Tokyo, May 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061356) titled 'A study investigating the persistence of respiratory effects of high-flow nasal cannula (HFNC) in stable post-extubation patients' on May 1.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - St. Marianna University School of Medicine, Department of Emergency and Critical Care Medicine

Condition: Condition - Acute hypoxemic respiratory failure Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the persistence of respiratory physiological effects of HFNC (functional residual capacity increase and ventilation homogenization due to PEEP effect, and reduction of work of breathing due to dead space washout) in stable patients recovering from hypoxemic respiratory failure (clinically stable for more than 6 hours after HFNC weaning post-extubation), and to exploratorily identify clinical background factors of patients in whom these effects persist. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - High-flow nasal cannula (HFNC) at 30 L/min for 30 minutes, followed by standard oxygen therapy via nasal cannula for 30 minutes. FiO2/flow adjusted to maintain SpO2 92-96%. Interventions/Control_2 - Standard oxygen therapy via nasal cannula for 30 minutes, followed by high-flow nasal cannula (HFNC) at 30 L/min for 30 minutes. FiO2/flow adjusted to maintain SpO2 92-96%.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients diagnosed with acute hypoxemic respiratory failure (P/F ratio <=300) during endotracheal intubation management in ICU 2. Patients who underwent PEEP adjustment with EIT during intubation management 3. Patients who had esophageal pressure tube inserted for transpulmonary pressure monitoring during intubation management 4. Patients who used HFNC after extubation 5. Patients who have been weaned from HFNC 30%/30L for 6-24 hours or more and have oxygen requirements 6. Patients who provided written informed consent for this study Key exclusion criteria - 1. Pregnant or breastfeeding 2. Age under 18 years 3. Consciousness disturbance 4. Pneumothorax findings on chest X-ray or CT 5. COPD GOLD stage IV 6. Contraindication to esophageal pressure measurement and/or EIT (electrical impedance tomography) monitoring 7. Patients with tracheostomy 8. End-of-life status or palliative care goals 9. Other patients judged inappropriate by the investigator Target Size - 34

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 24 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070202

Disclaimer: Curated by HT Syndication.