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

Not Applicable

• Conditions: Postoperative Delirium; Cardiac Surgery
• Interventions: Device: RIPC induced with 3 cycles of 5 minutes of ischaemia and 5 minutes of reperfusion

• Registration Number: NCT05434455
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-28
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-06-30
• Study Start: 2022-07-01
• Primary Completion: 2022-07-14
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 216

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RIPC	RIPC induced with 3 cycles of 5 minutes of ischaemia and 5 minutes of reperfusion	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.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium	7 days postoperatively or before discharge, whichever came first	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