Detailed statistical analysis plan for the pulmonary protection trial.

Area of Science:

• Cardiology
• Pulmonology
• Critical Care Medicine

Background:

• Cardiac surgery involving cardiopulmonary bypass can lead to pulmonary dysfunction.
• Chronic obstructive pulmonary disease (COPD) patients are particularly vulnerable to pulmonary complications.
• Pulmonary perfusion strategies are being investigated to mitigate these risks.

Purpose of the Study:

• To evaluate the effect of pulmonary perfusion on pulmonary function in COPD patients undergoing cardiac surgery.
• To present the statistical plan for the Pulmonary Protection Trial to ensure rigorous and unbiased reporting.
• To avoid outcome reporting bias, selective reporting, and data-driven results.

Main Methods:

• Randomized, parallel-group clinical trial involving 90 COPD patients.
• Intervention: Pulmonary perfusion with oxygenated blood or Custodiol™ HTK solution versus no pulmonary perfusion.
• Blinded assessment of patients, statisticians, and outcome adjudicators.
• Primary outcome: Oxygenation index post-cardiopulmonary bypass.
• Secondary outcomes: Intubation time, ICU-free days, hospital-free days, mortality, and serious adverse events.

Main Results:

• The primary outcome is the oxygenation index measured from 10-15 minutes after cardiopulmonary bypass until 24 hours post-procedure.
• Secondary outcomes include various clinical endpoints and safety measures, such as mortality and specific serious adverse events.

Conclusions:

• The Pulmonary Protection Trial investigates the impact of pulmonary perfusion during cardiopulmonary bypass in COPD patients.
• A preserved oxygenation index may suggest a beneficial effect of pulmonary perfusion.
• Findings could support a multicenter trial for more clinically relevant outcomes.