N/A
N=68
Clinical Stabilization of Hypercapnia: NIPPV v HVNI
Hypercapnic Respiratory Failure · Chronic Obstructive Pulmonary Disease · Dyspnea · Hypercapnic Acidosis
Bottom Line
View on ClinicalTrials.gov: NCT04709562 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Rated Perceived Dyspnea [RPD] — 5.4; 5.6; 3.97; 4.54 units on a scale (0-10)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High Velocity Nasal Insufflation (HVNI) (Device); Noninvasive Positive Pressure Ventilation (NIPPV) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vapotherm, Inc.
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rated Perceived Dyspnea [RPD] |
5.4; 5.6; 3.97; 4.54; 3.09; 4.07 | — |
| SECONDARY Patient Vital Signs - Heart Rate [HR] |
93.2; 85.9; 90.78; 87.24; 90.03; 84.04 | — |
| SECONDARY Patient Vital Signs - Respiratory Rate [RR] |
20.9; 21.2; 21.13; 22.12; 20.56; 21.32 | — |
| SECONDARY Patient Vital Signs - Oxygen Saturation [SpO2] |
94.4; 96.8; 95.69; 96.80; 95.78; 97.28 | — |
| SECONDARY Patient Communication Capability - Patient Stability Index |
62.00; 62.50; 73.81; 68.92; 77.75; 76.48 | — |
| SECONDARY Patient Venous Blood Gas - pH |
7.27; 7.27; 7.3; 7.28; 7.31; 7.3 | — |
| SECONDARY Patient Venous Blood Gas - Venous PCO2 |
77.8; 76.5; 72.56; 73.22; 71.19; 70.95 | — |
| SECONDARY Patient Basic Metabolic Panel - Sodium |
139.9; 140.4 | — |
| SECONDARY Patient Basic Metabolic Panel - Potassium |
4.4; 4.4 | — |
| SECONDARY Patient Basic Metabolic Panel - Chloride |
97.7; 99.9 | — |
| SECONDARY Patient Basic Metabolic Panel - Lactate |
1.6; 1.2 | — |
| SECONDARY Patient Basic Metabolic Panel - Glucose |
133.8; 137.2 | — |
| SECONDARY Patient Base Excess - Base Excess |
6.7; 7.7; 7.43; 7.74; 6.71; 7.48 | — |
| SECONDARY Patient Bicarbonate - Bicarbonate |
32.0; 33.8; 33.18; 32.43; 32.75; 32.45 | — |
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 Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04709562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.