Clinical Stabilization of Hypercapnia: NIPPV v HVNI

NCT ID: NCT04709562

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-11
• Study Completion Date: 2023-06-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

High Velocity Nasal Insufflation (HVNI)

Intervention Type: 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)

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.

Group Type: ACTIVE_COMPARATOR

Noninvasive Positive Pressure Ventilation (NIPPV)

Intervention Type: DEVICE

The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Vapotherm Precision Flow Plus; Philips Respironics V60

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erlanger Baroness Hospital

OTHER_GOV

Sponsor Role: collaborator

The Cooper Health System

OTHER

Sponsor Role: collaborator

Dignity Health Medical Foundation

OTHER

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: collaborator

Madigan Army Medical Center

FED

Sponsor Role: collaborator

Valley Presbyterian Hospital

OTHER

Sponsor Role: collaborator

University of Maryland

OTHER

Sponsor Role: collaborator

Vapotherm, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Meltzer, MD, MS

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Christopher W Jones, MD

Role: PRINCIPAL_INVESTIGATOR

The Cooper Health System

Anthony Innabi, MBA, RRT-NPS

Role: PRINCIPAL_INVESTIGATOR

Dignity Health Medical Foundation

Joshua Oliver, MD

Role: PRINCIPAL_INVESTIGATOR

Madigan Army Medical Hospital

Cynthia Pfeiffer, MD

Role: PRINCIPAL_INVESTIGATOR

Valley Presbyterian Hospital

Richard Wilkerson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

David Yamane, MD

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Locations

Valley Presbyterian Hospital

Los Angeles, California, United States

Dignity Health - St. John's Regional Medical Center

Oxnard, California, United States

George Washington University Hospital

Washington D.C., District of Columbia, United States

University of Maryland

Baltimore, Maryland, United States

Cooper University Hospital

Camden, New Jersey, United States

Erlanger Health System

Chattanooga, Tennessee, United States

Madigan Army Medical Center

Tacoma, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RP-VTPF2020001Sci

Identifier Type: -

Identifier Source: org_study_id