Hypercapnic Respiratory FailureHYPERACTNCT04709562

Clinical Stabilization of Hypercapnia: NIPPV v HVNI

A study testing High Velocity Nasal Insufflation (HVNI) and Noninvasive Positive Pressure Ventilation (NIPPV) in people with Hypercapnic Respiratory Failure and Chronic Obstructive Pulmonary Disease, run by Vapotherm, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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]. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Dyspnea
What is being tested?: High Velocity Nasal Insufflation (HVNI) and Noninvasive Positive Pressure Ventilation (NIPPV)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 7 sitesUnited States
Study dates: 11 Nov 2020to 22 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

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

Other trials in United States

About this study

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

Read the 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.

Conditions: Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Dyspnea, Hypercapnic Acidosis
Being tested: High Velocity Nasal Insufflation (HVNI), Noninvasive Positive Pressure Ventilation (NIPPV)
Medical subject headings: Respiratory Insufficiency, Pulmonary Disease, Chronic Obstructive, Dyspnea, Acidosis, Respiratory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High Velocity Nasal Insufflation (HVNI)Device
Also called Vapotherm Precision Flow Plus
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
Also called Philips Respironics V60
The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.

Study groups in NCT04709562
Study group	Role	What they receive
High Velocity Nasal Insufflation (HVNI)	Experimental	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. Receives: Device: High Velocity Nasal Insufflation (HVNI)
Noninvasive Positive Pressure Ventilation (NIPPV)	Active comparator	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. Receives: Device: Noninvasive Positive Pressure Ventilation (NIPPV)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (13)

Patient Vital Signs - Heart Rate [HR]
Heart rate, measured in beats per minute (bpm)
Measured: 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)
Measured: 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 (%)
Measured: 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.
Measured: 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.
Measured: 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
Partial pressure of CO2 (PCO2), measured in mmHg
Measured: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Patient Basic Metabolic Panel - Sodium
Sodium [Na+], measured in mEq/L
Measured: Baseline, at study start only
Patient Basic Metabolic Panel - Potassium
Potassium [K+], measured in mEq/L
Measured: Baseline, at study start only
Patient Basic Metabolic Panel - Chloride
Chloride [Cl-], measured in mEq/L
Measured: Baseline, at study start only
Patient Basic Metabolic Panel - Lactate
Lactate, measured in mEq/L
Measured: Baseline, at study start only
Patient Basic Metabolic Panel - Glucose
Glucose, measured in mg/dL
Measured: Baseline, at study start only
Patient Base Excess - Base Excess
Base Excess, measured in mEq/L
Measured: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Patient Bicarbonate - Bicarbonate
Bicarbonate, measured in mEq/L
Measured: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Nov 202022 Jun 2023

First posted14 Jan 2021
Study start11 Nov 2020
Primary completion26 May 2023
Study completion22 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04709562
Sponsor's protocol ID: RP-VTPF2020001Sci
Acronym: HYPERACT
Status last verified: Aug 2024
First submitted: 7 Jan 2021
Last updated: 9 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Recruiting
Role of HFNC During FOB in Patients With Respiratory Failure
Respiratory Failure, Respiratory Failure With Hypercapnia
RecruitingObservational study
RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV
Pulmonary Disease, Chronic Obstructive (COPD), Chronic Respiratory Failure With Hypercapnia

All Hypercapnic Respiratory Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hypercapnia Clinical Efficacy by NIPPV v HVNI: A Randomized Control Trial in the Stabilization of Acute Hypercarbic Respiratory Failure
ClinicalTrials.gov ID: NCT04709562
Acronym / sponsor ID: HYPERACT / RP-VTPF2020001Sci
Conditions: Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Dyspnea, Hypercapnic Acidosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Vapotherm, Inc.Industry (pharma, biotech, devices)
Collaborators: Erlanger Baroness Hospital, Cooper Norcross Health, Dignity Health Medical Foundation, George Washington University, Madigan Army Medical Center, Valley Presbyterian Hospital, University of Maryland
Study start: 11 Nov 2020 (actual)
Primary completion: 26 May 2023 (actual)
Study completion: 22 Jun 2023 (actual)
First posted: 14 Jan 2021 (actual)
Results: Posted 9 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
High Velocity Nasal Insufflation (HVNI)	Experimental	Device: 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.
Noninvasive Positive Pressure Ventilation (NIPPV)	Active comparator	Device: 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High Velocity Nasal Insufflation (HVNI)Also: Vapotherm Precision Flow PlusThe purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.	Device	High Velocity Nasal Insufflation (HVNI)
Noninvasive Positive Pressure Ventilation (NIPPV)Also: Philips Respironics V60The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.	Device	Noninvasive Positive Pressure Ventilation (NIPPV)

Primary outcome

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.

13 secondary outcomes

Patient Vital Signs - Heart Rate [HR]
Time frame: 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
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
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 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
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
Patient Basic Metabolic Panel - Sodium
Time frame: Baseline, at study start only
Patient Basic Metabolic Panel - Potassium
Time frame: Baseline, at study start only
Patient Basic Metabolic Panel - Chloride
Time frame: Baseline, at study start only
Patient Basic Metabolic Panel - Lactate
Time frame: Baseline, at study start only
Patient Basic Metabolic Panel - Glucose
Time frame: Baseline, at study start only
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
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

Results and safety

Results posted to the registry on 9 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Velocity Nasal Insufflation (HVNI)	36	36
Noninvasive Positive Pressure Ventilation (NIPPV)	32	32

Primary outcome: 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. Mean (Standard Deviation). Unit: units on a scale (0-10)

Measure	High Velocity Nasal Insufflation (HVNI) n = 36	Noninvasive Positive Pressure Ventilation (NIPPV) n = 32
Baseline	5.4 (2.93)	5.6 (2.41)
30 Min	3.97 (2.82)	4.54 (1.65)
60 Min	3.09 (2.70)	4.07 (1.77)
240 Min	3.17 (2.59)	3.34 (2.04)

Population analysed: The participants had to have an RPD reading at all four time points.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Over the course of the study, which took place for a total of 4 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Velocity Nasal Insufflation (HVNI)	0 of 36 (0%)	0 of 36 (0%)	0 of 36
Noninvasive Positive Pressure Ventilation (NIPPV)	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypercapnic Respiratory Failure

Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Recruiting
Role of HFNC During FOB in Patients With Respiratory Failure
Respiratory Failure, Respiratory Failure With Hypercapnia
RecruitingObservational study
RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV
Pulmonary Disease, Chronic Obstructive (COPD), Chronic Respiratory Failure With Hypercapnia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Meltzer, MD, MS principal investigator

George Washington University

Christopher W Jones, MD principal investigator

Cooper Norcross Health

Anthony Innabi, MBA, RRT-NPS principal investigator

Dignity Health Medical Foundation

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04709562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.