ARDSAPRV-COVID19NCT04386369
Evaluation of Airway Pressure Release Ventilation in COVID-19 ARDS
An observational study of ARDS and COVID19, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The 2020 pandemic of the coronavirus (SARS-CoV2) has lead to an increase in ARDS cases requiring invasive mechanical ventilation in the ICU (Intensive Care Unit). The investigators hypothesize that airway pressure release ventilation (APRV) could be beneficial in patients with ARDS secondary to SARS-COV2 viral… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Airway pressure release ventilation
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2020to 1 Jun 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: Adult patients admitted to the Intensive Care Unit for treatment of COVID-19 related acute respiratory failure.
Who may be able to join
- Patients treated in Nancy University Hospital between 01/04/2020 and 31/06/2020 for COVID-19 ARDS, requiring invasive ventilation
- Trial of airway pressure release ventilation during the ICU stay
Who cannot join
- Patients requiring veno-venous ECMO
- Patients unable to complete the 6-hour APRV trial due to poor tolerance : SpO2 decrease < 90% on FiO2 70%, haemodynamic instability (MAP < 65mmhg without vasopressors, or 0.5 mg/h increase in norepinephrine, ventilator asynchrony (respiratory rate >35), hypercapnia (pH < 7,25 or PaCO2 >60mmHg)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Airway Pressure Release Ventilation on Oxygenation in Acute Respiratory Distress Syndrome in Adult Patients With COVID-19 Pneumonia
The 2020 pandemic of the coronavirus (SARS-CoV2) has lead to an increase in ARDS cases requiring invasive mechanical ventilation in the ICU (Intensive Care Unit).
The investigators hypothesize that airway pressure release ventilation (APRV) could be beneficial in patients with ARDS secondary to SARS-COV2 viral pneumonia.
Read the detailed description
Lung protective mechanical ventilation is the cornerstone of ARDS management, reducing the work of respiratory muscles and optimizing gas exchange. However, it can be the source of deleterious effects, grouped under the terms of ventilator induced lung injury (VILI) and ventilator induced diaphragm dysfunction.
The protective ventilatory strategy has led to a significant improvement in the prognosis of ARDS patients, by reducing the volume of the air and oxygen mixture (lower tidal volume) delivered to the lungs and thus reducing the pulmonary stress and strain. However, this protective ventilation usually requires deep sedation and neuromuscular blockade to avoid deleterious patient-ventilator asynchrony.
Airway Pressure Release Ventilation (APRV) has been proposed to reduce patient-ventilator asynchrony and reduce the VILI. The operating principles of APRV are based on the presence of two pressure levels that are kept constant. Spontaneous breathing is possible at any time at both pressure levels if the patient is not deeply sedated or under neuromuscular blockade.
The investigators hypothesize that APRV mode could be beneficial on oxygenation and respiratory work in patients with ARDS secondary to SARS-COV2 viral pneumonia.
- Being tested
- Airway pressure release ventilation
- Keywords
- Airway Pressure Release Ventilation, Intensive Care Unit, SARS-CoV-2, APRV, Acute respiratory failure
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway pressure release ventilationOther
Ventilator management strategy
| Study group | Role | What they receive |
|---|---|---|
| Airway Pressure Release Ventilation | Patients with COVID-19 ARDS requiring invasive mechanical ventilation in ICU, on Volume Assist Control ventilation (VAC) or Pressure Assist Control (PAC), are switched to airway pressure ventilation (APRV). If APRV doesn't lead to improvement in oxygenation the ventilatory mode is switched back to VAC or PAC ventilatory mode. Receives: Other: Airway pressure release ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients improving PaO2/FiO2 ratio at 6 hours of APRV
Increase of at least 20% of the PaO2/FiO2 ratio
Measured: 6 hours after starting APRV
Secondary outcomes (8)
Number of interventions on ventilator settings
Number of interventions by the physician on APRV settings
Measured: 6 hours after starting APRV
Change in mean blood pressure
Variations of blood pressure in millimeters of mercury
Measured: 6 hours after starting APRV
Change in heart rate
Variations of heart rate in beats per minute
Measured: 6 hours after starting APRV
Changes in catecholamine doses
Variations of catecholamine doses in milligrams per hours
Measured: 6 hours after starting APRV
Changes in static compliance at the end of 6 hours of APRV
Static compliance (Cstat) defined as : Cstat = (VT/(Pplat-PEPtot)) Tidal Volume (VT), Plateau pressure (Pplat) and Total Positive End-expiratory Pressure (PEEPtot)
Measured: 6 hours after starting APRV
Variations of minute ventilation
Minute ventilation in liters per minute
Measured: 6 hours after starting APRV
Changes in static compliance 4 hours after stopping APRV
Static compliance (Cstat) defined as : Cstat = (VT/(Pplat-PEPtot)) Tidal Volume (VT), Plateau pressure (Pplat) and Total Positive End-expiratory Pressure (PEEPtot)
Measured: 4 hours after starting APRV
Proportion of patients with a decrease of the PaO2/FiO2 ratio
Percentage of patients with a decrease of the PaO2/FiO2 ratio
Measured: 4 hours after stopping APRV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start15 Apr 2020
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Koszutski, MD, Principal investigator, CHRU de NANCY, Médecine Intensive et Réanimation Brabois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386369
- Sponsor's protocol ID
- 2020PI076
- Acronym
- APRV-COVID19
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou Y, Jin X, Lv Y, Wang P, Yang Y, Liang G, Wang B, Kang Y. Early application of airway pressure release ventilation may reduce the duration of mechanical ventilation in acute respiratory distress syndrome. Intensive Care Med. 2017 Nov;43(11):1648-1659. doi: 10.1007/s00134-017-4912-z. Epub 2017 Sep 22.
