Clinical Stabilization of Hypercapnia: NIPPV v HVNI (HYPERACT)

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

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].

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Dyspnea; Hypercapnic Respiratory Failure; Hypercapnic Acidosis
• Intervention / Treatment: Device: High Velocity Nasal Insufflation (HVNI); Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy Bergeski, MHA, RRT-NPS; Phone Number: 570-351-6966; Email: Abergeski@vtherm.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 91405
      • Valley Presbyterian Hospital
    • Oxnard, California, United States, 93030
      • Dignity Health - St. John's Regional Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Health System
  • Washington
    • Tacoma, Washington, United States, 98431
      • Madigan Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: High Velocity Nasal Insufflation (HVNI); The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.; Other Names: Vapotherm Precision Flow Plus
Active Comparator: 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.	Device: Noninvasive Positive Pressure Ventilation (NIPPV); The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.; Other Names: Philips Respironics V60

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Perception Score - Relief of Symptoms	Patient's subjective assessment of relief of their symptoms while on therapy, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.	Through study completion, an average of 4 hours
Patient Perception Score - Comfort/Tolerance	Patient's subjective assessment of their comfort and tolerance of therapy during the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.	Through study completion, an average of 4 hours
Clinician Perception Score - Expected/Perceived Outcomes	Clinician's subjective assessment of the expected and perceived patient outcomes as a result of therapy following testing, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.	At study end, 4 hours from study start
Clinician Perception Score - Patient Comfort/Tolerance	Clinician's subjective assessment of the patient's comfort and tolerance of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.	At study end, 4 hours from study start
Clinician Perception Score - Ease of Use	Clinician's subjective assessment of the ease of use of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.	At study end, 4 hours from study start

Collaborators and Investigators

• Sponsor: Vapotherm, Inc.
• Collaborators: University of Maryland; George Washington University; The Cooper Health System; Valley Presbyterian Hospital; Madigan Army Medical Center; Erlanger Baroness Hospital; Dignity Health - St. John's Regional Medical Center
• Investigators: Principal Investigator: Andrew Meltzer, MD, MS, George Washington University; Principal Investigator: Joshua Oliver, MD, Madigan Army Medical Hospital; Principal Investigator: Cynthia Pfeiffer, MD, Valley Presbyterian Hospital; Principal Investigator: Richard Wilkerson, MD, University of Maryland; Principal Investigator: David Yamane, MD, George Washington University; Principal Investigator: Christopher W Jones, MD, The Cooper Health System; Principal Investigator: Anthony Innabi, MBA, RRT-NPS, Dignity Health - St. John's Regional Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Actual): May 26, 2023
• Study Completion (Estimated): December 22, 2023

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Signs and Symptoms, Respiratory; Acid-Base Imbalance; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Dyspnea; Acidosis; Hypercapnia; Acidosis, Respiratory
• Other Study ID Numbers: RP-VTPF2020001Sci

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes