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Efficacy and safety of high-flow oxygen therapy using an asymmetric nasal cannula for postextubation respiratory failure in patients at risk of reintubation. (Efficacy and safety of high-flow oxygen therapy using an asymmetric nasal cannula for postextubation respiratory failure in patients at risk of reintubation.)

Efficacy and safety of high-flow oxygen therapy using an asymmetric nasal cannula for postextubation respiratory failure in patients at risk of reintubation.

Tasaki Osamu

Nagasaki University Hospital

1-7-1 Sakamoto, Nagasak, Japan

tasaki-o@nagasaki-u.ac.jp

Tasaki Osamu

Nagasaki University Hospital

1-7-1 Sakamoto, Nagasaki, Japan

+81-95-819-7765

tasaki-o@nagasaki-u.ac.jp

Recruiting

April. 30, 2025

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

(1) Patients admitted to an intensive care unit (ICU) who are intubated due to a medical condition and have at least one risk item for reintubation after extubation.
(2) Patients who are 18 years of age or older at the time of consent.
(3) Patients who have received a thorough explanation of their participation in this study, and who have obtained written consent from the patient or the patient's surrogate, based on sufficient understanding.

(1) Patients intubated for respiratory management associated with surgical procedures (surgical procedures, traumatic diseases, poisoning, burns, etc.)
(2) Patients receiving continuous oxygen administration via nasal cannula (home oxygen therapy
(3) Patients with a history of pneumothorax
(4) Patients without spontaneous respiration
(5) Patients with obstruction of the nasal passages due to abnormalities of the nasal mucosa, etc.
(6) Patients with a history of CSF leakage or head injury
(7) Patients with cribriform plate abnormalities
(8) Patients with pneumoencephalopathy, pneumothorax, cystic lung disease, or pathological hypotension
(9) Patients with upper airway bypass
(10) Patients participating in clinical trials or other clinical studies
(11) Other patients who are deemed inappropriate as research subjects by the principal investigators and subinvestigators.

Both

Respiratory Failure

(1) After obtaining study consent, randomization will be performed according to a web-based blocked random sequence to allocate the patients into 2 groups: (i) S-HFNC to A-HFNC, (ii) A-HFNC to S-HFNC
(2) Extubate with AirvoTM3 and EIT
(3) Immediately after extubation, start attaching S-HFNC or A-HFNC and use it for 60 minutes.
Default setting: FIO2: 60%, Temperature: 37
FLOW:60 or 50 L/min
(60 L/min for Prong: M, L, 50 L/min for Prong: S)
(4) Measure EIT at 50-60 minutes of HFNC application
(5) Washout period of 6L of reservoir mask for 10 min.
(6) Switch to A-HFNC or S-HFNC and use for 60 min.
(Settings: FIO2: No change from HFNC at (3), FLOW: 60(or 50) L/min, Temperature: 37)
(7) Measure EIT at 50-60 minutes after HFNC
(8) Continue oxygen therapy with a target SpO2 of 92%-94%.

Improvement of respiratory workload: tidal volume (derived from deltaZ measured by EIT)

1) PEEP augmentation effect:total delta EELZ, ventral delta EELZ, dorsal delta EELZ, GI index
2) Improvement of respiratory workload other than tidal volume:ventral tidal volume, dorsal tidal volume,minute volume (=tidal volume x respiratory rate), corrected minute volume(=minute volume x PaCO2/40)
3) ROX index, Vital signs
4) PaCO2, PaO2/FIO2
5) Comfort
6) Dyspnea

+81-95-819-7229

April. 14, 2025

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