High Flow Nasal Oxygen for Exacerbation COPD

Launched by FRANCISCUS GASTHUIS · Oct 10, 2023

Keywords

ClinConnect Summary

This clinical trial is looking into the use of High Flow Nasal Oxygen to see if it works as well as a different treatment called non-invasive ventilation for patients with a serious worsening of chronic obstructive pulmonary disease (COPD). COPD is a long-term lung condition that makes it hard to breathe, and when it worsens, it can lead to high levels of carbon dioxide in the blood, which can be dangerous. The goal of this study is to determine if High Flow Nasal Oxygen is a viable option for treating these patients and to gather information for a larger study in the future.

To be eligible for this trial, participants should be over 40 years old and diagnosed with COPD, currently experiencing a severe episode where their carbon dioxide levels are elevated. However, some people are not eligible, such as those with asthma, certain heart conditions, or those who may need immediate breathing assistance through intubation. If you or a family member are considering joining this study, you can expect to receive either High Flow Nasal Oxygen or the other treatment, and the healthcare team will be monitoring your condition closely. It's important to know that participation is voluntary, and you can ask questions or opt out at any time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Known chronic obstructive pulmonary disease
• • Acute hypercapnic exacerbation of this condition, defined as: PaCO2\>45 mmHg or \>6.0 kPa and pH 7.20-7.35
• • Age \>40 years
• Exclusion Criteria:
• • Asthma
• • Immediate need for intubation, based on clinical judgement of the attending physician.
• • Impossibility to apply either one of the two interventions
• • Patient not expected to give immediate or delayed informed consent (e.g. known cognitive impairment, dementia, active serious psychiatric disease, mental retardation).
• • Established home-NIV or home CPAP, known indication for home-NIV or CPAP (e.g. OSAS or obesitas hypoventilation syndrome).
• • Impeding death
• • Concurrent (respiratory) diseases that may influence treatment efficacy: acute heart infarction, cardiogenic lung edema, massive pulmonary embolism (intermediate-high risk or more). NB; pulmonary infections (viral and bacterial) are a common cause of exacerbation and are no reason for exclusion.
• • Other acute diseases that preclude participation in the trial such as hemodynamic instability (need for vasopressors), reduced consciousness with need for intubation, severe intoxication
• • Tracheostomized patients
• • Participation in other interventional trials
• • Impossibility to admit the patient to the participating ICU or monitored ward (e.g. medium care / high dependency unit, depending on local infrastructure).
• • Previous explicit (or written) objection to participation in research - bicarbonate \<20 mmol/L