Hypercapnia Clinical Efficacy by NIPPV v HVNI: A Randomized Control Trial in the Stabilization of Acute Hypercarbic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 14
- 主要终点
- Rated Perceived Dyspnea [RPD]
研究概览
简要总结
This study will evaluate the ability of High Velocity Nasal Insufflation [HVNI] to effect ventilation and related physiologic responses in hypercapnic patients when compared to noninvasive positive pressure ventilation [NIPPV].
详细描述
The overall objective of this randomized study is to evaluate the efficacy of HVNI, in comparison to NIPPV, to clinically stabilize and provide respiratory therapy to patients who have COPD with moderate-to-severe hypercapnic respiratory distress upon presentation. It is hypothesized that HVNI is comparable to NIPPV in the stabilization and relief of moderate-to-severe hypercapnic respiratory distress upon presentation, by relieving the patient's dyspnea (breathlessness) within 4 hours to a comparable degree to NIPPV.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults, 18 years or older with a known or suspected diagnosis of COPD
- •Presentation with acute hypercapnic respiratory failure
- •Moderate to Severe patient baseline hypercarbia/hypercapnia, defined as a baseline PCO2 of 60 mmHg or higher
- •Venous pH of 7.0 - 7.35
排除标准
- •Severe metabolic derangements (e.g. suspected drug overdose, mixed acid/base disorder)
- •Need for airway protection
- •Primary condition of Congestive Heart Failure
- •Need for emergent intubation
- •Pneumonia diagnosis with significant infiltrate on chest x-ray that is clinically correlated with pneumonia
- •Inability to provide informed consent
- •Pregnancy
- •Known contraindication to perform procedures listed, or therapies described in the protocol
- •Respiratory arrest or significant respiratory depression on presentation
- •Significant nasal occlusion either unilateral or bilateral
- •Absence of spontaneous respiration or known contraindication to HVNI
- •Extreme agitation or uncooperativeness that would hinder either arm of randomized therapy
- •Determined by the clinician to be sufficiently unstable or unsuitable for this study
结局指标
主要结局
Rated Perceived Dyspnea [RPD]
时间窗: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 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 Communication Capability - Patient Stability Index(During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min)
- Patient Venous Blood Gas - Venous PCO2(During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min)
- Patient Vital Signs - Respiratory Rate [RR](During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min)
- Patient Bicarbonate - Bicarbonate(During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min)
- Patient Vital Signs - Oxygen Saturation [SpO2](During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min)
- Patient Venous Blood Gas - pH(During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min)
- Patient Basic Metabolic Panel - Sodium(Baseline, at study start only)
- Patient Vital Signs - Heart Rate [HR](During four time points in the study; Baseline, 30 min, 60 min, and 240 min)
- Patient Basic Metabolic Panel - Potassium(Baseline, at study start only)
- Patient Basic Metabolic Panel - Chloride(Baseline, at study start only)
- Patient Base Excess - Base Excess(During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min)
- Patient Basic Metabolic Panel - Lactate(Baseline, at study start only)
- Patient Basic Metabolic Panel - Glucose(Baseline, at study start only)