Clinical Stabilization of Hypercapnia: NIPPV v HVNI (HYPERACT)

• ClinicalTrials.gov Identifier: NCT04709562
• Recruitment Status: Active, not recruiting
• First Posted: January 14, 2021
• Last Update Posted: June 13, 2023
• Sponsor: Vapotherm, Inc.
• Collaborators: Erlanger Baroness Hospital; The Cooper Health System; Dignity Health - St. John's Regional Medical Center; George Washington University; Madigan Army Medical Center; Valley Presbyterian Hospital; University of Maryland
• Information provided by (Responsible Party): Vapotherm, Inc.

Study Description

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].

Condition or disease	Intervention/treatment	Phase
Hypercapnic Respiratory Failure; Chronic Obstructive Pulmonary Disease; Dyspnea; Hypercapnic Acidosis	Device: High Velocity Nasal Insufflation (HVNI); Device: Noninvasive Positive Pressure Ventilation (NIPPV)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Hypercapnia Clinical Efficacy by NIPPV v HVNI: A Randomized Control Trial in the Stabilization of Acute Hypercarbic Respiratory Failure
• Actual Study Start Date: November 11, 2020
• Actual Primary Completion Date: May 26, 2023
• Estimated Study Completion Date: December 22, 2023

Arms and Interventions

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 Name: 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 Name: Philips Respironics V60

Outcome Measures

Primary Outcome Measures :

1. Rated Perceived Dyspnea [RPD] [ Time Frame: Through study completion, an average of 4 hours ]
   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 :

1. Patient Vital Signs - Heart Rate [HR] [ Time Frame: Through study completion, an average of 4 hours ]
   Heart rate, measured in beats per minute (bpm)
2. Patient Vital Signs - Respiratory Rate [RR] [ Time Frame: Through study completion, an average of 4 hours ]
   Respiratory rate, measured in breaths per minute (brpm)
3. Patient Vital Signs - Oxygen Saturation [SpO2] [ Time Frame: Through study completion, an average of 4 hours ]
   SpO2 measured as percentage of oxygen saturation (%)
4. Patient Vital Signs - Blood Pressure [BP] [ Time Frame: Through study completion, an average of 4 hours ]
   Blood pressure, measured in mmHg
5. Patient Communication Capability - Patient Stability Index [ Time Frame: Through study completion, an average of 4 hours ]
   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.
6. Patient Venous Blood Gas - pH [ Time Frame: Through study completion, an average of 4 hours ]
   pH, measured as units on a pH scale from 0 - 14. Neutral scores indicate a better outcome.
7. Patient Venous Blood Gas - Venous PCO2 [ Time Frame: Through study completion, an average of 4 hours ]
   Partial pressure of CO2 (PCO2), measured in mmHg
8. Patient Venous Blood Gas - Venous PO2 [ Time Frame: Through study completion, an average of 4 hours ]
   Partial pressure of venous oxygen (PO2), measured in mmHg
9. Patient Basic Metabolic Panel - Sodium [ Time Frame: Baseline, at study start only ]
   Sodium [Na+], measured in mEq/L
10. Patient Basic Metabolic Panel - Potassium [ Time Frame: Baseline, at study start only ]
    Potassium [K+], measured in mEq/L
11. Patient Basic Metabolic Panel - Chloride [ Time Frame: Baseline, at study start only ]
    Chloride [Cl-], measured in mEq/L
12. Patient Basic Metabolic Panel - Lactate [ Time Frame: Baseline, at study start only ]
    Lactate, measured in mEq/L
13. Patient Basic Metabolic Panel - Glucose [ Time Frame: Baseline, at study start only ]
    Glucose, measured in mg/dL
14. Patient Base Excess - Base Excess [ Time Frame: Through study completion, an average of 4 hours ]
    Base Excess, measured in mEq/L
15. Patient Bicarbonate - Bicarbonate [ Time Frame: Through study completion, an average of 4 hours ]
    Bicarbonate, measured in mEq/L

Other Outcome Measures:

1. Patient Perception Score - Relief of Symptoms [ Time Frame: Through study completion, an average of 4 hours ]
   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.
2. Patient Perception Score - Comfort/Tolerance [ Time Frame: Through study completion, an average of 4 hours ]
   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.
3. Clinician Perception Score - Expected/Perceived Outcomes [ Time Frame: At study end, 4 hours from study start ]
   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.
4. Clinician Perception Score - Patient Comfort/Tolerance [ Time Frame: At study end, 4 hours from study start ]
   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.
5. Clinician Perception Score - Ease of Use [ Time Frame: At study end, 4 hours from study start ]
   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.

Eligibility Criteria

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

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
• 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

Contacts and Locations

Locations

United States, California

Valley Presbyterian Hospital

Los Angeles, California, United States, 91405

Dignity Health - St. John's Regional Medical Center

Oxnard, California, United States, 93030

United States, District of Columbia

George Washington University Hospital

Washington, District of Columbia, United States, 20037

United States, Maryland

University of Maryland

Baltimore, Maryland, United States, 21201

United States, New Jersey

Cooper University Hospital

Camden, New Jersey, United States, 08103

United States, Tennessee

Erlanger Health System

Chattanooga, Tennessee, United States, 37403

United States, Washington

Madigan Army Medical Center

Tacoma, Washington, United States, 98431

Sponsors and Collaborators

Vapotherm, Inc.

Erlanger Baroness Hospital

The Cooper Health System

Dignity Health - St. John's Regional Medical Center

George Washington University

Madigan Army Medical Center

Valley Presbyterian Hospital

University of Maryland

Investigators

• Principal Investigator: Andrew Meltzer, MD, MS; 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
• 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

More Information

• Responsible Party: Vapotherm, Inc.
• ClinicalTrials.gov Identifier: NCT04709562
• Other Study ID Numbers: RP-VTPF2020001Sci
• First Posted: January 14, 2021
• Last Update Posted: June 13, 2023
• Last Verified: June 2023

• 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

Additional relevant MeSH terms:

Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Dyspnea; Acidosis, Respiratory; Acidosis; Hypercapnia; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Respiration Disorders; Signs and Symptoms, Respiratory; Acid-Base Imbalance; Metabolic Diseases