Tolerance and Acute Effects of a New HFNT Nasal Cannula

NCT05182294 | Completed FDA Device

• 1 other identifier: 1319877
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hypercapnia (PaCO2 ≥ 45 mm Hg)

Outcome Measures

Primary Outcomes (2)

• Determining the level of comfort experienced by the patient of using high-flow nasal oxygen administered by two different nasal cannulas.

  This is a pilot study in which the primary outcome is to determine the level of comfort experienced by the patient of using high-flow nasal oxygen administered by two different nasal cannulas. The level of comfort will be assessed by a 100 mm visual analog scale from 0 (no discomfort) to 100 (maximal imaginable discomfort)

  6 hours

• Sensation of shortness of breath

  Likert scale model indicating marked improvement (+2), slight improvement (+1), no change (0), slight deterioration (-1) and marked deterioration (-2) in patient's sensation of shortness of breath and overall comfort

  6 hours

Study Arms (2)

Conventional symmetric nasal cannula

ACTIVE COMPARATOR

The patient's breathing pattern will be assessed by inductive plethysmography while using the cannula and receive HFNT for 2 hours during the first session. Patients will then be randomized to use of the conventional symmetric nasal cannula or the new asymmetric nasal cannula. At the end of the first session questionnaire data will be collected and ABGs will be repeated followed by a 30-minute rest period without any device. Patients will then crossover to receive HFNT via the other cannula type for another 2 hours during the second session. Inductive plethysmography will again be worn and ABGs will be obtained, and questionnaires will again be administered

Device: AIRVO 2, the new asymmetric nasal cannula

AIRVO 2; new asymmetric nasal cannula

ACTIVE COMPARATOR

The patient's breathing pattern will be assessed by inductive plethysmography while using the cannula and receive HFNT for 2 hours during the first session. Patients will then be randomized to use of the conventional symmetric nasal cannula or the new asymmetric nasal cannula. At the end of the first session questionnaire data will be collected and ABGs will be repeated followed by a 30-minute rest period without any device. Patients will then crossover to receive HFNT via the other cannula type for another 2 hours during the second session. Inductive plethysmography will again be worn and ABGs will be obtained, and questionnaires will again be administered

Device: AIRVO 2, the new asymmetric nasal cannula

Interventions

AIRVO 2, the new asymmetric nasal cannula DEVICE

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..

Also known as: Conventional asymmetric nasal cannula

AIRVO 2; new asymmetric nasal cannula; Conventional symmetric nasal cannula

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• i.aged ≥ 40 years (ii) hospitalization for acute exacerbation of COPD; (iii) smoker or ex-smoker (iv) FEV1 \<80% of predicted and FEV1/FVC \<70% postbronchodilator within 12 months prior to admission (v) have no other lung disease (including asthma) as a principal cause of pulmonary function limitation (vi) baseline PaCO2 ≥ 45 mm Hg at study entry. (vii) willing to give informed consent (viii) willing to participate in measurement of ABGs (ix) will to provide a brief history and physical examination and answer questionnaires.

You may not qualify if:

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Women who are known to be pregnant at the time of hospital admission
• Prisoners
• Individuals who do not understand English

Sponsors & Collaborators

• Temple University: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Hypercapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerard J Criner, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to use of the conventional symmetric nasal cannula or the new asymmetric nasal cannula and receive HFNT for 2 hours during the first session. At the end of the first session questionnaire data will be collected and ABGs will be repeated followed by a 30-minute rest period without any device. Patients will then crossover to receive HFNT via the other cannula type for another 2 hours during the second session.Inductive plethysmography will again be worn and ABGs will be obtained, and questionnaires will again be administered. At the end of this second session the patient will be discharged from the study and receive usual medical care for the COPD exacerbation and other medical conditions as clinically indicated.

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 10, 2022
• Study Start: May 25, 2022
• Primary Completion: December 14, 2022
• Study Completion: January 31, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)