The Effects of Individualized Oxygen Dynamic on Prognosis of Patients With High-risk Cardiac Surgery

Not Applicable

Completed

• Conditions: Cardiac Disease; High Risk Sex

• Registration Number: NCT03103633
• Lead Sponsor: The First Affiliated Hospital of Anhui Medical University

Brief Summary

Anesthesia-related factors have been linked to poor perioperative outcomes. Our observational study suggested that the cumulative duration of a triple-low state \[intraoperative low mean arterial pressure (MAP), low bispectral index (BIS), and low target effect-site concentration(Ce) \]was associated with poorer 30-day mortality.This randomized, prospective study based on individualized Oxygen dynamics is designed to confirm this association in high-risk patients cardiopulmonary bypass (CPB).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-05
• Status Verified: 2017-04
• Study First Submitted: 2017-04-01
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-06
• Primary Completion: 2018-06-30
• Study Completion: 2018-07-30
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

1. Written informed consent;
2. Selective cardiac surgery and general anesthesia patients;
3. Age 18-90 yrs;
4. Anesthesia Society of American (ASA) Scale II-IV
5. European System for Cardiac Operative Risk Evaluation score equal to or greater than 6 or left ventricular ejection fraction lower than 50%

Exclusion Criteria

1. Preoperative cardiac ejection fraction<30 %;
2. History of anesthesia awareness;
3. History or anticipation of difficult intubation;
4. Unanticipated intraoperative conditions, including haemorrhage, obstinate resuscitation failure,multiple cardiopulmonary bypass procedures, severe hypotension or hypoxemia;
5. long-term preoperative use of anticonvulsant agents, opiates, benzodiazepines or cocaine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
30-day mortality	30-day after surgery	Data for duration of postoperative 30-day all-cause mortality
Major postoperative complications(i.e., Rate of low cardiac output syndrome, stroke, myocardial ischemia, infection,reoperation, and need for dialysis)	30-day after surgery	Number of Participants with major complications extracted after 30-day follow-up
The change of incidence of postoperative delirium	The 1,2,3 day after surgery	Through Confusion Assessment Method (CAM)to assess the incidence of the postoperative delirium
1,3,5-year mortality	1,3,5-year after surgery	Data for duration of 1,3,5-year all-cause mortality is extracted after 1-year follow-up

Secondary Outcome Measures

Name	Time	Method
The change of incidence of postoperative cognition dysfunction	1 day before surgery, the 3,7 day after the surgery	The neuropsychological tests performed at the day before the surgery,the 3,7 day after the surgery respectively.
postoperative hospital stay	30-day after surgery	Data for duration of postoperative hospital stay is extracted after 30-day follow-up
The occurrence of cardiovascular events	30-day after surgery	Data for duration of the occurrence of cardiovascular events is extracted 30-day follow-up
The incidence of any adverse events	30-day after surgery	Including kidney or brain related adverse events 30-day after surgery

Trial Locations

Locations (1)

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China