PubMed 28936695Nieman GF, Al-Khalisy H, Kollisch-Singule M, Satalin J, Blair S, Trikha G, Andrews P, Madden M, Gatto LA, Habashi NM. A Physiologically Informed Strategy to Effectively Open, Stabilize, and Protect the Acutely Injured Lung. Front Physiol. 2020 Mar 19;11:227. doi: 10.3389/fphys.2020.00227. eCollection 2020.
PubMed 32265734
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Airway Pressure Release Ventilation on Oxygenation in Acute Respiratory Distress Syndrome in Adult Patients With COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04386369
- Acronym / sponsor ID
- APRV-COVID19 / 2020PI076
- Keywords
- Airway Pressure Release Ventilation, Intensive Care Unit, SARS-CoV-2, APRV, Acute respiratory failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 13 May 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 2020 pandemic of the coronavirus (SARS-CoV2) has lead to an increase in ARDS cases requiring invasive mechanical ventilation in the ICU (Intensive Care Unit).
The investigators hypothesize that airway pressure release ventilation (APRV) could be beneficial in patients with ARDS secondary to SARS-COV2 viral pneumonia.
Detailed description
Lung protective mechanical ventilation is the cornerstone of ARDS management, reducing the work of respiratory muscles and optimizing gas exchange. However, it can be the source of deleterious effects, grouped under the terms of ventilator induced lung injury (VILI) and ventilator induced diaphragm dysfunction.
The protective ventilatory strategy has led to a significant improvement in the prognosis of ARDS patients, by reducing the volume of the air and oxygen mixture (lower tidal volume) delivered to the lungs and thus reducing the pulmonary stress and strain. However, this protective ventilation usually requires deep sedation and neuromuscular blockade to avoid deleterious patient-ventilator asynchrony.
Airway Pressure Release Ventilation (APRV) has been proposed to reduce patient-ventilator asynchrony and reduce the VILI. The operating principles of APRV are based on the presence of two pressure levels that are kept constant. Spontaneous breathing is possible at any time at both pressure levels if the patient is not deeply sedated or under neuromuscular blockade.
The investigators hypothesize that APRV mode could be beneficial on oxygenation and respiratory work in patients with ARDS secondary to SARS-COV2 viral pneumonia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Airway Pressure Release Ventilation | – | Other: Airway pressure release ventilationPatients with COVID-19 ARDS requiring invasive mechanical ventilation in ICU, on Volume Assist Control ventilation (VAC) or Pressure Assist Control (PAC), are switched to airway pressure ventilation (APRV). If APRV doesn't lead to improvement in oxygenation the ventilatory mode is switched back to VAC or PAC ventilatory mode. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the Intensive Care Unit for treatment of COVID-19 related acute respiratory failure.
Key inclusion criteria (2 listed)
- Patients treated in Nancy University Hospital between 01/04/2020 and 31/06/2020 for COVID-19 ARDS, requiring invasive ventilation
- Trial of airway pressure release ventilation during the ICU stay
Key exclusion criteria (2 listed)
- Patients requiring veno-venous ECMO
- Patients unable to complete the 6-hour APRV trial due to poor tolerance : SpO2 decrease < 90% on FiO2 70%, haemodynamic instability (MAP < 65mmhg without vasopressors, or 0.5 mg/h increase in norepinephrine, ventilator asynchrony (respiratory rate >35), hypercapnia (pH < 7,25 or PaCO2 >60mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airway pressure release ventilationVentilator management strategy | Other | Airway Pressure Release Ventilation |
Primary outcome
Proportion of patients improving PaO2/FiO2 ratio at 6 hours of APRV
Time frame: 6 hours after starting APRV
Increase of at least 20% of the PaO2/FiO2 ratio
8 secondary outcomes
Number of interventions on ventilator settings
Time frame: 6 hours after starting APRV
Change in mean blood pressure
Time frame: 6 hours after starting APRV
Change in heart rate
Time frame: 6 hours after starting APRV
Changes in catecholamine doses
Time frame: 6 hours after starting APRV
Changes in static compliance at the end of 6 hours of APRV
Time frame: 6 hours after starting APRV
Variations of minute ventilation
Time frame: 6 hours after starting APRV
Changes in static compliance 4 hours after stopping APRV
Time frame: 4 hours after starting APRV
Proportion of patients with a decrease of the PaO2/FiO2 ratio
Time frame: 4 hours after stopping APRV
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 14 Sep 2020.
- Background: PubMed 28936695Zhou Y, Jin X, Lv Y, Wang P, Yang Y, Liang G, Wang B, Kang Y. Early application of airway pressure release ventilation may reduce the duration of mechanical ventilation in acute respiratory distress syndrome. Intensive Care Med. 2017 Nov;43(11):1648-1659. doi: 10.1007/s00134-017-4912-z. Epub 2017 Sep 22.
- Background: PubMed 32265734Nieman GF, Al-Khalisy H, Kollisch-Singule M, Satalin J, Blair S, Trikha G, Andrews P, Madden M, Gatto LA, Habashi NM. A Physiologically Informed Strategy to Effectively Open, Stabilize, and Protect the Acutely Injured Lung. Front Physiol. 2020 Mar 19;11:227. doi: 10.3389/fphys.2020.00227. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Matthieu Koszutski, MD principal investigator
CHRU de NANCY, Médecine Intensive et Réanimation Brabois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS and COVID19, run by Central Hospital, Nancy, France at 1 site in France.
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 2 inclusion and 2 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 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Proportion of patients improving PaO2/FiO2 ratio at 6 hours of APRV (time frame: 6 hours after starting APRV). 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 NCT04386369, which also lists 2 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 14 Sep 2020.