Flow Controlled Ventilation in ARDS Associated With COVID-19

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.

Study Overview

• Status: Unknown
• Conditions: ARDS Associated With COVID-19
• Intervention / Treatment: Device: Flow controlled ventilation (Evone-ventilator)

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: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Qatar
  • Doha, Qatar, 3050
    • Recruiting
    • Hamad Medical Corporation
    • Contact: Nabil Shallick, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
arterial oxygen partial pressure (PaO2)	during 48 hours of treatment

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation
• Investigators: Principal Investigator: Marcus Lance, MD, PhD, Hamad Medical Corporation, Weill-Cornell-Medicine Qatar, Qatar University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2020
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; ARDS; Ventilation
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: MRC-05-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: A decision regarding sharing information will be taken at later stage.

Drug and device information, study documents

• 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