Hypercapnia Clinical Efficacy by NIPPV v HVNI: A Randomized Control Trial in the Stabilization of Acute Hypercarbic Respiratory Failure
Status: Completed
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 \[NIPPV\].
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
United States
California
Valley Presbyterian Hospital
Los Angeles
Dignity Health - St. John's Regional Medical Center
Oxnard
Washington, D.c.
George Washington University Hospital
Washington D.c.
Maryland
University of Maryland
Baltimore
New Jersey
Cooper University Hospital
Camden
Tennessee
Erlanger Health System
Chattanooga
Washington
Madigan Army Medical Center
Tacoma
Time Frame
Start Date: 2020-11-11
Completion Date: 2023-06-22
Participants
Target number of participants: 68
Treatments
Experimental: 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.
Active_comparator: 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.
Authors
Christopher W Jones
Related Therapeutic Areas
Sponsors
Collaborators: Valley Presbyterian Hospital, Erlanger Baroness Hospital, Dignity Health Medical Foundation, University of Maryland, Madigan Army Medical Center, George Washington University, The Cooper Health System
Leads: Vapotherm, Inc.