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

Phase 4

Completed

• 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

• Registration Number: TCTR20240322004
• Lead Sponsor: ational Research Council of Thailand(NRCT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-12-31
• Study Start: 2024-03-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
success rate of extubation in high risk of extubation failure patient 48 hours after extubation rate of reintubation

Secondary Outcome Measures

Name	Time	Method
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