Clinical Stabilization of Hypercapnia: NIPPV v HVNI

Vapotherm, Inc.68 enrolled

Overview

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 \[NIPPV\].

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypercapnic Respiratory Failure Chronic Obstructive Pulmonary Disease Dyspnea Hypercapnic Acidosis

Interventions

High Velocity Nasal Insufflation (HVNI)DEVICE

The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.

Noninvasive Positive Pressure Ventilation (NIPPV)DEVICE

The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (7)

Valley Presbyterian Hospital

Los Angeles, California, United States

Dignity Health - St. John's Regional Medical Center

Oxnard, California, United States

George Washington University Hospital

Washington D.C., District of Columbia, United States

University of Maryland

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

Secondary Outcomes

Patient Vital Signs - Heart Rate [HR]

Heart rate, measured in beats per minute (bpm)

Time frame: During four time points in the study; Baseline, 30 min, 60 min, and 240 min

Patient Vital Signs - Respiratory Rate [RR]

Respiratory rate, measured in breaths per minute (brpm)

Time frame: 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]

SpO2 measured as percentage of oxygen saturation (%)

Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

Patient Communication Capability - Patient Stability Index

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.

Time frame: 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

pH, measured as units on a pH scale from 0 - 14. Neutral scores indicate a better outcome.

Time frame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

Data from ClinicalTrials.gov

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