Clinical Stabilization of Hypercapnia: NIPPV v HVNI

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

Interventions

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.

DEVICE

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.

Sponsors & Collaborators

• Erlanger Baroness Hospital

  collaborator OTHER_GOV

• The Cooper Health System

  collaborator OTHER

• Dignity Health Medical Foundation

  collaborator OTHER

• George Washington University

  collaborator OTHER

• Madigan Army Medical Center

  collaborator FED

• Valley Presbyterian Hospital

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• Vapotherm, Inc.

  lead INDUSTRY

Principal Investigators

• Andrew Meltzer, MD, MS · George Washington University

• Christopher W Jones, MD · The Cooper Health System

• Anthony Innabi, MBA, RRT-NPS · Dignity Health Medical Foundation

• Joshua Oliver, MD · Madigan Army Medical Hospital

• Cynthia Pfeiffer, MD · Valley Presbyterian Hospital

• Richard Wilkerson, MD · University of Maryland

• David Yamane, MD · George Washington University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-11-11

Primary Completion

2023-05-26

Completion

2023-06-22

FDA Device

Yes

Countries

• United States

Study Locations