Comparing two types of high-flow nasal cannula for patients at risk after extubation
Comparison of Asymmetric High-flow Nasal Cannula (HFNC) and Standard HFNC in Post Extubation High-risk Group: A Prospective, Single-center, Open-labeled, Randomized Controlled Pilot Study
This study is testing if a new type of high-flow nasal cannula can help patients who are at risk of breathing problems after being taken off a ventilator, compared to the standard version.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06301035 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Asymmetric High-flow Nasal Cannula (HFNC) compared to Standard HFNC in patients who are at high risk of respiratory failure after being extubated from mechanical ventilation. The study focuses on patients who have undergone endotracheal intubation and aims to determine if the asymmetric design can reduce the rate of reintubation. Participants will be monitored for their respiratory status and overall outcomes following extubation. The trial is designed to provide insights into optimizing respiratory support for vulnerable patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older who have been on mechanical ventilation for over 24 hours and are at high risk for reintubation.
Not a fit: Patients who do not meet the inclusion criteria or those who are not at high risk for extubation failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the need for reintubation in high-risk patients, improving their recovery and overall outcomes.
How similar studies have performed: Previous studies have shown promising results with high-flow nasal cannula therapies, suggesting that this approach may be beneficial, though the specific asymmetric design is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. 19 years of age or older
2. Patients who applied mechanical ventilation treatment for more than 24 hours before the excision
3. Patients who underwent endotracheal intubation rather than tracheal incision
4. Planned extubation after successful spontaneous breathing trial (SBT)
5. Reintubation High Risk Patients: If any of the following conditions are met
1. Age \> 65
2. Acute Physiology and Chronic Health Evaluation(APACHE) II on the day of extubation \> 12
3. Body mass index (BMI) \> 30 kg/m2
4. Inability to deal with respiratory secretions
* improper cough reflex
* If at least three aspirations are required in the 8 hours prior to the discharge
5. Difficult or long delay in mechanical ventilation
* The first attempt to leave the mechanical ventilation failed
6. Charlson Commercial Index (CCI) at least 2 categories of comorbidities
7. Heart failure is the main indication of mechanical ventilation application
8. Moderate to severe chronic obstructive pulmonary disease
9. If there is a problem with airway openness (high risk of developing laryngeal edema)
* a woman
* Oral endotracheal intubation maintenance period of at least 3 days
* Difficult to intubate endotracheally (difficult airway)
10. Long-term mechanical ventilation application: When applied for more than 7 days
Exclusion Criteria:
1. a patient with a tracheostomy tube
2. Contraindicated application of nasal interfaces
* a nasal disorder
3. Continuous positive pressure (CPAP) application contraindications
* pneumothorax, blistering lung disease, head trauma, cranial facial surgery, airway foreign matter, unstable hemodynamics, etc
4. EIT application contraindications
* Patients using implantable electronic medical devices (such as implantable defibrillators, pacemakers or spinal cord stimulators)
* a patient with hyperhidrosis
* a patient whose physical movements are not controlled
* a pregnant woman
* BMI 50 or higher
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Chi Ryang Chung, MD, PhD
- Email: ccrzzang@gmail.com
- Phone: +82-2-3410-3430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.