Chronic Obstructive Pulmonary Disease Clinical Trial
— HYPERACTOfficial title:
Hypercapnia Clinical Efficacy by NIPPV v HVNI: A Randomized Control Trial in the Stabilization of Acute Hypercarbic Respiratory Failure
Verified date | June 2023 |
Source | Vapotherm, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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].
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 |
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 |
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 |
United States,
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 |
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