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

NCT05434455 | Unknown

• 1 other identifier: 2022RIPC-delirium
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Delirium; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

RIPC

EXPERIMENTAL

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

Con

NO INTERVENTION

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

Interventions

RIPC induced with 3 cycles of 5 minutes of ischaemia and 5 minutes of reperfusion DEVICE

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.

RIPC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Emergence Delirium

Interventions

Reperfusion

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Perfusion; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 28, 2022
• Study Start: July 1, 2022
• Primary Completion: July 14, 2022
• Study Completion: December 31, 2023
• Last Updated: June 30, 2022

Record last verified: 2022-06