analysis. Crit Care. 2022 Jun 1;26(1):157. doi: 10.1186/s13054-022-04023-y.
- Derived from this study: PubMed 34869421Schuijt MTU, van Meenen DMP, Martin-Loeches I, Mazzinari G, Schultz MJ, Paulus F, Serpa Neto A. Association of Time-Varying Intensity of Ventilation With Mortality in Patients With COVID-19 ARDS: Secondary Analysis of the PRoVENT-COVID Study. Front Med (Lausanne). 2021 Nov 18;8:725265. doi: 10.3389/fmed.2021.725265. eCollection 2021.
- Derived from this study: PubMed 34653374Bos LDJ, Sjoding M, Sinha P, Bhavani SV, Lyons PG, Bewley AF, Botta M, Tsonas AM, Serpa Neto A, Schultz MJ, Dickson RP, Paulus F; PRoVENT-COVID collaborative group. Longitudinal respiratory subphenotypes in patients with COVID-19-related acute respiratory distress syndrome: results from three observational cohorts. Lancet Respir Med. 2021 Dec;9(12):1377-1386. doi: 10.1016/S2213-2600(21)00365-9. Epub 2021 Oct 13.
- Derived from this study: PubMed 34362415Schuijt MTU, Schultz MJ, Paulus F, Serpa Neto A; PRoVENT-COVID Collaborative Group. Association of intensity of ventilation with 28-day mortality in COVID-19 patients with acute respiratory failure: insights from the PRoVENT-COVID study. Crit Care. 2021 Aug 6;25(1):283. doi: 10.1186/s13054-021-03710-6.
- Derived from this study: PubMed 34238782Valk CMA, Tsonas AM, Botta M, Bos LDJ, Pillay J, Serpa Neto A, Schultz MJ, Paulus F; Writing Committee for the PRoVENT-COVID * Collaborative Group. Association of early positive end-expiratory pressure settings with ventilator-free days in patients with coronavirus disease 2019 acute respiratory distress syndrome: A secondary analysis of the Practice of VENTilation in COVID-19 study. Eur J Anaesthesiol. 2021 Dec 1;38(12):1274-1283. doi: 10.1097/EJA.0000000000001565.
- Derived from this study: PubMed 33178783Boers NS, Botta M, Tsonas AM, Algera AG, Pillay J, Dongelmans DA, Horn J, Vlaar APJ, Hollmann MW, Bos LDJ, Paulus F, Neto AS, Schultz MJ; PRoVENT-COVID investigatorsdagger. PRactice of VENTilation in Patients with Novel Coronavirus Disease (PRoVENT-COVID): rationale and protocol for a national multicenter observational study in The Netherlands. Ann Transl Med. 2020 Oct;8(19):1251. doi: 10.21037/atm-20-5107.
- Derived from this study: PubMed 33169671Botta M, Tsonas AM, Pillay J, Boers LS, Algera AG, Bos LDJ, Dongelmans DA, Hollmann MW, Horn J, Vlaar APJ, Schultz MJ, Neto AS, Paulus F; PRoVENT-COVID Collaborative Group. Ventilation management and clinical outcomes in invasively ventilated patients with COVID-19 (PRoVENT-COVID): a national, multicentre, observational cohort study. Lancet Respir Med. 2021 Feb;9(2):139-148. doi: 10.1016/S2213-2600(20)30459-8. Epub 2020 Oct 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Schultz, MD, PhD principal investigator
Department of Intensive Care, Academic Medical Center, University of Amsterdam
Frederique Paulus, PhD study chair
Department of Intensive Care, Academic Medical Center, University of Amsterdam
Ary Serpa Neto, MD, PhD study chair
Department of Intensive Care, Academic Medical Center, University of Amsterdam
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Mechanical Ventilation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 22 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation Mode (time frame: Day 1 to Day 3 from initiation of mechanical ventilation). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04346342, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.