European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID Patients in ECMO
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 97
- 主要终点
- Type of access
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Laboratory-confirmed COVID-19 infection by real-time PCR (polymerase chain reaction)
- •ECMO for treatment severe lung disease COVID-19 related
排除标准
- •Patients treated with ECMO for other concomitant causes.
结局指标
主要结局
Type of access
时间窗: at ECMO-implant
peripheral or central
ECMO configuration change
时间窗: up to 6 months
y/n
Date of signs of COVID-19 infection
时间窗: at baseline or date of occurence
in dd-mm-yyyy or mm-dd-yyyy
Weight
时间窗: at baseline
in kilograms
BMI
时间窗: at baseline
weight and height combined to calculate BMI in kg/m\^2
Date of positive swab
时间窗: at baseline or date of occurence
in dd-mm-yyyy or mm-dd-yyyy
Date of ECMO configuration change
时间窗: up to 6 months
in dd-mm-yyyy or mm-dd-yyyy
Anticoagulation during ECMO
时间窗: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
heparin, bivalirudin, nothing
Frequency of ECMO circuit change
时间窗: up to 6 months
amount of ECMO circuit changes (1, 2, 3 etc.)
Main co-morbidities y/n
时间窗: at baseline
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
Pre-ECMO length of mechanical ventilation days
时间窗: at or during ECMO-implant
in days
Use of second line treatment
时间窗: up to 6 months
y/n, what kind (eg prone-position, recruitment manoeuvers, neuromuscular blockade etc)
Indications for ECMO-implant
时间窗: at ECMO-implant
respiratory or cardiac
ECMO blood flow rate
时间窗: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
l/min
ICU discharge
时间窗: from day of ICU-admission for every 24 hours until date of discharge or death, up to 6 months
y/n, date
Age
时间窗: at baseline
age in years
Gender
时间窗: at baseline
male/female
Height
时间窗: at baseline
in meters
Pre-existing pulmonary disease y/n
时间窗: at baseline
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
Pre-ECMO length of ICU stay
时间窗: at or during ECMO-implant
in days
Date of ECMO implant
时间窗: at ECMO-implant
in dd-mm-yyyy or mm-dd-yyyy
Ventilator setting on ECMO
时间窗: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
settings of ventilator
Alive/deceased
时间窗: 6 months
Use of antibiotics
时间窗: up to 6 months
y/n, what kind
Pre-ECMO length of hospital stay
时间窗: at or during ECMO-implant
in days
Type of ECMO-implant
时间窗: at ECMO-implant
veno-venous, veno-arterial or veno-venoarterial
Use of anti-viral treatment
时间窗: up to 6 months
y/n, what kind
Main cause of death
时间窗: 6 months
ECMO gas flow rate
时间窗: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
l/min
New ECMO configuration
时间窗: up to 6 months
veno-venous, veno-arterial, veno-venoarterial, other
Indications for ECMO configuration change
时间窗: up to 6 months
right ventricular failure, left ventricular failure, refractory hypoxemia
ECMO complications
时间窗: up to 6 months
Hemorrhagic, infection, other complications
ECMO Weaning
时间窗: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
y/n
Type of discharge
时间窗: up to 6 months
Ward, another ICU, rehabilitation center, home
次要结局
未报告次要终点
