Comparison of Extubation success between prophylactic Helmet NIV and High-flow Nasal Cannula in high risk of reintubation in post-extubation patients; A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240322004

Enrollment

Registered

2024-03-22

Start date

2023-03-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who have been intubated for at least 48 hours and have passed a Spontaneous Breathing Trial (SBT) assessment and belong to a group at risk of re-intubation helmet NIV HFNC high-risk extubation failure extubation success

Interventions

Patients will receive helmet NIV immediately after extubation by pulmonologist. The pulmonologist and critical care team will be responsible for setting up and controlling the equipment. The ventilati

s needs, with the target oxygen saturation (SpO2) being above 92%. After 24 hours of receiving high-flow oxygen, if the patient still requires oxygen, it will be switched to normal oxygen therapy.

Experimental Device,Active Comparator Device

Helmet NIV,High-Flow nasal cannula

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged > 18 years who consent to participate in the research project, with complete decision-making capacity, intubated for at least 48 hours in the intensive care unit or general ward of Chulalongkorn Hospital,Patients who have been assessed for readiness to wean from mechanical ventilation using the Spontaneous Breathing Trial (SBT) method, high risk of reintubation within 48 hours, Patients without or with minimal risk of aspiration.

Exclusion criteria

Exclusion criteria: Patients previously treated with continuous positive airway pressure (CPAP), Patients with contraindications for positive pressure devices such as helmet non-invasive ventilation (NIV) and high-flow nasal cannula (HFNC), including:Cardiac or respiratory arrest, unstable vital signs, defined as systolic blood pressure < 90 mmHg and mean arterial pressure > 65 mmHg requiring vasopressor therapy, Failure of major organ systems, Upper airway obstruction or inability to clear secretions, Previous facial, nasal, or upper airway surgery, Claustrophobia, Patients diagnosed with neuromuscular junction disease or HIV, Mentally ill patients, Cancer patients or those in terminal illness, Patients with traumatic brain injury leading to intubation, Patients who have self-extubated, Patients expressing a desire not to be reintubated after extubation, Pregnant patients, Tracheostomized patients, Patients with elevated carbon dioxide levels during Spontaneous Breathing Trial (SBT) testing.

Design outcomes

Primary

Measure	Time frame
success rate of extubation in high risk of extubation failure patient 48 hours after extubation rate of reintubation	—

Secondary

Measure	Time frame
re-intubation rate in 7 days after extubation 7 days rate of reintubation,risk factors of extubation failure 7 days APACHE score, CCI score, SOFA, underlying disease,gas exchange, vital sign parameter and comfort score 48 hours after extubation arterial blood gas, vital sign and feeling of patient	—

Countries

Thailand

Contacts

Public ContactPanyaporn Temphatthrachok

King Chulalongkorn Memorial Hospital

boompanyaporn@gmail.com0990590099

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026