Remote Ischemic Conditioning for Stroke-associated Pneumonia

Study Overview
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Brief Summary
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Verifying whether remote ischemic adaptation can reduce the occurrence of stroke related pneumonia in acute stroke patients within 24 hours of onset

Detailed Description
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Verifying whether remote ischemic adaptation can reduce the occurrence and safety of stroke related pneumonia in acute stroke patients within 24 hours of onset

Official Title
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The Preventive Effect of Remote Ischemic Conditioning in Reducing Stroke-Associated Pneumonia: an Investigator-initiated, Multicenter, Randomized, Double-blind, Sham-controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Device: Remote ischemic conditioning
* Device: Sham remote ischemic conditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 years old; Diagnosis of acute ischemic stroke; Remote ischemic conditioning or sham-remote ischemic conditioning can be treated within 24 hours after stroke onset NIHSS score≥4; Subject or his or her legally authorized representative was able to provide informed consent. Exclusion Criteria: During the screening period, body temperature ≥ 38 ℃; Evidence of lung infection, urinary tract infection or other infectious diseases during the screening period Expected lifespan less than 7 days Mechanical ventilation is expected to be required within 7 days; Anti-infective drug were used within 7 days prior to stroke; Uncontrolled hypertension with medication (defined as systolic blood pressure ≥200 mmHg and/or diastolic blood pressure ≥110 mmHg); There are contraindications for remote ischemic conditioning (such as skin and soft tissue injury, fractures, peripheral arterial disease, etc. in the upper limbs); History of autoimmune disease or malignancies; Use of immunosuppressive drug within the preceding 3 months; Pregnant or lactating, or pregnancy test positive; Current participation in another investigational trial; Other conditions are not suitable for this trial as evaluated by researchers.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Remote ischemic conditioning (RIC) -200mmHg and best medical management | Device: Remote ischemic conditioning<br>* The RIC procedure consists of five cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 200 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.<br>|
| Sham Comparator: Sham group<br>Remote ischemic conditioning (RIC) -60mmHg and best medical management | Device: Sham remote ischemic conditioning<br>* The RIC procedure consists of five cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 60 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke-associated pneumonia | Stroke-associated pneumonia incidence rate | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician diagnosed pneumonia | Physician diagnosed pneumonia incidence rate | 7 days | 
| Physician diagnosed pneumonia | Physician diagnosed pneumonia incidence rate | 8-90 days | 
| Modified Rankin scale 0-1 | defined by 0-1 of the modified Rankin Scale (mRS) | 90 days after the onset of symptoms | 
| Modified Rankin scale 0-2 | defined by 0-2 of the modified Rankin Scale (mRS) | 90 days | 
| Modified Rankin scale | Shift analysis | 90 days | 
| EQ-5D-5L | The score of EQ-5D-5L | 90 days | 
| NIHSS stroke scale | The score of NIHSS stroke scale | 24 hours | 
| NIHSS stroke scale | The score of NIHSS stroke scale | 7 days | 
| Urinary tract infections | Urinary tract infections incidence rate | 7 days | 
| Infections | Infections incidence rate | 7 days | 
| All-cause mortality | All-cause mortality incidence rate | 90 days | 
| Inpatient days | Total inpatient days | 90 days |