Protocolized Post-Extubation Respiratory Support to prevent reintubation: protocol and statistical analysis plan for...

Area of Science:

• Critical Care Medicine
• Respiratory Therapy
• Clinical Trials

Background:

• Reintubation after mechanical ventilation occurs in nearly 15% of critically ill adults, increasing mortality.
• Previous studies suggest post-extubation respiratory support benefits specific patient groups.
• The effectiveness of a universal, protocolized approach to post-extubation support remains unclear.

Purpose of the Study:

• To determine if protocolized post-extubation respiratory support reduces the overall reintubation rate compared to usual care.
• To evaluate the impact of a respiratory therapist-driven protocol for non-invasive ventilation or high-flow nasal cannula.
• To assess reintubation rates within 96 hours of extubation in a medical intensive care unit.

Main Methods:

• Pragmatic, cluster cross-over trial (PROPER) conducted from October 2017 to March 2019.
• Comparison of usual care versus protocolized post-extubation respiratory support (non-invasive ventilation or high-flow nasal cannula).
• Enrolled adults undergoing extubation from invasive mechanical ventilation, excluding those with <12 hours ventilation, 'Do Not Intubate' orders, or prior reintubation.

Main Results:

• Primary outcome: reintubation within 96 hours of extubation.
• Secondary outcomes not detailed in the abstract.
• Trial enrolled approximately 630 patients.

Conclusions:

• The PROPER trial aims to provide evidence on the efficacy of protocolized post-extubation respiratory support.
• Findings will inform clinical practice guidelines for respiratory support after mechanical ventilation.
• Results will be disseminated through peer-reviewed publications and scientific conferences.