Remote ischemic conditioning for the prevention of stroke-associated pneumonia (RICA-2): protocol for a multicenter,...

Area of Science:

• Neurology
• Critical Care Medicine
• Clinical Trials

Background:

• Stroke-associated pneumonia (SAP) is a frequent complication of acute ischemic stroke (AIS), increasing mortality and impacting long-term survival.
• Remote ischemic conditioning (RIC) is a potential preventive strategy for SAP, necessitating further clinical investigation.
• Understanding SAP's impact is crucial for developing effective interventions in stroke care.

Purpose of the Study:

• To evaluate the efficacy and safety of remote ischemic conditioning (RIC) in preventing stroke-associated pneumonia (SAP).
• To compare RIC versus Sham-RIC in patients experiencing acute ischemic stroke (AIS) within 24 hours of symptom onset.
• To establish RIC as a potential adjuvant therapy for SAP prevention in AIS patients.

Main Methods:

• The RICA-2 trial is a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial.
• 1650 patients aged ≥18 years with AIS (NIHSS ≥ 4) within 24 hours of symptom onset will be enrolled.
• Participants will be randomized to receive RIC (200 mmHg cuff inflation) or Sham-RIC (60 mmHg) twice daily for seven days.

Main Results:

• Primary efficacy endpoint is the incidence rate of stroke-associated pneumonia (SAP).
• Safety incidence will be meticulously recorded and reported throughout the trial.
• The study aims to provide robust data on RIC's effectiveness and safety profile.

Conclusions:

• Remote ischemic conditioning (RIC) shows promise as a preventive therapy for stroke-associated pneumonia (SAP).
• The RICA-2 trial is designed to confirm RIC's role as an adjuvant treatment in AIS patients.
• Findings will inform clinical practice regarding SAP prevention strategies.