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Tolerance and Acute Effects of a New HFNT Nasal Cannula

NCT05182294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-04-06

No results posted yet for this study

Summary

In the care of patients experiencing an acute exacerbation of COPD, supplemental oxygen therapy is often required. Oxygen is typically administered at flow rates between 1 and 4 liters per minute. High-flow nasal therapy (HFNT) has been reported to have beneficial effects in patients with hypoxemic respiratory failure and in hospitalized and non-hospitalized patients with severe COPD. Clinical efficacy in improving gas exchange depends upon patient tolerance and device-related properties such as flow rate and creation of turbulent flow in the conducting airways to improve oxygenation and carbon dioxide elimination. Alterations of nasal prong structure, such as nasal prong dimensions, may produce more robust turbulent flow at lower flow rates thereby improving gas exchange as well as patient tolerance. In this pilot study we will assess the impact of a new nasal cannula with asymmetric cannula dimensions that may create more turbulent flow at lower flow rates compared to the current symmetric nasal cannula on patient comfort as well as vital signs, pulse oximetry, breathing pattern and parameters of gas exchange in hospitalized patients with a COPD exacerbation.

Conditions

  • COPD Exacerbation Acute

Interventions

DEVICE

AIRVO 2, the new asymmetric nasal cannula

The AIRVO 2 is a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patient through a variety of patient interfaces. This is an FDA-approved 510k device for use in hospitals and nursing homes. During HFNT, oxygen will be passed through a heated humidifier (AIRVO 2, Fisher and Paykel Healthcare) and applied continuously through conventional large-bore binasal symmetric prongs or the new asymmetric prongs cannula device, with a gas flow rate of 20-35 liters per minute or as high as the patient will tolerate and an FiO2 to keep SaO2 ≥ 90% (Airvo 2, Fisher and Paykel Healthcare). Gas flow temperature will be adjusted based on patient's comfort and range from 34-37 degrees centigrade. After completion of the study, patients will be switched back to oxygen therapy administered by nasal prongs or mask..

Sponsors & Collaborators

  • Fisher and Paykel Healthcare

    collaborator INDUSTRY

  • Temple University

    lead OTHER

Principal Investigators

  • Gerard J Criner, MD · Temple University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2022-12-14
Completion
2023-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05182294 on ClinicalTrials.gov