Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Patient Vital Signs -- Rated Perceived Dyspnea (RPD)
研究概览
简要总结
This study will evaluate the ability of High Velocity Nasal Insufflation [HVNI] next generation nasal cannula designs to effect ventilation and related physiological responses relative to the conventional legacy cannula design.
详细描述
The objective of this study is to evaluate the ability of HVNI next generation nasal cannula designs to effect ventilation and related physiological responses relative to the current cannula design, with which there are published clinical outcomes data. It is hypothesized that next generation nasal cannula designs (Prosoft and Unicorn) will be comparable at relieving patient dyspnea while on HVNI, when compared to the conventional (Legacy) cannula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Adults, 18 years or older
- •Demonstrated severe dyspnea at baseline (Borg Rated Perceived Dyspnea [RPD] (scale 0-10) of 3 or higher)
- •Severe baseline hypercarbia/hypercapnia of 50 mmHg or higher as measured by TcPCo2 or arterial or venous blood gas
排除标准
- •Patient has unstable cardiovascular condition
- •Significant unilateral or bilateral nasal occlusion
- •Vigorous physical activity should not be performed within 2 hours of testing
- •Inability to provide informed consent
- •Pregnancy
- •Known contraindication to perform steps of the protocol
- •Absence of spontaneous respiration or known contraindication to HVNI
- •Inability to use nasal cannula and HVNI therapy
- •Agitation or uncooperativeness
- •Determined by the clinician to be sufficiently unstable or unsuitable for this study
结局指标
主要结局
Patient Vital Signs -- Rated Perceived Dyspnea (RPD)
时间窗: This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)
Patient's subjective assessment of their dyspnea, rated as a modified Borg score on a scale from 0 to 10. Higher scores indicate a worse outcome.
次要结局
- Patient Vital Signs - Heart Rate [HR](This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min))
- Patient Vital Signs - Respiratory Rate [RR](This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min))
- Patient Vital Signs - Arterial Oxygen Saturation [SpO2](This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min))
- Patient Vital Signs - Blood Pressure [BP](This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min))
- Patient Vital Signs - Transcutaneous CO2 [TcPCO2](This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min))