Clinical Stabilization of Hypercapnia: NIPPV v HVNI

Not Applicable

Completed

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

Interventions: Device: High Velocity Nasal Insufflation (HVNI)
Device: Noninvasive Positive Pressure Ventilation (NIPPV)

Registration Number: NCT04709562

Lead Sponsor: Vapotherm, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 68

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Velocity Nasal Insufflation (HVNI)	High Velocity Nasal Insufflation (HVNI)	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.
Noninvasive Positive Pressure Ventilation (NIPPV)	Noninvasive Positive Pressure Ventilation (NIPPV)	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.

Primary Outcome Measures

Name	Time	Method
Rated Perceived Dyspnea [RPD]	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 Outcome Measures

Name	Time	Method
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 stability index, measured by patient's ability to speak in full sentences, rated on a 0-100 scale. Higher scores indicate a better outcome.
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	Partial pressure of CO2 (PCO2), measured in mmHg
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	Respiratory rate, measured in breaths per minute (brpm)
Patient Bicarbonate - Bicarbonate	During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min	Bicarbonate, measured in mEq/L
Patient Basic Metabolic Panel - Sodium	Baseline, at study start only	Sodium \[Na+\], measured in mEq/L
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	SpO2 measured as percentage of oxygen saturation (%)
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	pH, measured as units on a pH scale from 0 - 14. Neutral scores indicate a better outcome.
Patient Vital Signs - Heart Rate [HR]	During four time points in the study; Baseline, 30 min, 60 min, and 240 min	Heart rate, measured in beats per minute (bpm)
Patient Basic Metabolic Panel - Potassium	Baseline, at study start only	Potassium \[K+\], measured in mEq/L
Patient Basic Metabolic Panel - Chloride	Baseline, at study start only	Chloride \[Cl-\], measured in mEq/L
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	Base Excess, measured in mEq/L
Patient Basic Metabolic Panel - Lactate	Baseline, at study start only	Lactate, measured in mEq/L
Patient Basic Metabolic Panel - Glucose	Baseline, at study start only	Glucose, measured in mg/dL

Trial Locations

Locations (7): Valley Presbyterian Hospital
🇺🇸
Los Angeles, California, United States
University of Maryland
🇺🇸
Baltimore, Maryland, United States
George Washington University Hospital
🇺🇸
Washington, District of Columbia, United States
Cooper University Hospital
🇺🇸
Camden, New Jersey, United States
Erlanger Health System
🇺🇸
Chattanooga, Tennessee, United States
Dignity Health - St. John's Regional Medical Center
🇺🇸
Oxnard, California, United States
Madigan Army Medical Center
🇺🇸
Tacoma, Washington, United States