Clinical trial NCT04709562: Clinical Stabilization of Hypercapnia: NIPPV v HVNI
Official title: Hypercapnia Clinical Efficacy by NIPPV v HVNI: A Randomized Control Trial in the Stabilization of Acute Hypercarbic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercapnic Respiratory Failure
Chronic Obstructive Pulmonary Disease
Dyspnea
Hypercapnic Acidosis
Lead sponsor: Vapotherm, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Erlanger Baroness Hospital
name: The Cooper Health System
name: Dignity Health Medical Foundation
name: George Washington University
name: Madigan Army Medical Center
name: Valley Presbyterian Hospital
name: University of Maryland
First posted: 2021-01-14
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 \[NIPPV\].

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rated Perceived Dyspnea [RPD]
timeFrame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Secondary outcomes:
measure: Patient Vital Signs - Heart Rate [HR]
timeFrame: During four time points in the study; Baseline, 30 min, 60 min, and 240 min
measure: Patient Vital Signs - Respiratory Rate [RR]
timeFrame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
measure: Patient Vital Signs - Oxygen Saturation [SpO2]
timeFrame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
measure: Patient Communication Capability - Patient Stability Index
timeFrame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
measure: Patient Venous Blood Gas - pH
timeFrame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
measure: Patient Venous Blood Gas - Venous PCO2
timeFrame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
measure: Patient Basic Metabolic Panel - Sodium
timeFrame: Baseline, at study start only
measure: Patient Basic Metabolic Panel - Potassium
timeFrame: Baseline, at study start only
measure: Patient Basic Metabolic Panel - Chloride
timeFrame: Baseline, at study start only
measure: Patient Basic Metabolic Panel - Lactate
timeFrame: Baseline, at study start only
measure: Patient Basic Metabolic Panel - Glucose
timeFrame: Baseline, at study start only
measure: Patient Base Excess - Base Excess
timeFrame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
measure: Patient Bicarbonate - Bicarbonate
timeFrame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Other outcomes:
measure: Patient Perception Score - Relief of Symptoms
timeFrame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
measure: Patient Perception Score - Comfort/Tolerance
timeFrame: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
measure: Clinician Perception Score - Expected/Perceived Outcomes
timeFrame: At study end, 4 hours from study start
measure: Clinician Perception Score - Patient Comfort/Tolerance
timeFrame: At study end, 4 hours from study start
measure: Clinician Perception Score - Ease of Use
timeFrame: At study end, 4 hours from study start
Locations:
city: Los Angeles
country: United States
facility: Valley Presbyterian Hospital
state: California
city: Oxnard
country: United States
facility: Dignity Health - St. John's Regional Medical Center
state: California
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: George Washington University
name: Andrew Meltzer, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cooper Health System
name: Christopher W Jones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dignity Health Medical Foundation
name: Anthony Innabi, MBA, RRT-NPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Madigan Army Medical Hospital
name: Joshua Oliver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Valley Presbyterian Hospital
name: Cynthia Pfeiffer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Richard Wilkerson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University
name: David Yamane, MD
role: PRINCIPAL_INVESTIGATOR
References: