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临床试验/NCT04693403
NCT04693403已完成不适用

A Multicentre, Randomized, Clinical Trial of Respiratory Support With Standard Low Flow Oxygen Therapy, Continuous Positive Airway Pressure, and High-flow Oxygen Therapy in Adults With Acute Hypoxemic Respiratory Failure in Uganda

Makerere University18 个研究点 分布在 1 个国家目标入组 705 人开始时间: 2023年3月13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
705
试验地点
18
主要终点
Mortality

研究概览

简要总结

The dearth of Intensive care units in low resource settings portends for poor outcomes amongst patients with acute hypoxemic respiratory failure (AHRF) . To our knowledge, the effect of CPAP and HFNC on major outcomes has not been assessed in adults with AHRF in resource-limited settings. The aim of this prospective, multicenter, randomized, controlled, trial is to determine whether High-flow oxygen through a nasal cannula (HFNC) or Continuous positive airway pressure (CPAP) system can reduce mortality among patients with acute hypoxemic respiratory failure (AHRF) in a limited resource setting as compared with standard low flow oxygen therapy?

详细描述

The care for the critically ill patient typically takes place in the intensive care unit (ICU). ICU care is quite expensive, even in resource rich countries. The most common reason for ICU admission globally is respiratory support for acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality, especially in low income countries (LICs), given the scarce availability of invasive mechanical ventilation. Some studies suggest that administration of ventilatory support through a mask may be effective in resource-limited settings. However, there is no clinical study data in adults to support this evidence. Human and material constraints are major barriers for the care of critically-ill patients in resource limited settings , advocating the need for a frugal approach. Furthermore, the scarcity of intensive care unit care in LICs contributes to a high mortality among acutely ill patients. The current corona virus pandemic has further highlighted the need for frugal acute care interventions in LICs.

Continuous positive airway pressure (CPAP) is a simple to use and affordable technique for noninvasive ventilatory support. High-flow oxygen through a nasal cannula (HFNC) may also offer an alternative in patients with hypoxemia. The high flow rates may also decrease physiological dead space by flushing expired carbon dioxide from the upper airway, a process that potentially explains the observed decrease in the work of breathing.

Frugal CPAP or HFNC , as compared with standard oxygen therapy, could reduce the mortality among adults presenting with AHRF in a resource-limited setting.

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
None

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • De novo acute respiratory distress, as defined by dyspnea, use of accessory respiratory muscles, and a respiratory rate of 25 breaths per minute or more,
  • Hypoxemia, as defined by a ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of less than 300 mm Hg or a oxygen saturation by pulse oximetry SpO2/FiO2 ratio <315 will be considered for inclusion
  • Informed consent obtained in accordance with local regulations;

排除标准

  • Exacerbation of asthma, chronic obstructive pulmonary disease or another known or suspected chronic respiratory disease;
  • Absolute contraindications to CPAP or HFNC
  • Cardiac arrest; severe ventricular arrhythmia; shock defined by the need for vasopressors (dopamine > 5 microg/kg/min or adrenaline or noradrenaline at any dose)
  • Altered consciousness (Coma Glasgow Score below 12 points);
  • Do not intubate order, do not resuscitate order, or decision to limit full care taken before obtaining informed consent;
  • Refusal to participate, prior enrolment in the trial, participation in another interventional study on respiratory distress;

结局指标

主要结局

Mortality

时间窗: 28 day

Number of study participants deceased at day 28 of study randomisation

次要结局

  • Number of patients intubated and ventilator-free(28 days)
  • Patient Tolerance to CPAP or HFNC(7 days)
  • Organ failure free days(7 days)
  • Number of patients who meet criteria for intubation at day 7(7 days)

研究者

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

College of Health Sciences

Principal Investigator

Makerere University

研究点 (18)

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