Effect of Cerebral Oxygen Saturation Intervention

NCT04212988 | Completed

• 1 other identifier: XJTU1AF-CRF-2017-009
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative delirium (POD) is a common complication after cardiac surgery,and the pathogenesis is considered imbalance of cerebral oxygen. It may induce the POD incidence by monitering and intervening the low cerebral oxygen desaturation(SCO2) in cardiac surgery .Near infrared spectroscopy (NIRS) will be used for monitering the cerebral oxygen levels.140 case will be included and divided in to trial and control group. The primary outcome is POD In 72 hours after the surgery , which is assessed according to delirium scale .

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• the incidence of POD

  the incidence of postoperative delirium in the cases after 3 days after surgery

  3 days after sugery

Study Arms (2)

the trial group

EXPERIMENTAL

The interwention process will be started once the SCO2 value below ideal levels (80% of the basic level or 50% of absolute value), by adjusting the position of extracorporeal circulation arteriovenous catheter, balancing arterial pressure, increasing oxygen supply , adjusting pump speed ,etc.

Procedure: Increase the SCO2 value

the control group

PLACEBO COMPARATOR

In control group patients, only place the probe for NIRS monitor.

Procedure: Increase the SCO2 value

Interventions

Increase the SCO2 value PROCEDURE

The interwention process will be started once the SCO2 value below ideal levels (80% of the basic level or 50% of absolute value), by adjusting the position of extracorporeal circulation arteriovenous catheter, balancing arterial pressure, increasing oxygen supply , adjusting pump speed ,etc.

the control group; the trial group

Eligibility Criteria

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

You may qualify if:

• Participate and sign the informed consent voluntary;
• Over 18 years of age;
• Who recieve the heart surgery under extracorporeal circulation;
• Able to communicate and abey the experimental requirements well .

You may not qualify if:

• Refused to sign a consent form;
• Less than 18 years of age;
• With history of nervous, mental, and cerebrovascular disease;
• With history of alcohol or apsychiatric drug addiction;
• Can't cooperate the evaluation: dementia, dysaudia, visually impaired , etc;
• Critically diseases: severe liver and kidney dysfunction, cardiac shock or IABP placement status.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

FirstXianJiaotongU

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Emergence Delirium

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

Study Design

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

Model Details: single blind

Study Record Dates

• First Submitted: December 25, 2019
• First Posted: December 30, 2019
• Study Start: January 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: April 7, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)