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临床试验/NCT04407260
NCT04407260已完成不适用

The Use of Oxygen Hoods in Patients Failing on Conventional High-flow Oxygen Delivery Systems, the Effects on Oxygenation, Mechanical Ventilation and Mortality Rates in Hypoxic Patients With COVID-19. A Prospective Controlled Cohort Study.

Northwell Health1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2020年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
136
试验地点
1
主要终点
Oxygen saturation

研究概览

简要总结

To determine whether the use of oxygen hoods as compared to conventional high-flow oxygen delivery systems, and the effects on oxygenation, mechanical ventilation and mortality rates in hypoxic patients with COVID-19.

详细描述

To determine whether Oxygen hoods improve O2-saturation (SaO2), and how they effect length of hospitalization, and in-hospital mechanical ventilation and mortality rates in Covid-19 patients when compared to conventional high-flow oxygen delivery systems. Oxy-hemoglobin saturation is continuously measured by pulse-oximetry including immediately before and after oxygen hood placement, and will be measured in controls.

Comparison/Control Group The control cohort includes COVID-19 patients presenting for treatment prior to 4/3/20 when hyperbaric oxygen hoods were not available. Patients maintained on, or those failing on conventional O2- delivery systems and subsequently receiving mechanical ventilation will be studied.

All patients included must have tested positive using PCR swabs and/or been diagnosed based on clinical/laboratory standard diagnostic criteria. Medical management will include evolving treatment regimens and other standard medical treatments widely used at time of study in all hypoxic COVID-19 patients.

Prognostic/confounding covariates are to be collected through Electronic Medical Record (EMR) chart review and compared between intervention and control cohorts. including: Age, Body Mass Index (BMI), Gender, Chronic Lung disease - COPD, Asthma (CLD), cardiovascular disease - CAD, CHF, Chronic Dysrhythmia (CVD), chronic kidney disease (CKD), Immunosuppression - History of Cancer, Immunosuppressive medication, HIV (Immunosuppression), Diabetes Mellitus (DM), and pertinent lab markers.

Routine follow-up evaluation is maintained until final in-hospital outcomes are known including:

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Oxygen saturation

时间窗: 3/6/2020 - 5/1/2020

Continuous pulse oximetry monitoring

In-hospital Intubation/Mechanical Ventilation Status

时间窗: 3/6/2020 - 5/1/2020

Intubation/mechanical Ventilation at any point during hospitalization.

Length of Hospitalization

时间窗: 3/6/2020 - 5/1/2020

Duration of hospitalization

In-hospital Mortality

时间窗: 3/6/2020 - 5/1/2020

In-hospital Mortality status

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Dayya

Attending Physician

Northwell Health

研究点 (1)

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