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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04709562
Other study ID # RP-VTPF2020001Sci
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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