In the last 10 years, severe acute respiratory infection (SARI) was responsible of multiple outbreaks putting a strain on the public health worldwide. Indeed, SARI had a relevant role in the development of pandemic and epidemic with terrible consequences such as the 2009 H1N1 pandemic which led to more than 200.000 respiratory deaths globally. In late December 2019, in Wuhan, Hubei, China, a new respiratory syndrome emerged with clinical signs of viral pneumonia and person-to-person transmission. Tests showed the appearance of a novel coronavirus, namely the 2019 novel coronavirus (COVID-19). Two other strains, the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) have caused severe respiratory illnesses, sometimes fatal. In particular, the mortality rate associated with SARS-CoV and MERS-CoV, was of 10% and 37% respectively. Even though COVID-19 appeared from the first time in China, quickly it spread worldwide and cases have been described in other countries such as Thailand, Japan, South Korea, Germany, Italy, France, Iran, USA and many other countries. An early paper reported 41 patients with laboratory-confirmed COVID-19 infection in Wuhan. The median age of the patients was 49 years and mostly men (73%). Among those, 32% were admitted to the ICU because of the severe hypoxemia. The most associated comorbidities were diabetes (20%), hypertension (15%), and cardiovascular diseases (15%). On admission, 98% of the patients had bilateral multiple lobular and sub-segmental areas of consolidation. Importantly, acute respiratory distress syndrome (ARDS) developed in 29% of the patients, while acute cardiac injury in 12%, and secondary infection in 10%. Invasive mechanical ventilation was required in 10% of those patients, and two of these patients (5%) had refractory hypoxemia and received extracorporeal membrane oxygenation (ECMO). In a later retrospective report by Wang and collaborators, clinical characteristics of 138 patients with COVID-19 infection were described. ICU admission was required in 26.1% of the patients for acute respiratory distress syndrome (61.1%), arrhythmia (44.4%), and shock (30.6%). ECMO support was needed in 11% of the patients admitted to the ICU. During the period of follow-up, overall mortality was 4.3%. The use of ECMO in COVID-19 infection is increasing due to the high transmission rate of the infection and the respiratory-related mortality. Therefore, the investigators believe that ECMO in case of severe interstitial pneumonia caused by COVID could represent a valid solution in order to avoid lung injuries related to prolonged treatment with non-invasive and invasive mechanical ventilation. In addition, ECMO could have a role for the systemic complications such as septic and cardiogenic shock as well myocarditis scenarios. Potential clinical effects and outcomes of the ECMO support in the novel coronavirus pandemic will be recorded and analyzed in our project. The researchers hypothesize that a significant percentage of patients with COVID-19 infection will require the utilize of ECMO for refactory hypoxemia, cardiogenic shock or septic shock. This study seeks to prove this hypothesis by conducting an observational retrospective/prospective study of patients in the ICU who underwent ECMO support and describe clinical features, severity of pulmonary dysfunction and risk factors of COVID-patients who need ECMO support, the incidence of ECMO use, ECMO technical characteristics, duration of ECMO, complications and outcomes of COVID-patients requiring ECMO support.
Study Type
OBSERVATIONAL
Enrollment
150
Universitätskliniken Innsbruck
Innsbruck, Austria
RECRUITINGLandesklinikum Sankt Polten
Sankt Pölten, Austria
RECRUITINGMedical University of Vienna
Vienna, Austria
RECRUITINGOnze Lieve Vrouwziekenhuis Aalst
Aalst, Belgium
Age
age in years
Time frame: at baseline
Gender
male/female
Time frame: at baseline
Weight
in kilograms
Time frame: at baseline
Height
in meters
Time frame: at baseline
BMI
weight and height combined to calculate BMI in kg/m\^2
Time frame: at baseline
Pre-existing pulmonary disease y/n
Asthma y/n, cystic fibrosis y/n, chronic obstructive pulmonary disease y/n, pulmonary hypertension y/n, pulmonary fibrosis y/n, chronic restrictive lung disease y/n
Time frame: at baseline
Main co-morbidities y/n
diabetes mellitus y/n, chronic renal failure y/n, ischemic heart disease y/n, heart failure y/n, chronic liver failure y/n, neurological impairment y/n
Time frame: at baseline
Date of signs of COVID-19 infection
in dd-mm-yyyy or mm-dd-yyyy
Time frame: at baseline or date of occurence
Date of positive swab
in dd-mm-yyyy or mm-dd-yyyy
Time frame: at baseline or date of occurence
Pre-ECMO length of hospital stay
in days
Time frame: at or during ECMO-implant
Pre-ECMO length of ICU stay
in days
Time frame: at or during ECMO-implant
Pre-ECMO length of mechanical ventilation days
in days
Time frame: at or during ECMO-implant
Use of antibiotics
y/n, what kind
Time frame: up to 6 months
Use of anti-viral treatment
y/n, what kind
Time frame: up to 6 months
Use of second line treatment
y/n, what kind (eg prone-position, recruitment manoeuvers, neuromuscular blockade etc)
Time frame: up to 6 months
Indications for ECMO-implant
respiratory or cardiac
Time frame: at ECMO-implant
Type of ECMO-implant
veno-venous, veno-arterial or veno-venoarterial
Time frame: at ECMO-implant
Type of access
peripheral or central
Time frame: at ECMO-implant
Date of ECMO implant
in dd-mm-yyyy or mm-dd-yyyy
Time frame: at ECMO-implant
ECMO blood flow rate
l/min
Time frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
ECMO gas flow rate
l/min
Time frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
ECMO configuration change
y/n
Time frame: up to 6 months
Date of ECMO configuration change
in dd-mm-yyyy or mm-dd-yyyy
Time frame: up to 6 months
New ECMO configuration
veno-venous, veno-arterial, veno-venoarterial, other
Time frame: up to 6 months
Indications for ECMO configuration change
right ventricular failure, left ventricular failure, refractory hypoxemia
Time frame: up to 6 months
Ventilator setting on ECMO
settings of ventilator
Time frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
Anticoagulation during ECMO
heparin, bivalirudin, nothing
Time frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
Frequency of ECMO circuit change
amount of ECMO circuit changes (1, 2, 3 etc.)
Time frame: up to 6 months
ECMO complications
Hemorrhagic, infection, other complications
Time frame: up to 6 months
ECMO Weaning
y/n
Time frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
ICU discharge
y/n, date
Time frame: from day of ICU-admission for every 24 hours until date of discharge or death, up to 6 months
Main cause of death
Time frame: 6 months
Type of discharge
Ward, another ICU, rehabilitation center, home
Time frame: up to 6 months
Alive/deceased
Time frame: 6 months
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University Hospital, Antwerp
Antwerp, Belgium
RECRUITINGCentre Hospitalier Universitaire Saint Pierre
Brussels, Belgium
RECRUITINGChirec
Brussels, Belgium
RECRUITINGErasme University Hospital
Brussels, Belgium
RECRUITINGUniversitair Ziekenhuis Brussel
Brussels, Belgium
RECRUITINGHôpital Civil Marie Curie de Charleroi
Charleroi, Belgium
RECRUITING...and 87 more locations