Clinical Stabilization of Hypercapnia: NIPPV v HVNI (HYPERACT)

Vapotherm

Status: Completed

Conditions: Dyspnea; Hypercapnic Acidosis; Chronic Obstructive Pulmonary Disease; Hypercapnic Respiratory Failure

Treatments: Device: High Velocity Nasal Insufflation (HVNI); Device: Noninvasive Positive Pressure Ventilation (NIPPV)

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT04709562

RP-VTPF2020001Sci

Details and patient eligibility

About

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].

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

High Velocity Nasal Insufflation (HVNI)

Experimental group

Description:

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.

Treatment:

Device: High Velocity Nasal Insufflation (HVNI)

Noninvasive Positive Pressure Ventilation (NIPPV)

Active Comparator group

Description:

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.

Treatment:

Device: Noninvasive Positive Pressure Ventilation (NIPPV)