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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

Tracking Information
First Submitted Date  ICMJE May 18, 2020
First Posted Date  ICMJE May 22, 2020
Last Update Posted Date June 25, 2020
Actual Study Start Date  ICMJE May 28, 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2020)
arterial oxygen partial pressure (PaO2) [ Time Frame: during 48 hours of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Flow Controlled Ventilation in ARDS Associated With COVID-19
Official Title  ICMJE Flow Controlled Ventilation in ARDS Associated With COVID-19
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE ARDS Associated With COVID-19
Intervention  ICMJE Device: Flow controlled ventilation (Evone-ventilator)
The new ventilation technique will be applied
Study Arms  ICMJE
  • 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.
    Intervention: Device: Flow controlled ventilation (Evone-ventilator)
  • No Intervention: Group B
    These patients will be treated according to institutional standards. Only data will be collected. This is the control group.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marcus Lance, MD, PhD +97433530292 ext +97433530292 mlance@hamad.qa
Contact: Nabil Shallik, MD +97433530292 ext +97433530292 Nshallik@hamad.qa
Listed Location Countries  ICMJE Qatar
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04399317
Other Study ID Numbers  ICMJE MRC-05-018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: A decision regarding sharing information will be taken at later stage.
Responsible Party Hamad Medical Corporation
Study Sponsor  ICMJE Hamad Medical Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marcus Lance, MD, PhD Hamad Medical Corporation, Weill-Cornell-Medicine Qatar, Qatar University
PRS Account Hamad Medical Corporation
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP