NCT04709562

Clinical Stabilization of Hypercapnia: NIPPV v HVNI

Hypercapnia Clinical Efficacy by NIPPV v HVNI: A Randomized Control Trial in the Stabilization of Acute Hypercarbic Respiratory Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Vapotherm, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 \[NIPPV\].

Detailed description

The overall objective of this randomized study is to evaluate the efficacy of HVNI, in comparison to NIPPV, to clinically stabilize and provide respiratory therapy to patients who have COPD with moderate-to-severe hypercapnic respiratory distress upon presentation. It is hypothesized that HVNI is comparable to NIPPV in the stabilization and relief of moderate-to-severe hypercapnic respiratory distress upon presentation, by relieving the patient's dyspnea (breathlessness) within 4 hours to a comparable degree to NIPPV.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-11
• Primary completion: 2023-05-26
• Completion: 2023-06-22
• First posted: 2021-01-14
• Last updated: 2024-08-09
• Results posted: 2024-08-09

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study