Investigating the Role of Gas Flow in Transnasal Pulmonary Aerosol Delivery Via Nasal Cannula: A Double-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The number of patients who meet the positive criteria of responding to albuterol at the dose of 1.5 mg
研究概览
简要总结
Aerosol delivery via nasal cannula has gained increasing popularity, due to its combined benefits from aerosolized medication and heated warm oxygen therapy. In our previous in vitro study, we investigated the effects of the ratio of nasal cannula gas flow to subject's peak inspiratory flow (GF: IF) on the aerosol lung deposition, and we found that aerosol deposition in lung increased as the GF: IF decreased with an optimal GF: IF between 0.1 to 0.5 producing a stable "lung" deposition in both quiet and distress breathing. Thus we aimed to further validate such an optimal GF: IF in patients with reversible airflow limitations by the delivery of bronchodilators. Adult COPD or asthma patients who met ATS/ERS criteria for bronchodilator response in pulmonary function lab will be recruited and consented. After a washout period (1-3 days), patients will receive an escalating doubling dosage (0.5, 1, 2, and 4mg) of albuterol in total volume of 2mL, delivered by mesh nebulizer via nasal cannula. Patients will be randomly assigned to inhale bronchodilator into 3 group using different flows: 50 L/min,GF: IF = 1.0, and GF: IF = 0.5.
详细描述
Introduction Both in vitro and in vivo radiolabeled studies on nebulization via high flow nasal cannula (HFNC) showed that aerosol lung deposition decreased with the increasing nasal cannula gas flow, which, however, was not observed in patients with distressed breathing. In our previous in vitro study, we investigated the effects of the ratio of nasal cannula gas flow to subject's peak inspiratory flow (GF: IF) on the aerosol lung deposition, and we found that aerosol deposition in lung increased as the GF: IF decreased with an optimal GF: IF between 0.1 to 0.5 producing a stable "lung" deposition in both quiet and distress breathing. Thus we aimed to further validate such an optimal GF: IF in patients with reversible airflow limitations by the delivery of bronchodilators.
Methods and analysis COPD and asthma patients with positive response to four actuations of albuterol via metered dose inhaler (MDI) and valved holding chamber (VHC) will be enrolled and consented in the study. After a washout period (1-3 days), patients will be randomly assigned to three groups with different nasal cannula gas flow: 50L/min, GF: IF = 1.0, and GF: IF = 0.5. In each treatment arm, patients will firstly receive saline, then followed by an escalating doubling dosages (0.5, 1, 2, and 4mg) of albuterol in a total volume of 2mL, delivered by mesh nebulizer (VMN, Aerogen, Ireland) via heated nasal cannula at 37℃. An interval of 30 min will be maintained between two doses of albuterol, and pulmonary spirometry will be measured at baseline and after each dose. Titration will be terminated when an additional FEV1 improvement was < 5%.
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
- Double (Participant, Care Provider)
盲法说明
Nebulization will be offered in a one room and pulmonary function test will be performed in the other room. Both patients and the pulmonary function test technician will be masked to the group.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with positive bronchodilator responses to four actuations of albuterol (Ventolin, GSK, UK) via MDI with VHC (OptiChamber Diamond, Philips, USA) will be eligible for enrollment. A positive bronchodilator response is defined in accordance with ATS/ERS guidelines as follows: an increase in FEV1 of ≥ 12% and absolute change ≥ 200 mL from baseline.
排除标准
- •age ≥ 90 years old;
- •pregnancy;
- •pulmonary exacerbation within two weeks before enrollment;
- •reluctant to participate;
- •inability to complete the follow-up spirometry after each bronchodilator inhalation;
- •resting heart rate > 100bpm;
- •resting systolic blood pressure > 160mmHg or diastolic blood pressure > 110mmHg.
结局指标
主要结局
The number of patients who meet the positive criteria of responding to albuterol at the dose of 1.5 mg
时间窗: 60 minutes
The number of patients in HFNC nebulization who respond to albuterol at the dose of 1.5mg
The number of patients who meet the positive criteria of responding to albuterol at the dose of 0.5mg
时间窗: 30 minutes
The number of patients in HFNC nebulization who respond to albuterol at the dose of 0.5mg
The number of patients who meet the positive criteria of responding to albuterol at the dose of 3.5 mg
时间窗: 90 minutes
The number of patients in HFNC nebulization who respond to albuterol at the dose of 3.5mg
The number of patients who meet the positive criteria of responding to albuterol at the dose of 7.5mg
时间窗: 120 minutes
The number of patients in HFNC nebulization who respond to albuterol at the dose of 7.5mg
次要结局
- the incidence of side effect (tremor) in each group(120 minutes)
- the accumulative dose of albuterol required across groups to produce positive bronchodilation effects(120 minutes)
- the incidence of side effect (tachycardia) in each group(120 minutes)