search
Back to results

Clinical Stabilization of Hypercapnia: NIPPV v HVNI (HYPERACT)

Primary Purpose

Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Dyspnea

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Velocity Nasal Insufflation (HVNI)
Noninvasive Positive Pressure Ventilation (NIPPV)
Sponsored by
Vapotherm, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercapnic Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Valley Presbyterian Hospital
  • Dignity Health - St. John's Regional Medical Center
  • George Washington University Hospital
  • University of Maryland
  • Cooper University Hospital
  • Erlanger Health System
  • Madigan Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Velocity Nasal Insufflation (HVNI)

Noninvasive Positive Pressure Ventilation (NIPPV)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient Vital Signs - Heart Rate [HR]
Heart rate, measured in beats per minute (bpm)
Patient Vital Signs - Respiratory Rate [RR]
Respiratory rate, measured in breaths per minute (brpm)
Patient Vital Signs - Oxygen Saturation [SpO2]
SpO2 measured as percentage of oxygen saturation (%)
Patient Vital Signs - Blood Pressure [BP]
Blood pressure, measured in mmHg
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.
Patient Venous Blood Gas - pH
pH, measured as units on a pH scale from 0 - 14. Neutral scores indicate a better outcome.
Patient Venous Blood Gas - Venous PCO2
Partial pressure of CO2 (PCO2), measured in mmHg
Patient Venous Blood Gas - Venous PO2
Partial pressure of venous oxygen (PO2), measured in mmHg
Patient Basic Metabolic Panel - Sodium
Sodium [Na+], measured in mEq/L
Patient Basic Metabolic Panel - Potassium
Potassium [K+], measured in mEq/L
Patient Basic Metabolic Panel - Chloride
Chloride [Cl-], measured in mEq/L
Patient Basic Metabolic Panel - Lactate
Lactate, measured in mEq/L
Patient Basic Metabolic Panel - Glucose
Glucose, measured in mg/dL
Patient Base Excess - Base Excess
Base Excess, measured in mEq/L
Patient Bicarbonate - Bicarbonate
Bicarbonate, measured in mEq/L

Full Information

First Posted
January 7, 2021
Last Updated
June 12, 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
search

1. Study Identification

Unique Protocol Identification Number
NCT04709562
Brief Title
Clinical Stabilization of Hypercapnia: NIPPV v HVNI
Acronym
HYPERACT
Official Title
Hypercapnia Clinical Efficacy by NIPPV v HVNI: A Randomized Control Trial in the Stabilization of Acute Hypercarbic Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
May 26, 2023 (Actual)
Study Completion Date
December 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

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
Data Monitoring Committee
No

5. 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].
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Dyspnea, Hypercapnic Acidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Velocity Nasal Insufflation (HVNI)
Arm Type
Experimental
Arm Description
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.
Arm Title
Noninvasive Positive Pressure Ventilation (NIPPV)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High Velocity Nasal Insufflation (HVNI)
Other Intervention Name(s)
Vapotherm Precision Flow Plus
Intervention Description
The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
Intervention Type
Device
Intervention Name(s)
Noninvasive Positive Pressure Ventilation (NIPPV)
Other Intervention Name(s)
Philips Respironics V60
Intervention Description
The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
Primary Outcome Measure Information:
Title
Rated Perceived Dyspnea [RPD]
Description
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
Through study completion, an average of 4 hours
Secondary Outcome Measure Information:
Title
Patient Vital Signs - Heart Rate [HR]
Description
Heart rate, measured in beats per minute (bpm)
Time Frame
Through study completion, an average of 4 hours
Title
Patient Vital Signs - Respiratory Rate [RR]
Description
Respiratory rate, measured in breaths per minute (brpm)
Time Frame
Through study completion, an average of 4 hours
Title
Patient Vital Signs - Oxygen Saturation [SpO2]
Description
SpO2 measured as percentage of oxygen saturation (%)
Time Frame
Through study completion, an average of 4 hours
Title
Patient Vital Signs - Blood Pressure [BP]
Description
Blood pressure, measured in mmHg
Time Frame
Through study completion, an average of 4 hours
Title
Patient Communication Capability - Patient Stability Index
Description
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.
Time Frame
Through study completion, an average of 4 hours
Title
Patient Venous Blood Gas - pH
Description
pH, measured as units on a pH scale from 0 - 14. Neutral scores indicate a better outcome.
Time Frame
Through study completion, an average of 4 hours
Title
Patient Venous Blood Gas - Venous PCO2
Description
Partial pressure of CO2 (PCO2), measured in mmHg
Time Frame
Through study completion, an average of 4 hours
Title
Patient Venous Blood Gas - Venous PO2
Description
Partial pressure of venous oxygen (PO2), measured in mmHg
Time Frame
Through study completion, an average of 4 hours
Title
Patient Basic Metabolic Panel - Sodium
Description
Sodium [Na+], measured in mEq/L
Time Frame
Baseline, at study start only
Title
Patient Basic Metabolic Panel - Potassium
Description
Potassium [K+], measured in mEq/L
Time Frame
Baseline, at study start only
Title
Patient Basic Metabolic Panel - Chloride
Description
Chloride [Cl-], measured in mEq/L
Time Frame
Baseline, at study start only
Title
Patient Basic Metabolic Panel - Lactate
Description
Lactate, measured in mEq/L
Time Frame
Baseline, at study start only
Title
Patient Basic Metabolic Panel - Glucose
Description
Glucose, measured in mg/dL
Time Frame
Baseline, at study start only
Title
Patient Base Excess - Base Excess
Description
Base Excess, measured in mEq/L
Time Frame
Through study completion, an average of 4 hours
Title
Patient Bicarbonate - Bicarbonate
Description
Bicarbonate, measured in mEq/L
Time Frame
Through study completion, an average of 4 hours
Other Pre-specified Outcome Measures:
Title
Patient Perception Score - Relief of Symptoms
Description
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.
Time Frame
Through study completion, an average of 4 hours
Title
Patient Perception Score - Comfort/Tolerance
Description
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.
Time Frame
Through study completion, an average of 4 hours
Title
Clinician Perception Score - Expected/Perceived Outcomes
Description
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.
Time Frame
At study end, 4 hours from study start
Title
Clinician Perception Score - Patient Comfort/Tolerance
Description
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.
Time Frame
At study end, 4 hours from study start
Title
Clinician Perception Score - Ease of Use
Description
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.
Time Frame
At study end, 4 hours from study start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Meltzer, MD, MS
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher W Jones, MD
Organizational Affiliation
The Cooper Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anthony Innabi, MBA, RRT-NPS
Organizational Affiliation
Dignity Health - St. John's Regional Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joshua Oliver, MD
Organizational Affiliation
Madigan Army Medical Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cynthia Pfeiffer, MD
Organizational Affiliation
Valley Presbyterian Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Wilkerson, MD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Yamane, MD
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valley Presbyterian Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
91405
Country
United States
Facility Name
Dignity Health - St. John's Regional Medical Center
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
George Washington University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Erlanger Health System
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Stabilization of Hypercapnia: NIPPV v HVNI

We'll reach out to this number within 24 hrs