Clinical Stabilization of Hypercapnia: NIPPV v HVNI (HYPERACT)

August 6, 2024 updated by: Vapotherm, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rated Perceived Dyspnea [RPD]
Time Frame: 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.
During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Basic Metabolic Panel - Sodium
Time Frame: Baseline, at study start only
Sodium [Na+], measured in mEq/L
Baseline, at study start only
Patient Basic Metabolic Panel - Potassium
Time Frame: Baseline, at study start only
Potassium [K+], measured in mEq/L
Baseline, at study start only
Patient Basic Metabolic Panel - Chloride
Time Frame: Baseline, at study start only
Chloride [Cl-], measured in mEq/L
Baseline, at study start only
Patient Basic Metabolic Panel - Lactate
Time Frame: Baseline, at study start only
Lactate, measured in mEq/L
Baseline, at study start only
Patient Basic Metabolic Panel - Glucose
Time Frame: Baseline, at study start only
Glucose, measured in mg/dL
Baseline, at study start only
Patient Vital Signs - Heart Rate [HR]
Time Frame: During four time points in the study; Baseline, 30 min, 60 min, and 240 min
Heart rate, measured in beats per minute (bpm)
During four time points in the study; Baseline, 30 min, 60 min, and 240 min
Patient Vital Signs - Respiratory Rate [RR]
Time Frame: 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)
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]
Time Frame: 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 (%)
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
Time Frame: 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.
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
Time Frame: 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.
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 - Venous PCO2
Time Frame: 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
During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Patient Base Excess - Base Excess
Time Frame: 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
During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Patient Bicarbonate - Bicarbonate
Time Frame: 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
During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At study end, 4 hours from study start
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.
At study end, 4 hours from study start
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.
At study end, 4 hours from study start
Patient Perception Score - Relief of Symptoms
Time Frame: 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 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.
During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Patient Perception Score - Comfort/Tolerance
Time Frame: 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 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.
During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vapotherm, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 26, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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