Clinical Stabilization of Hypercapnia: NIPPV v HVNI

Chronic Obstructive Pulmonary Disease Clinical Trial

— HYPERACT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04709562
• Other study ID #: RP-VTPF2020001Sci
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 11, 2020
• Est. completion date: December 22, 2023

Study information

• Verified date: June 2023
• Source: Vapotherm, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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].

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 73
• Est. completion date: December 22, 2023
• Est. primary completion date: May 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Chronic Obstructive Pulmonary Disease
• Dyspnea
• Hypercapnia
• Hypercapnic Acidosis
• Hypercapnic Respiratory Failure
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Cooper University Hospital	Camden	New Jersey
United States	Erlanger Health System	Chattanooga	Tennessee
United States	Valley Presbyterian Hospital	Los Angeles	California
United States	Dignity Health - St. John's Regional Medical Center	Oxnard	California
United States	Madigan Army Medical Center	Tacoma	Washington
United States	George Washington University Hospital	Washington	District of Columbia

Sponsors (8)

Lead Sponsor	Collaborator
Vapotherm, Inc.	Dignity Health - St. John's Regional Medical Center, Erlanger Baroness Hospital, George Washington University, Madigan Army Medical Center, The Cooper Health System, University of Maryland, Valley Presbyterian Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	Patient Vital Signs - Heart Rate [HR]	Heart rate, measured in beats per minute (bpm)	Through study completion, an average of 4 hours
Secondary	Patient Vital Signs - Respiratory Rate [RR]	Respiratory rate, measured in breaths per minute (brpm)	Through study completion, an average of 4 hours
Secondary	Patient Vital Signs - Oxygen Saturation [SpO2]	SpO2 measured as percentage of oxygen saturation (%)	Through study completion, an average of 4 hours
Secondary	Patient Vital Signs - Blood Pressure [BP]	Blood pressure, measured in mmHg	Through study completion, an average of 4 hours
Secondary	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
Secondary	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
Secondary	Patient Venous Blood Gas - Venous PCO2	Partial pressure of CO2 (PCO2), measured in mmHg	Through study completion, an average of 4 hours
Secondary	Patient Venous Blood Gas - Venous PO2	Partial pressure of venous oxygen (PO2), measured in mmHg	Through study completion, an average of 4 hours
Secondary	Patient Basic Metabolic Panel - Sodium	Sodium [Na+], measured in mEq/L	Baseline, at study start only
Secondary	Patient Basic Metabolic Panel - Potassium	Potassium [K+], measured in mEq/L	Baseline, at study start only
Secondary	Patient Basic Metabolic Panel - Chloride	Chloride [Cl-], measured in mEq/L	Baseline, at study start only
Secondary	Patient Basic Metabolic Panel - Lactate	Lactate, measured in mEq/L	Baseline, at study start only
Secondary	Patient Basic Metabolic Panel - Glucose	Glucose, measured in mg/dL	Baseline, at study start only
Secondary	Patient Base Excess - Base Excess	Base Excess, measured in mEq/L	Through study completion, an average of 4 hours
Secondary	Patient Bicarbonate - Bicarbonate	Bicarbonate, measured in mEq/L	Through study completion, an average of 4 hours