Hypercapnia Clinical Efficacy by NIPPV v HVNI: A Randomized Control Trial in the Stabilization of Acute Hypercarbic Respiratory Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypercapnic Respiratory Failure
- Sponsor
- Vapotherm, Inc.
- Enrollment
- 68
- Locations
- 7
- Primary Endpoint
- Rated Perceived Dyspnea [RPD]
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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].
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Rated Perceived Dyspnea [RPD]
Time Frame: 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.
Secondary Outcomes
- 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)