CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 68 enrolled
Drug / intervention
High Velocity Nasal Insufflation (HVNI) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04709562
NCT04709562N/ACompleted
CompareCT.gov

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

Vapotherm, Inc.·interventional·Posted Jan 14, 2021·Updated Aug 9, 2024

In Brief

A clinical study evaluating High Velocity Nasal Insufflation (HVNI) and Noninvasive Positive Pressure Ventilation (NIPPV) for Hypercapnic Respiratory Failure and 3 related conditions. Completed, enrolled 68 participants across 7 sites.

Detailed 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 \[NIPPV\].

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Dyspnea, Hypercapnic Acidosis
CountriesUnited States
CollaboratorsErlanger Baroness Hospital, The Cooper Health System, Dignity Health Medical Foundation, George Washington University, Madigan Army Medical Center, Valley Presbyterian Hospital, University of Maryland

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJan 14, 2021
Enrollment StartNov 11, 2020
Primary CompletionMay 26, 2023
Study CompletionJun 22, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 5.5 years ago

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.

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.