High Flow Nasal Cannula Therapy for Initial Oxygen Administration in Acute Hypercapnic Respiratory Failure - A Comparison Study of Two Current Standards of Care
试验速览
- 阶段
- 不适用
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Proportion of patients requiring NIV in each cohort
研究概览
简要总结
Chronic lung conditions such as smoking related lung damage lead to breathing fail. This results in accumulation of gases such as carbon-di-oxide in the body especially during periods of illness known as exacerbation.
Current management of carbon-di-oxide accumulation is administration of oxygen, nebulisers, antibiotics etc and if necessary, provide a tight fitting mask around the face to provide breathing support. If this fails, then a patient is placed on a mechanical ventilator. The tight fitting mask therapy is also called non-invasive ventilation and is used widely but patients acceptability of the therapy is limited.
Providing a high flow of air with some oxygen could potentially provide the same benefit of the non-invasive ventilation and may also be better accepted by patients.
Currently the knowledge and evidence from studies suggest a beneficial role for this high flow therapy but this has not been investigated in well designed studies.
In the proposed study we aim to investigate whether use of the high flow therapy reduces the need for non-invasive ventilation in patients who present with a recent onset accumulation of carbon-di-oxide in their body due to long-term lung disease. If this shows benefit, it will lead to a bigger trial with patient benefiting by reduction in the non-invasive ventilation or indeed a need for an invasive breathing machine.
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 (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, the participants , care provider and investigator cannot be blinded but the outcome is objective and data will be analyzed by statistician independent of the study team.
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
- •Adult patients > 18 years of age
- •Acute Hypercapnic respiratory failure with pH < 7.35 and pCO2 > 6 KPa
排除标准
- •Age < 18 years
- •Pregnant or Breast-Feeding
- •Patient cannot read and understand English
- •Hypercapnia secondary to a drug toxicity or non-pulmonary aetiology
- •Hypercapnia secondary to exacerbation of asthma
- •Contraindication to NIV
- •Contraindication to HFNC
- •Not for escalation to NIV
- •GCS 8 or less
- •Shock defined as systolic < 90 mmHg or a reduction by 20mmHg from usual systolic BP despite volume resuscitation
- •Respiratory or cardio-respiratory arrest
- •Any other indication that requires immediate invasive/non-invasive mechanical ventilation
结局指标
主要结局
Proportion of patients requiring NIV in each cohort
时间窗: 6 hours
Proportion of patients who require NIV by 6 hours of intervention.
次要结局
- Respiratory rate (Breath/minute)(At 1 hour, 6 hours and 24 hours.)
- Hospital length of stay(From the date of randomization until hospital discharge or date of death from any cause, whichever came first, assessed up to 12 weeks.)
- Heart rate (Beat/minute)(1 hour, 6 hours and 24 hours.)
- Mean arterial pressure in millimeters of mercury(1 hour, 6 hours and 24 hours.)
- In-hospital mortality(From the date of randomization until the date of death or hospital discharge, whichever came first, assessed up to 12 weeks.)
- ICU length of stay(From the date of ICU admission until the date of last documented ICU discharge or date of death from any cause, whichever came first, assessed up to 12 weeks.)
- PaO2 in Kilopascal(1 hour, 6 hours and 24 hours.)
- pH(1 hour, 6 hours and 24 hours.)
- Intubation rate(1 hour, 6 hours and 24 hours.)
- ICU admission(From the date of randomization until the date of first documented admission to ICU, assessed up to 12 weeks.)
- PaCO2 in Kilopascal(1 hour, 6 hours and 24 hours.)
- Dyspnoea(1 hour, 6 hours and 24 hours.)
- Patient comfort(1 hour.)