Clinical Stabilization of Hypercapnia: NIPPV v HVNI

NCT04709562 | Completed Results FDA Device

• 1 other identifier: RP-VTPF2020001Sci
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 7

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 \[NIPPV\].

Conditions

Hypercapnic Respiratory Failure; Chronic Obstructive Pulmonary Disease; Dyspnea; Hypercapnic Acidosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• Patient Vital Signs - Heart Rate [HR]

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

• Patient Vital Signs - Respiratory Rate [RR]

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

• Patient Vital Signs - Oxygen Saturation [SpO2]

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

• Patient Communication Capability - Patient Stability Index

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

• Patient Venous Blood Gas - pH

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

Other Outcomes (5)

• Patient Perception Score - Relief of Symptoms

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

• Patient Perception Score - Comfort/Tolerance

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

• Clinician Perception Score - Expected/Perceived Outcomes

  At study end, 4 hours from study start

Study Arms (2)

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)

Interventions

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.

Also known as: Vapotherm Precision Flow Plus

High Velocity Nasal Insufflation (HVNI)

Noninvasive Positive Pressure Ventilation (NIPPV) DEVICE

The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.

Also known as: Philips Respironics V60

Noninvasive Positive Pressure Ventilation (NIPPV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vapotherm, Inc.: lead
• Erlanger Baroness Hospital: collaborator
• The Cooper Health System: collaborator
• Dignity Health Medical Foundation: collaborator
• George Washington University: collaborator
• Madigan Army Medical Center: collaborator
• Valley Presbyterian Hospital: collaborator
• University of Maryland: collaborator

Study Sites (7)

Valley Presbyterian Hospital

Los Angeles, California, 91405, United States

Location

Dignity Health - St. John's Regional Medical Center

Oxnard, California, 93030, United States

Location

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Erlanger Health System

Chattanooga, Tennessee, 37403, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Pulmonary Disease, Chronic Obstructive; Dyspnea; Acidosis, Respiratory

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Kathy Gerich
• Organization: Vapotherm Inc

kgerich@vtherm.com

(585) 469-6753

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 14, 2021
• Study Start: November 11, 2020
• Primary Completion: May 26, 2023
• Study Completion: June 22, 2023
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-08

Locations

US (7)