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Effect of Cerebral Oxygen Saturation Intervention (ECOS)

Primary Purpose

Postoperative Delirium

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Increase the SCO2 value
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Delirium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • FirstXianJiaotongU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

the trial group

the control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 25, 2019
Last Updated
April 10, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT04212988
Brief Title
Effect of Cerebral Oxygen Saturation Intervention
Acronym
ECOS
Official Title
Effect of Cerebral Oxygen Saturation Interventionon Postoperative Delirium After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
April 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .
Detailed Description
Postoperative delirium (POD) is a common complication after cardiac surgery. Imbalance of cerebral oxygen supply and demand is one of the pathogenesis of postoperative delirium. The perioperative cerebral oxygen levels and postoperative delirium highly correlated, while as a high incidence of cerebral oxygen desaturation(SCO2) in cardiac surgery, especially in extracorporeal circulation. Near infrared spectroscopy (NIRS) can monitor the SCO2 continuously, noninvasively, simultaneously on bilateral cerebral hemisphere, and monitoring will not restricted by extracorporeal circulation.Using NIRS to moniter and intervene thecerebral oxygen levels in extracorporeal circulation of heart surgery patients ,thereby reducing the incidence of postoperative delirium. This hypothesis has a very important clinical value. This study intends to include 140 patients, who requires extracorporeal circulation cardiac surgical treatment. All cases will be divided into trial group and control group preoperative follow-up.Two groups of patients in surgery will be both performed the investigator's existing standerd monitoring and surgery process. The trial group cases will be given NIRS monitoring in the whole surgical procedure. And once the SCO2 value below ideal levels (80% of the basic level or 50% of the absolute value), the intervention process will be started immediately to correct the low cerebral oxygen status, by adjusting the position of extracorporeal circulation arteriovenous catheter, stabilizing the mean arterial pressure, increasing oxygen supply and , adjusting the pump speed, etc. The control group cases will be only placed the probe of NIRS moniter. In 72 hours after the surgery , all patients will be assessed POD by cardiac surgery intensivecare unit(CICU) physicians according to delirium scale . This project intends to research monitoring brain oxygen supply and intervention can reduce the incidence of postoperative delirium.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single blind
Masking
Participant
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the trial group
Arm Type
Experimental
Arm Description
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.
Arm Title
the control group
Arm Type
Placebo Comparator
Arm Description
In control group patients, only place the probe for NIRS monitor.
Intervention Type
Procedure
Intervention Name(s)
Increase the SCO2 value
Intervention Description
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.
Primary Outcome Measure Information:
Title
the incidence of POD
Description
the incidence of postoperative delirium in the cases after 3 days after surgery
Time Frame
3 days after sugery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 . Exclusion Criteria: 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.
Facility Information:
Facility Name
FirstXianJiaotongU
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Cerebral Oxygen Saturation Intervention

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