Home High-Flow Nasal Cannula vs. Noninvasive Ventilation for Stable Chronic Respiratory Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorWonju Severance Christian Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
High-Flow Nasal Cannula
DeviceTo compare the effects of NIV (Trilogy Evo®) and HFNC (myAirvo2®) in patients with chronic hypercapnic COPD.
Noninvasive Ventilation
Deviceto compare the effects of NIV (Trilogy Evo®) and HFNC (myAirvo2®) in patients with chronic hypercapnic COPD
Treatment groups
38 Participants
are divided into 2 treatment groupsGroup A: HFNC-NIVExperimental treatment 2 interventions
Group B: NIV-HFNCExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
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 frSecondary outcomes
1
TCO2
Transcutaneous CO₂ (SenTec V-Sign, SenTec AG, Switzerland) will be measured three times as a surrogate marker for hypercapnia.
Time frame
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 122
Compliance
During the six-week application period of each device, the actual average daily usage time and the percentage of days with at least four hours of usage (number of days with ≥4 hours of use/ total number of applied days) ×100 will be assessed.
Time frame
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: