ARDS Associated With COVID-19NCT04399317
Flow Controlled Ventilation in ARDS Associated With COVID-19
A study of ARDS Associated With COVID-19, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
The pandemic of a newly upcoming viral disease which is associated with COVID-19 puts the whole world's health system under pressure. Patients suffering from this disease mainly develop respiratory symptoms, which can lead to severe acute respiratory distress syndrome (ARDS) necessitating ICU, admission in 10-20% of… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- ARDS Associated With COVID-19
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteQatar
- Study dates
- 28 May 2020to Aug 2020
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients with ARDS due to COVID-19
- need for mechanical ventilation
- P/F ratio <200mmHg
- PEEP of at least >5cmH2O
- BMI less 30 kg/ m2
Who cannot join
- Refuse to sign the consent
- Chronic Respiratory disease
- Acute or chronic Cardiovascular disease
- Pregnancy
- Already under special therapy (prone position and/or ECMO)
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Corporation
Doha, 3050
Nabil Shallick, MD
About this study
The pandemic of a newly upcoming viral disease which is associated with COVID-19 puts the whole world's health system under pressure.
Patients suffering from this disease mainly develop respiratory symptoms, which can lead to severe acute respiratory distress syndrome (ARDS) necessitating ICU, admission in 10-20% of the cases admitted to hospital. In addition to these symptoms, patients show lymphopenia, cardiac symptoms and altered coagulation profiles. Although those patients are treated in the ICU the mortality is up to 20% due to multiorgan failure. The aim of this study is to show non-inferiority of flow-controlled ventilation compared to standard (lung protective ventilation).
Read more
Methods:
After admission to the ICU, the patients will receive information about the study and informed consent will be taken. Upon reaching the criteria for moderate to severe ARDS (P/F ratio below 200 mmHg and PEEP above 5 cmH2O) the patients will be randomized. In the treatment group (group A) the ultra-thin ventilation tube will be placed through the existing tube. Then flow-controlled ventilation will be applied for 48 hours. In the other group (group B) ventilation will be performed according to the lung protective strategy. All other treatment will be unchanged.
Data-collection will be started 1 hour after initiation of the study. Primary end point is PaO2.
Read the detailed description
The pandemic of a newly upcoming viral disease which is associated with COVID-19 puts the whole world's health system under pressure.
Patients suffering from this disease mainly develop respiratory symptoms, which can lead to severe acute respiratory distress syndrome (ARDS) necessitating ICU admission in 10-20% of the cases admitted to hospital. In addition to these symptoms, patients show lymphopenia, cardiac symptoms and altered coagulation profiles. Although those patients are treated in the ICU the mortality there is up to 20% due to multiorgan failure. Currently, there is no proven therapeutic strategy next to symptomatic treatment.
Although the severely ill patients will need intubation and invasive ventilation according to ARDS treatment strategies including low tidal volumes and low end-expiratory pressures, not all patients recover their pulmonary function.
Flow control ventilation (FCV) is a recently developed ventilation strategy which allows to keep the intrapulmonary pressures low while achieving optimal gas exchange. It had been proven in animal models to improve pulmonary function and oxygenation and in cases with ARDS.
Flow Controlled Ventilation mode is a unique ventilation technique in which inspiration as well as expiration are controlled i.e. actively performed. This is achieved by generating a continuous flow into the patient's lungs during inspiration or a continuous (negative) flow, sucking gasses out of the patient's lungs.
The continuous flow without ventilation pauses, results in linear increases and decreases in intratracheal pressures. As a result, the mean airway pressure will be higher compared to conventional large bore Volume Controlled Ventilation or Pressure Controlled Ventilation (PCV). Therefore, the bronchiole and alveoli will be kept open during ventilation facilitating oxygen uptake to the blood. Moreover, the continuous gas flow enhances gas mixture in the lungs also improving gas exchange. Altogether, FCV results in more efficient ventilation as compared to conventional ventilation techniques.
Evone® is the only commercially available ventilator applying FCV ventilation mode, thus directing the inspiration as well as the expiration. Evone's FCV® ventilation mode is based on a controlled inspiration and expiration flow from a set PEEP to a set peak pressure and vice versa. The inspiratory flow is continuously controlled by advanced mass flow regulators; the expiratory flow is controlled by regulated suctioning.
Aim of the study This study aims to demonstrate the positive effects on oxygenation of flow-controlled ventilation compared to conventionally ventilated patients (pressure control ventilation) in patients suffering from ARDS associated with COVID-19.
- Conditions
- ARDS Associated With COVID-19
- Being tested
- Flow controlled ventilation (Evone-ventilator)
- Keywords
- ARDS, COVID-19, Ventilation
- Medical subject headings
- COVID-19, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow controlled ventilation (Evone-ventilator)Device
The new ventilation technique will be applied
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | This is the treatment group. Patients will be ventilated using the new device (Evone) applying flow controlled ventilation for 48 hours. Ventilation parameters will be assessed every 6-8 hours. All other treatment will be unchanged and according to institutional standards. Receives: Device: Flow controlled ventilation (Evone-ventilator) |
| Group B | No intervention | These patients will be treated according to institutional standards. Only data will be collected. This is the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial oxygen partial pressure (PaO2)
Measured: during 48 hours of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start28 May 2020
- Primary completionJul 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARDS Associated With COVID-19Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- randomization to treatment or control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcus Lance, MD, PhD, Principal investigator, Hamad Medical Corporation, Weill-Cornell-Medicine Qatar, Qatar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399317
- Sponsor's protocol ID
- MRC-05-018
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding sharing information will be taken at later stage.
Publications
Roehrig S, Ait Hssain A, Shallik NAH, Elsaid IMA, Mustafa SF, Smain OAM, Molokhia AA, Lance MD. Flow controlled ventilation in Acute Respiratory Distress Syndrome associated with COVID-19: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Sep 11;21(1):781. doi: 10.1186/s13063-020-04708-1.
PubMed 32917259
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Controlled Ventilation in ARDS Associated With COVID-19
- ClinicalTrials.gov ID
- NCT04399317
- Acronym / sponsor ID
- MRC-05-018
- Conditions
- ARDS Associated With COVID-19
- Keywords
- ARDS, COVID-19, Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 May 2020 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 22 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 pandemic of a newly upcoming viral disease which is associated with COVID-19 puts the whole world's health system under pressure.
Patients suffering from this disease mainly develop respiratory symptoms, which can lead to severe acute respiratory distress syndrome (ARDS) necessitating ICU, admission in 10-20% of the cases admitted to hospital. In addition to these symptoms, patients show lymphopenia, cardiac symptoms and altered coagulation profiles. Although those patients are treated in the ICU the mortality is up to 20% due to multiorgan failure. The aim of this study is to show non-inferiority of flow-controlled ventilation compared to standard (lung protective ventilation).
Methods:
After admission to the ICU, the patients will receive information about the study and informed consent will be taken. Upon reaching the criteria for moderate to severe ARDS (P/F ratio below 200 mmHg and PEEP above 5 cmH2O) the patients will be randomized. In the treatment group (group A) the ultra-thin ventilation tube will be placed through the existing tube. Then flow-controlled ventilation will be applied for 48 hours. In the other group (group B) ventilation will be performed according to the lung protective strategy. All other treatment will be unchanged.
Data-collection will be started 1 hour after initiation of the study. Primary end point is PaO2.
Detailed description
The pandemic of a newly upcoming viral disease which is associated with COVID-19 puts the whole world's health system under pressure.
Patients suffering from this disease mainly develop respiratory symptoms, which can lead to severe acute respiratory distress syndrome (ARDS) necessitating ICU admission in 10-20% of the cases admitted to hospital. In addition to these symptoms, patients show lymphopenia, cardiac symptoms and altered coagulation profiles. Although those patients are treated in the ICU the mortality there is up to 20% due to multiorgan failure. Currently, there is no proven therapeutic strategy next to symptomatic treatment.
