Effect of RIPC on the Prevention of POD in Patients Undergoing Cardiac Surgery

Fudan University

Status: Not yet enrolling

Conditions: Cardiac Surgery; Postoperative Delirium

Treatments: Device: RIPC induced with 3 cycles of 5 minutes of ischaemia and 5 minutes of reperfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05434455

2022RIPC-delirium

Details and patient eligibility

About

Postoperative delirium (POD) is one of the most frequent neurological complications in elderly patients and is closely associated with longer ICU stay and hospitalization, deterioration of long-term neurocognitive function, and increased mortality. The incidence of POD is significantly higher in elderly patients undergoing cardiac surgery than in other populations. Therefore, the prevention of POD is an important clinical problem to be solved urgently. In this study, we intend to observe the effect of RIPC on the prevention and treatment of POD in patients undergoing cardiac surgery through a prospective randomized controlled trial.

Enrollment: 216 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing elective cardiac surgery;
• age ≥ 18 yr;
• any sex;
• American Society of Anesthesiologists (ASA) class ≥II class;
• New York Heart Association (NYHA) ≥II class.

Exclusion criteria

• emergency surgery;
• a history of cardiovascular surgery;
• peripheral vascular disease affecting the upper limbs;
• acute myocardial infarction (MI) up to 14 days before surgery;
• a history of severe injuries and operations within 3 months before cardiac surgery;
• a history of cancer and chronic autoimmune diseases.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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216 participants in 2 patient groups

RIPC

Experimental group

Description:

RIPC was induced with 3 cycles of 5 minutes of ischaemia and 5 minutes of reperfusion on the upper arm. By using blood pressure cuff inflation, patients in the RIPC group were exposed to a pressure 50 mmHg higher than the systolic radial artery pressure baseline.

Treatment:

Device: RIPC induced with 3 cycles of 5 minutes of ischaemia and 5 minutes of reperfusion

Con

No Intervention group

Description:

The control group had a deflated cuff placed on the upper arm for the same time.