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Flow Controlled Ventilation in ARDS Associated With COVID-19

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ClinicalTrials.gov Identifier: NCT04399317
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation

Brief 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 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.


Condition or disease Intervention/treatment Phase
ARDS Associated With COVID-19 Device: Flow controlled ventilation (Evone-ventilator) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: randomization to treatment or control group
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Due to the technical facts (use of a different mechanical ventilator) only the participants (who are sedated) and the outcome assessor will be blinded for the treatment arm.
Primary Purpose: Treatment
Official Title: Flow Controlled Ventilation in ARDS Associated With COVID-19
Actual Study Start Date : May 28, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: Group A
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.
Device: Flow controlled ventilation (Evone-ventilator)
The new ventilation technique will be applied

No Intervention: Group B
These patients will be treated according to institutional standards. Only data will be collected. This is the control group.



Primary Outcome Measures :
  1. arterial oxygen partial pressure (PaO2) [ Time Frame: during 48 hours of treatment ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Refuse to sign the consent
  • Chronic Respiratory disease
  • Acute or chronic Cardiovascular disease
  • Pregnancy
  • Already under special therapy (prone position and/or ECMO)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04399317


Contacts
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Contact: Marcus Lance, MD, PhD +97433530292 ext +97433530292 mlance@hamad.qa
Contact: Nabil Shallik, MD +97433530292 ext +97433530292 Nshallik@hamad.qa

Locations
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Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar, 3050
Contact: Nabil Shallick, MD         
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
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Principal Investigator: Marcus Lance, MD, PhD Hamad Medical Corporation, Weill-Cornell-Medicine Qatar, Qatar University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT04399317    
Other Study ID Numbers: MRC-05-018
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: A decision regarding sharing information will be taken at later stage.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hamad Medical Corporation:
ARDS
COVID-19
Ventilation