Clinical Stabilization of Hypercapnia: NIPPV v HVNI | NCT04709562

Name	Class
Erlanger Baroness Hospital	OTHER_GOV
The Cooper Health System	OTHER
Dignity Health Medical Foundation	OTHER
George Washington University

Label	Type	Description	Intervention Names
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.	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.	Device: Noninvasive Positive Pressure Ventilation (NIPPV)

Name	Type	Description	Arm Group Labels	Other Names
High Velocity Nasal Insufflation (HVNI)	Device	The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.

Measure	Description	Time Frame
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.	During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

Measure	Description	Time Frame
Patient Vital Signs - Heart Rate [HR]	Heart rate, measured in beats per minute (bpm)	During four time points in the study; Baseline, 30 min, 60 min, and 240 min
Patient Vital Signs - Respiratory Rate [RR]

Measure	Description	Time Frame
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.	During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

Name	Affiliation	Role
Andrew Meltzer, MD, MS	George Washington University	Principal Investigator
Christopher W Jones, MD	The Cooper Health System	Principal Investigator
Anthony Innabi, MBA, RRT-NPS	Dignity Health Medical Foundation	Principal Investigator
Joshua Oliver, MD	Madigan Army Medical Hospital	Principal Investigator
Cynthia Pfeiffer, MD	Valley Presbyterian Hospital	Principal Investigator
Richard Wilkerson, MD	University of Maryland	Principal Investigator
David Yamane, MD	George Washington University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Valley Presbyterian Hospital		Los Angeles	California	91405	United States
Dignity Health - St. John's Regional Medical Center

ID	Title	Description
FG000	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. 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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 23, 2020

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

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

Posted

Mean

Standard Deviation

units on a scale (0-10)

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

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants	OG00036 OG00132

Title

Denominators

Categories

Baseline

- ParticipantsOG00036
- ParticipantsOG00132

Title	Measurements
	OG0005.4± 2.93

Secondary

Patient Vital Signs - Heart Rate [HR]

Heart rate, measured in beats per minute (bpm)

Patients who had their Heart Rate collected during the four time points in the study.

Posted

Mean

Standard Deviation

BPM

During four time points in the study; Baseline, 30 min, 60 min, and 240 min

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Secondary

Patient Vital Signs - Respiratory Rate [RR]

Respiratory rate, measured in breaths per minute (brpm)

Patients who had their Respiratory Rate collected during the four different timepoints in the study.

Posted

Mean

Standard Deviation

Breaths per min

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

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Secondary

Patient Vital Signs - Oxygen Saturation [SpO2]

SpO2 measured as percentage of oxygen saturation (%)

Patients who had their SPO2 collected during the four timepoints in the study.

Posted

Mean

Standard Deviation

percentage of oxygen saturation

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

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Secondary

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.

Patients that had the Stability Index collected during the four time points in the study.

Posted

Mean

Standard Deviation

units on a scale (0-100)

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

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Secondary

Patient Venous Blood Gas - pH

pH, measured as units on a pH scale from 0 - 14. Neutral scores indicate a better outcome.

Patients that had this lab value collected during the four time points in the study.

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Secondary

Patient Venous Blood Gas - Venous PCO2

Partial pressure of CO2 (PCO2), measured in mmHg

Patients that had PCO2 collected during the four time points during the study.

Posted

Mean

Standard Deviation

mmHg

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

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Secondary

Patient Basic Metabolic Panel - Sodium

Sodium [Na+], measured in mEq/L

Posted

Mean

Standard Deviation

mEq/L

Baseline, at study start only

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants

Secondary

Patient Basic Metabolic Panel - Potassium

Potassium [K+], measured in mEq/L

Posted

Mean

Standard Deviation

mEq/L

Baseline, at study start only

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants

Secondary

Patient Basic Metabolic Panel - Chloride

Chloride [Cl-], measured in mEq/L

Posted

Mean

Standard Deviation

mEq/L

Baseline, at study start only

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants

Secondary

Patient Basic Metabolic Panel - Lactate

Lactate, measured in mEq/L

Posted

Mean

Standard Deviation

mEq/L

Baseline, at study start only

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants

Secondary

Patient Basic Metabolic Panel - Glucose

Glucose, measured in mg/dL

Posted

Mean

Standard Deviation

mg/dL

Baseline, at study start only

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants

Secondary

Patient Base Excess - Base Excess

Base Excess, measured in mEq/L

Patients that had this lab value collected at the timepoints during the study.

Posted

Mean

Standard Deviation

mEq/L

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

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Secondary

Patient Bicarbonate - Bicarbonate

Bicarbonate, measured in mEq/L

Patients that had this lab value collected during the four time points in the study.

Posted

Mean

Standard Deviation

mEq/L

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

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Other Pre-specified

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.

Patients that had this data collected at the four time points during the study.

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Other Pre-specified

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.

Patients who had their score collected during the four different timepoints in the study.

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Other Pre-specified

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.

Posted

Mean

Standard Deviation

units on a scale

At study end, 4 hours from study start

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Other Pre-specified

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.

Posted

Mean

Standard Deviation

units on a scale

At study end, 4 hours from study start

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Other Pre-specified

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.

Posted

Mean

Standard Deviation

units on a scale

At study end, 4 hours from study start

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

ID	Term
D012131	Respiratory Insufficiency
D029424	Pulmonary Disease, Chronic Obstructive
D004417	Dyspnea
D000142	Acidosis, Respiratory

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D000138	Acidosis
D000137	Acid-Base Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Title	Description
BG000	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. 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.
BG001	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. 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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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. 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.	0	36	0	36	0	36
EG001	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. 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.	0	32	0	32	0	32