Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Device Equivalence
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 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 a new High Velocity Nasal Insufflation [HVNI] device design to effect ventilation and related physiological responses relative to the current HVNI device design.
详细描述
The objective of this study is to evaluate the ability of a new HVNI device to improve ventilation, dyspnea, and related physiological responses relative to the conventional Precision Flow device design, with which there are published clinical outcomes data. It is hypothesized that the new HVNI device design (V2.0) will be comparable at relieving patient dyspnea when compared to the conventional HVNI device design (Precision Flow).
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
- None
盲法说明
This trial is non-blinded by necessity, as there are distinct differences in size and appearance between the new and current HVNI device designs.
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 inpatients (18 years of age and older)
- •Demonstrated severe dyspnea at baseline (Borg Rated Perceived Dyspnea [RPD] (scale 0-10) of 3 or higher)
- •Severe baseline hypercarbia/hypercapnia of 55 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
- •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 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: Through study completion, an average of 1.6 hours
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](Through study completion, an average of 1.6 hours)
- Patient Vital Signs - Respiratory Rate [RR](Through study completion, an average of 1.6 hours)
- Patient Vital Signs - Transcutaneous CO2 [TcPCO2](Through study completion, an average of 1.6 hours)
- Patient Vital Signs - Arterial Oxygen Saturation [SpO2](Through study completion, an average of 1.6 hours)
- Patient Vital Signs - Blood Pressure [BP](Through study completion, an average of 1.6 hours)