High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- feasibility to perform a larger RCTperceived
研究概览
简要总结
In this pilot study the feasibility of performing a larger trial to study the non-inferiority of High Flow Nasal Oxygen compared to non-invasive ventilation in patients with acute acidotic hypercapnic exacerbation of COPD wil be investigated
详细描述
Rationale: Chronic Obstructive Pulmonary Disease (COPD) is frequently complicated by a worsening of symptoms, known as acute exacerbations (AECOPD). These exacerbations can result in a life-threatening condition with an impaired gas exchange, resulting in hypercapnia and as a result respiratory acidosis. The current standard of care of respiratory support for these patients is non-invasive ventilation (NIV), which has been shown to reduce morbidity and mortality. However, NIV is often unsuccessful, due to intolerance, agitation or patient-ventilation dyssynchrony. Furthermore, NIV is a resource-intensive therapy. High flow nasal oxygen (HFNO) is a non-invasive respiratory support mode that provides heated and humidified gas through soft nasal prongs. Several studies have shown that HFNO improves gas exchange and reduces work of breathing in non-hypercapnic respiratory failure. Furthermore, HFNO is thought to be better tolerated than NIV and the nursing effort may be lower compared to NIV. The hypothesis is that HFNO is non-inferior to NIV for patients with acidotic, hypercapnic AECOPD regarding the need for intubation and mortality, and that it increases patient comfort and reduces nursing effort.
Objective
To assess the feasibility of a larger study comparing HFNO with NIV as first line treatment in hypercapnic, acidotic AECOPD.
Study design: prospective, randomized, multi-center, unblinded, pilot study. Study population: Patients with acidotic, hypercapnic AECOPD Intervention (if applicable): HFNO versus NIV as first line treatment at presentation Main study parameters/endpoints: Feasibility: screening rate, inclusion rate, feasibility as qualified by staff and nurses.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All participating patients will receive standard of care (i.e., admission to the monitored ward or ICU for intensive monitoring and regular blood withdrawals, steroids, bronchodilator inhalation therapy). There will be one extra questionnaire after 3 months, but no extra blood samples or site visits, compared to regular care for the participating patients. Permission of the patient will be obtained to register date of hospital discharge and outcome after ICU discharge and ask them to fill out questionnaires at 3 months after admission about their quality of life. Previous studies have not shown that HFNO is inferior to NIV with regards to outcomes (intubation rate, mortality), albeit that they were not powered to prove non-inferiority.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known chronic obstructive pulmonary disease
- •Acute hypercapnic exacerbation of this condition, defined as: PaCO2>45 mmHg or >6.0 kPa and pH 7.20-7.35
- •Age >40 years
排除标准
- •Immediate need for intubation, based on clinical judgement of the attending physician.
- •Impossibility to apply either one of the two interventions
- •Patient not expected to give immediate or delayed informed consent (e.g. known cognitive impairment, dementia, active serious psychiatric disease, mental retardation).
- •Established home-NIV or home CPAP, known indication for home-NIV or CPAP (e.g. OSAS or obesitas hypoventilation syndrome).
- •Impeding death
- •Concurrent (respiratory) diseases that may influence treatment efficacy: acute heart infarction, cardiogenic lung edema, massive pulmonary embolism (intermediate-high risk or more). NB; pulmonary infections (viral and bacterial) are a common cause of exacerbation and are no reason for exclusion.
- •Other acute diseases that preclude participation in the trial such as hemodynamic instability (need for vasopressors), reduced consciousness with need for intubation, severe intoxication
- •Tracheostomized patients
- •Participation in other interventional trials
- •Impossibility to admit the patient to the participating ICU or monitored ward (e.g. medium care / high dependency unit, depending on local infrastructure).
- •Previous explicit (or written) objection to participation in research - bicarbonate <20 mmol/L
研究组 & 干预措施
High Flow Nasal Oxygen (HFNO)
Patients will start at a flow of 50 L/min and a temperature of 37°C, FiO2¬ will start at 25%, and titrated to target SpO2 (88-92%, as in usual care).
干预措施: HFNO (Other)
Non-Invasive Ventilation (NIV)
Patients will be started at
- Using the facemask interface: EPAP/PEEP set at 5-7 cmH2O and PS of 5-7 cmH2O (equal to IPAP of 10-14 cmH2O).
- Using the helmet interface; EPAP/PEEP set at least 10 cmH2O and PS of 10 cmH2O (equal to IPAP of 20 cmH2O).
- PEEP/EPAP and IPAP/PS can be titrated to effectiveness, tolerance and comfort
- FiO2 should be set to achieve a SpO2 of 88-92%
干预措施: NIV (Other)
结局指标
主要结局
feasibility to perform a larger RCTperceived
时间窗: 1 year
perceived feasibility as qualified by staff and nurses
feasibility to perform a larger RCT protocol deviations
时间窗: 1 year
protocol deviations
feasilibity to perform a larger RCT inclusion rate
时间窗: 1 year
Inclusion rate
feasibility to perform a larger RCT screening rate
时间窗: 1 year
Screening rate
次要结局
- 90d dyspnea MRC(90 days)
- 90d mortality(90 days)
- 90d anxiety and depression(90 days)
- duration of intervention(30 days)
- dyspnea score(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- secretions(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- need for intubation and mechanical ventilation(during ICU admission)
- Treatment failure(30 days)
- need for sedation(untill end of ICU admission)
- heart rate(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- respiratory rate(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- blood pressure(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- consciousness(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- agitation and sedation level(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- (dys)comfort score(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- HACOR score(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- blood gas(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- Clinical Parameters(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- HFNO ventilatory support parameters temperature(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- NIV ventilatory support parameters PEEP(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- NIV ventilatory support parameters PS(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- NIV ventilatory support parameters: FiO2(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- 30d mortality(30 days)
- 90d quality of life EQ5D(90 days)
- 90d quality of life SF36(90 days)
- SpO2(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- HFNO ventilatory support parameters flow(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- HFNO ventilatory support parameters FiO2(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- facial pressure sores(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- nursing effort(first 6 hours of study)
- nursing effort VAS(at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge)
- 90d PTDS(90 days)
- reason of treatment failure(during ICU admission)
- 90d PTSD(90 days)
- 90d dyspnea CCQ(90 days)
- expression of treatment failure(during ICU admission)
- need for switch to other modality(during ICU admission)