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Flow Controlled Ventilation in ARDS Associated With COVID-19

NCT04399317 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-06-25

No results posted yet for this study

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.

Conditions

  • ARDS Associated With COVID-19

Interventions

DEVICE

Flow controlled ventilation (Evone-ventilator)

The new ventilation technique will be applied

Sponsors & Collaborators

  • Hamad Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Marcus Lance, MD, PhD · Hamad Medical Corporation, Weill-Cornell-Medicine Qatar, Qatar University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-28
Primary Completion
2020-07-31
Completion
2020-08-31

Countries

  • Qatar

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04399317 on ClinicalTrials.gov