Although the severely ill patients will need intubation and invasive ventilation according to ARDS treatment strategies including low tidal volumes and low end-expiratory pressures, not all patients recover their pulmonary function.
Flow control ventilation (FCV) is a recently developed ventilation strategy which allows to keep the intrapulmonary pressures low while achieving optimal gas exchange. It had been proven in animal models to improve pulmonary function and oxygenation and in cases with ARDS.
Flow Controlled Ventilation mode is a unique ventilation technique in which inspiration as well as expiration are controlled i.e. actively performed. This is achieved by generating a continuous flow into the patient's lungs during inspiration or a continuous (negative) flow, sucking gasses out of the patient's lungs.
The continuous flow without ventilation pauses, results in linear increases and decreases in intratracheal pressures. As a result, the mean airway pressure will be higher compared to conventional large bore Volume Controlled Ventilation or Pressure Controlled Ventilation (PCV). Therefore, the bronchiole and alveoli will be kept open during ventilation facilitating oxygen uptake to the blood. Moreover, the continuous gas flow enhances gas mixture in the lungs also improving gas exchange. Altogether, FCV results in more efficient ventilation as compared to conventional ventilation techniques.
Evone® is the only commercially available ventilator applying FCV ventilation mode, thus directing the inspiration as well as the expiration. Evone's FCV® ventilation mode is based on a controlled inspiration and expiration flow from a set PEEP to a set peak pressure and vice versa. The inspiratory flow is continuously controlled by advanced mass flow regulators; the expiratory flow is controlled by regulated suctioning.
Aim of the study This study aims to demonstrate the positive effects on oxygenation of flow-controlled ventilation compared to conventionally ventilated patients (pressure control ventilation) in patients suffering from ARDS associated with COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomization to treatment or control group
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Flow controlled ventilation (Evone-ventilator)This is the treatment group. Patients will be ventilated using the new device (Evone) applying flow controlled ventilation for 48 hours. Ventilation parameters will be assessed every 6-8 hours. All other treatment will be unchanged and according to institutional standards. |
| Group B | No intervention | –These patients will be treated according to institutional standards. Only data will be collected. This is the control group. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients with ARDS due to COVID-19
- need for mechanical ventilation
- P/F ratio <200mmHg
- PEEP of at least >5cmH2O
- BMI less 30 kg/ m2
Key exclusion criteria (5 listed)
- Refuse to sign the consent
- Chronic Respiratory disease
- Acute or chronic Cardiovascular disease
- Pregnancy
- Already under special therapy (prone position and/or ECMO)
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 |
|---|---|---|
| Flow controlled ventilation (Evone-ventilator)The new ventilation technique will be applied | Device | Group A |
Primary outcome
arterial oxygen partial pressure (PaO2)
Time frame: during 48 hours of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Derived from this study: PubMed 32917259Roehrig S, Ait Hssain A, Shallik NAH, Elsaid IMA, Mustafa SF, Smain OAM, Molokhia AA, Lance MD. Flow controlled ventilation in Acute Respiratory Distress Syndrome associated with COVID-19: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Sep 11;21(1):781. doi: 10.1186/s13063-020-04708-1.
- Individual participant dataSharing planned: Undecided. A decision regarding sharing information will be taken at later stage.
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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 Lance, MD, PhD principal investigator
Hamad Medical Corporation, Weill-Cornell-Medicine Qatar, Qatar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of ARDS Associated With COVID-19, run by Hamad Medical Corporation at 1 site in Qatar.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Jun 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 Qatar. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcus Lance, MD, PhD (+97433530292 ext. +97433530292, mlance@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial oxygen partial pressure (PaO2) (time frame: during 48 hours of treatment). 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 NCT04399317, which also lists 1 linked publication.
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 25 Jun 2020.