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临床试验/NCT04560257
NCT04560257Unknown不适用

Prone Positioning and High Flow Nasal Canula (HFNC) Therapy: A Game Changer in COVID-19 Outcome

Lahore General Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Clinical response of HFNC

研究概览

简要总结

Many non-invasive ventilatory choices are available for COVID-19 patient who are having mild to moderate respiratory distress and their use will decrease the chance of ICU admission, intubation and mechanical ventilation in severe cases of COVID-19. However, all these respiratory supports and oxygen supply devices are aerosol generating and their selection should be precised enough to control nosocomial spread.

High flow nasal cannula HFNC is a device that delivered the warmed and humid air on high flow rate through nose. It is used to treat severe respiratory distress in COVID-19 patients, a non-invasive ventilatory approach which is relative comfortable by using humidified and pre-heated air containing large concentration of oxygen. In acute respiratory failure HFNC is proven to be very effective and it also reduced the need of mechanical ventilation in severe patients. Apart from the supply of oxygen, HFNC generating positive airway pressure and decreasing the rebreathing from anatomical dead space.

Prone position is also a save therapy and has been proven to be effective for refractory hypoxia by increasing tidal volume, oxygenation and diaphragmatic functions in ARDS patients. Recent studies showed that prone positioning and HFNC might avoid the prerequisite of intubation in moderate to severe patients of ARDS and as a result it decreases the nosocomial infection in physicians who are doing these aerosol generating procedures.

详细描述

This is observational single-center study, that will be done at Lahore General Hospital in which 95 beds are allocated for COVID-19 patients including ICUs and HDUs. Ethical approval will be obtained from research ethical committee of Lahore General hospital, Lahore. Informed consent will be obtained from all patients who will agree to publish their data in this research. We will protect patient's privacy and obey with the Helsinki Declaration.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients of > 18 years of ages, males and females who will be diagnosed COVID-19 positive by RT-PCR with moderate illness.
  • Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest.
  • Respiratory rate > 30/ min and not responding to non-rebreather masks.
  • COVID-related pneumonia requiring non-invasive ventilatory support (high-flow nasal cannula, and / or non-invasive ventilation and / or CPAP)

排除标准

  • Inability to provide consent;
  • Severe respiratory failure requiring invasive ventilatory support;
  • Indication of immediate tracheal intubation
  • Significant acute progressive circulatory insufficiency
  • Impaired alertness, confusion, restlessness
  • Chest trauma or other contraindication to prone position
  • Pneumothorax
  • Nasal blockade
  • Unable to tolerate high flow oxygen

结局指标

主要结局

Clinical response of HFNC

时间窗: 10 days

The number of patients treated with non-invasive ventilation devices. HFNC related events (hot air feeling, nasal lesions)

次要结局

  • Radiological outcome(15 days)
  • Supplemental Oxygen Requirement from Baseline(15 days)
  • Duration of intervention(15 days)
  • Duration of hospitalization(15 days)

研究者

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

Dr. M.Irfan Malik

Associate Professor of Pulmonology / Focal Person COVID-19

Lahore General Hospital

研究点 (2)

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