Clinical Stabilization of Hypercapnia: NIPPV v HVNI

Completed · Not applicable

Conditions studied: Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Dyspnea, Hypercapnic Acidosis

In brief

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 \[NIPPV\].

Key facts

Study ID

NCT04709562

Run by

Vapotherm, Inc.

People needed

68

Starts

2020-11-11

Expected to finish

2023-06-22

Last updated by the study team

2024-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Valley Presbyterian Hospital — Los Angeles, California, United States
• Dignity Health - St. John's Regional Medical Center — Oxnard, California, United States
• George Washington University Hospital — Washington D.C., District of Columbia, United States
• University of Maryland — Baltimore, Maryland, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Erlanger Health System — Chattanooga, Tennessee, United States
• Madigan Army Medical Center — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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