Predictors of Non-invasive Respiratory Support Failure in COVID-19 Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Failure of Non Invasive Ventilation
研究概览
简要总结
The main objective of the current study is to search predictors of non-invasive respiratory support failure, like high -flow oxygen system (HFO) and pressure systems, Bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP), in patients with acute hypoxemia produced by COVID-19 pneumonia.
In the first phase, we will do a retrospective review of the intermediate respiratory care unit activity from March to May 2020 in the target population. In the second phase development an interventional study. At admission all patients will be treated with HFS monitoring clinical variables like respiratory frequency, oxygen saturation, gasometer results and oxygen inspiration fraction. In case of HFO failure, the patients will be randomized to treatment with CPAP or BIPAP. The same clinical variables will be monitoring to analysis their prediction capacity of failure therapy, defined as mortality or need to intubation. The results will be adjusted comorbidity grade, age and initial severity pneumonia. Secondary objectives of study are 90 days mortality, functional recovery at 90 days and to realise a cost-effectiveness valuation of non-invasive respiratory supports in this disease.
详细描述
The purpose of the study
Pneumonia caused by the SARS Cov-2 coronavirus is a viral infectious disease that is characterized in some cases by the rapid and progressive respiratory failure of the respiratory system, being the most serious affectation and the one that marks the prognosis. Non-invasive breathing supports are therapies that help you breathe in severe respiratory failure. Therefore, monitoring of respiratory exhaustion should be carried out in all patients with SARS Cov-2 pneumonia. Within this follow-up, prognostic factors could be identified that help to assess with what probability the treatment with these supports may or may not be successful.
We will carry out a prospective, descriptive study at this center in order to assess respiratory clinical variables by telemetry recording and blood tests during follow-up.
To do this, we will carry out, during the follow-up of patients already diagnosed, or with a new diagnosis of SARS Cov-2 pneumonia and respiratory failure, who require non-invasive support therapy, an analysis on the first day of initiation of therapy, at 48 hours and at the end of this therapy, we will also continuously monitor vital signs while these therapies are used. We will compare the values obtained from patients who only require therapy with high-flow nasal cannulas and from patients who are not sufficient for this treatment and need non-invasive mechanical ventilation.
Participants in this study who do not have sufficient respiratory support with high-flow cannula therapy and feel exhausted, will be switched to non-invasive mechanical ventilation. Each patient will be randomly assigned to one of two possible settings: setting A (continuous pressure mechanical ventilation) or setting B (intermittent pressure mechanical ventilation). This decision is made because to date there are no scientifically proven differences in which configuration is best for the treatment of this disease. The data on the success of the therapies will be compared, understanding as failure the need for orotracheal intubation to perform invasive mechanical ventilation or death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Severe hypoxemic respiratory failure (partial pressure of arterial oxygen/ fraction of inspired oxygen < 250 mmHg).
- •Confirmed SARS-Cov2 infection.
- •Radiological images compatible with pneumonia covid.
排除标准
- •Hypoxemic respiratory failure secondary to a cause other than SARS-Cov2 pneumonia.
- •Hypercapnic respiratory failure.
- •Patient with criteria of orotracheal intubation at admission.
- •Glasgow < 15
- •Haemodynamic instability that needs drugs treatment
- •Patients with swallowing problems that conditioned an aspiration pneumonia risk.
结局指标
主要结局
Failure of Non Invasive Ventilation
时间窗: From the start of CPAP or BIPAP to intubation and invasive ventilation or death at 30 days
The number of patients with respiratory work or desaturation and who need orotracheal intubation or die will be measured. This will be defined with desaturation below 90%, respiratory rate above 30 o pO2 below 60 despite receiving a maximum pressure support and with 100% FIO2.
Failure of High Flow Nasal Cannula
时间窗: From the start of High Flow Nasal Cannula support to intubation and invasive ventilation or death at 30 days.
The number of patients with respiratory work or desaturation at the beginning of therapy with high-flow nasal cannulas will be measured. This will be defined with desaturation below 90%, respiratory rate greater than 30 o pO2 below 60 despite receiving a maximum support of 60 liters per minute and with 100% FIO2.
次要结局
- 90-day at home recovery(From the inclusion to 90 days after inclusion in the study.)
研究者
Irene Aldas
Principal Investigator, Respiratory Intermediate Care Unit.
Germans Trias i Pujol Hospital