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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Effects of Remote Ischemic Preconditioning(RIPC) on the Prevention of Postoperative Delirium in Patients Undergoing Cardiac Surgery: A Pilot Randomized Clinical Trial

Conditions
-----------------
Postoperative Delirium, Cardiac Surgery

Intervention / Treatment
-----------------
* Device: RIPC induced with 3 cycles of 5 minutes of ischaemia and 5 minutes of reperfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPC<br>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. | Device: RIPC induced with 3 cycles of 5 minutes of ischaemia and 5 minutes of reperfusion<br>* 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.<br>|
| No Intervention: Con<br>The control group had a deflated cuff placed on the upper arm for the same time. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative delirium | Patients were assessed for postoperative delirium by the Confusion Assessment Method (CAM) from the time they were transferred to the ICU at the end of surgery until 7 days postoperatively or before discharge, whichever came first | 7 days postoperatively or before discharge, whichever came first |