Clinical Stabilization of Hypercapnia: NIPPV v HVNI

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hypercapnia Clinical Efficacy by NIPPV v HVNI: A Randomized Control Trial in the Stabilization of Acute Hypercarbic Respiratory Failure

Conditions
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Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Dyspnea, Hypercapnic Acidosis

Intervention / Treatment
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* Device: High Velocity Nasal Insufflation (HVNI)
* Device: Noninvasive Positive Pressure Ventilation (NIPPV)


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Velocity Nasal Insufflation (HVNI)<br>Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded. | Device: High Velocity Nasal Insufflation (HVNI)<br>* The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.<br>* Other names: Vapotherm Precision Flow Plus;|
| Active Comparator: Noninvasive Positive Pressure Ventilation (NIPPV)<br>Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded. | Device: Noninvasive Positive Pressure Ventilation (NIPPV)<br>* The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.<br>* Other names: Philips Respironics V60;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rated Perceived Dyspnea [RPD] | 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. | Through study completion, an average of 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Vital Signs - Heart Rate [HR] | Heart rate, measured in beats per minute (bpm) | Through study completion, an average of 4 hours | 
| Patient Vital Signs - Respiratory Rate [RR] | Respiratory rate, measured in breaths per minute (brpm) | Through study completion, an average of 4 hours | 
| Patient Vital Signs - Oxygen Saturation [SpO2] | SpO2 measured as percentage of oxygen saturation (%) | Through study completion, an average of 4 hours | 
| Patient Vital Signs - Blood Pressure [BP] | Blood pressure, measured in mmHg | Through study completion, an average of 4 hours | 
| Patient Communication Capability - Patient Stability Index | Patient stability index, measured by patient's ability to speak in full sentences, rated on a 0-10 scale. Higher scores indicate a better outcome. | Through study completion, an average of 4 hours | 
| Patient Venous Blood Gas - pH | pH, measured as units on a pH scale from 0 - 14. Neutral scores indicate a better outcome. | Through study completion, an average of 4 hours | 
| Patient Venous Blood Gas - Venous PCO2 | Partial pressure of CO2 (PCO2), measured in mmHg | Through study completion, an average of 4 hours | 
| Patient Venous Blood Gas - Venous PO2 | Partial pressure of venous oxygen (PO2), measured in mmHg | Through study completion, an average of 4 hours | 
| Patient Basic Metabolic Panel - Sodium | Sodium [Na+], measured in mEq/L | Baseline, at study start only | 
| Patient Basic Metabolic Panel - Potassium | Potassium [K+], measured in mEq/L | Baseline, at study start only | 
| Patient Basic Metabolic Panel - Chloride | Chloride [Cl-], measured in mEq/L | Baseline, at study start only | 
| Patient Basic Metabolic Panel - Lactate | Lactate, measured in mEq/L | Baseline, at study start only | 
| Patient Basic Metabolic Panel - Glucose | Glucose, measured in mg/dL | Baseline, at study start only | 
| Patient Base Excess - Base Excess | Base Excess, measured in mEq/L | Through study completion, an average of 4 hours | 
| Patient Bicarbonate - Bicarbonate | Bicarbonate, measured in mEq/L | Through study completion, an average of 4 hours |