Home High-Flow Nasal Cannula vs. Noninvasive Ventilation for Stable Chronic Respiratory Failure

NCT06872801 | Not Yet Recruiting FDA Device

• 1 other identifier: WonjuSCH-SHK001-V1.0
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the effects of home high-flow nasal cannula (HFNC) therapy and noninvasive ventilation (NIV) in patients with stable chronic hypercapnic respiratory failure. The main questions it aims to answer are:

• Does HFNC or NIV reduce blood carbon dioxide levels more effectively?
• How well do patients tolerate and adhere to each therapy?
• Are there differences in oxygen saturation, respiratory rate, and quality of life between the two treatments? Participants Will:
• Use either HFNC (myAirvo2®) or NIV (Trilogy Evo®) every night for at least 4 hours over a 6-week period.
• Visit the hospital for checkups and arterial blood gas tests at the end of each 6-week period.
• Switch to the alternate device after six weeks as part of the crossover study design.
• Have their device usage recorded and analyzed.

Conditions

Stable Chronic Hypercapnic Respiratory Failure

Keywords

Chronic Hypercapnic Respiratory Failure; Noninvasive Ventilation; High-Flow Nasal Cannula; Randomized Controlled Trial; Crossover Design

Outcome Measures

Primary Outcomes (1)

• PaCO2

  Arterial blood gas analysis will be performed three times to assess the improvement of hypercapnia, the primary outcome, by measuring pH, PaCO₂, PaO₂, HCO₃-, and SpO₂.

  The first measurement will be conducted at baseline, on the day the first device is applied. The second measurement will be taken at week 6 from baseline, after the device has been used for six weeks. The final measurement will be performed at week 12 fr

Secondary Outcomes (2)

• TCO2

  The first measurement will be conducted at baseline, on the day the first device is applied. The second measurement will be taken at week 6 from baseline, after the device has been applied for six weeks. The final measurement will be performed at week 12

• Compliance

  The first assessment will be conducted at week 6 from baseline, after the first device has been applied for six weeks. The second assessment will be performed at week 12 from baseline, after the second device has been applied for six weeks.

Study Arms (2)

HFNC-NIV

EXPERIMENTAL

Participants first use HFNC for six weeks, then switch to NIV for six weeks

Device: High-Flow Nasal Cannula; Device: Noninvasive Ventilation

NIV-HFNC

EXPERIMENTAL

Participants first use NIV for six weeks, then switch to HFNC for six weeks

Device: High-Flow Nasal Cannula; Device: Noninvasive Ventilation

Interventions

High-Flow Nasal Cannula DEVICE

To compare the effects of NIV (Trilogy Evo®) and HFNC (myAirvo2®) in patients with chronic hypercapnic COPD.

HFNC-NIV; NIV-HFNC

Noninvasive Ventilation DEVICE

to compare the effects of NIV (Trilogy Evo®) and HFNC (myAirvo2®) in patients with chronic hypercapnic COPD

HFNC-NIV; NIV-HFNC

Eligibility Criteria

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

You may qualify if:

• Adult aged 40 years or older
• Diagnosed with COPD
• Arterial blood gas test, pCO2 \> 45 mmHg at stable status
• A person who can read or write in Korean
• Written informed consent to participate in this study

You may not qualify if:

• A person who disagrees with the content of a informed consent
• Those who have difficulty wearing NIV or HFNC
• Cognitive impairment or apsychiatric disorder
• Hypoxic or hypercapnic exacerbation within the previous four weeks

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwondo, 26426, South Korea

Location

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Sang-Ha Kim

CONTACT

82-33-741-0926; sanghakim@yonsei.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 12, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)