Comparison of Extubation Success between Prophylactic Helmet NIV and Facemask NIV in High-Risk Postextubation Patients; A Randomized Controlled Trial

Phase 4

Completed

• Conditions: Extubation success within the first 48 hours without post-extubation respiratory failure that needs immediate intubation and invasive mechanical ventilation in high risk groups; Helmet NIV, Facemask NIV, high-risk extubation failure, extubation success

• Registration Number: TCTR20230214002
• Lead Sponsor: King Chulalongkorn Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-01-31
• Study Start: 2023-02-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patients over the age of 18 who had been on invasive mechanical ventilation in the medicine ICU and general ward for at least 48 hours and were considered ready for extubation after a successful spontaneous breathing trial with pressure support (PSV) mode were eligible if they were at high risk of extubation failure as defined by the following criteria: older than 65 years, those with preexisting chronic cardiac or lung disease, those with an APACHE II score of more than 12, those with a BMI of more than 30 kg/m2, those with difficult or prolonged breathing for more than seven days, and those with a Charlson Comorbidity Index greater than two on the day of extubation. Preexisting cardiac disease included left ventricular dysfunction, defined by a left ventricular ejection fraction (LVEF) equal to or below 45% from any causes; a history of cardiogenic pulmonary edema; documented ischemic heart disease; or permanent atrial fibrillation. Chronic obstructive pulmonary disease, obesity hypoventilation syndrome, and restrictive lung disease were identified as preexisting chronic pulmonary diseases.

Exclusion Criteria

Patients with long-term NIV use, neuromuscular disease (i.e., myopathy or myasthenia gravis), traumatic brain injury leading to intubation, accidental or self-extubation, and do-not-resuscitation after extubation, and having contraindications to NIV use

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
extubation success at 48 hours after extubation extubation success

Secondary Outcome Measures

Name	Time	Method
IV intolerance rate within 24 hours after extubation NIV intolerance rate,complication of NIV use within 24 hours after extubation complication of NIV use