Status:
COMPLETED
Multisite Tissue Oxygenation Guided Perioperative Care in Cardiac Surgery
Lead Sponsor:
Yale University
Collaborating Sponsors:
Tianjin Chest Hospital
Conditions:
Brain Ischemia Hypoxia
Muscle; Ischemic
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
The BOTTOMLINE-CS trial is an international, open, single-center, pragmatic, randomised controlled trial to investigate whether multisite tissue oxygen saturation monitoring-guided perioperative care ...
Detailed Description
Short title: BOTTOMLINE-CS trial Methodology: International, open, single-center, pragmatic, randomised controlled trial Research sites: Tianjin Chest Hospital Objectives: To investigate whether multi...
Eligibility Criteria
Inclusion
- Patients aged ≥ 60 years scheduled for elective off-pump CABG.
Exclusion
- Inability or refusal to provide consent of participation
- Preoperative requirement of respiratory support (intubation, CPAP or BiPAP, or high-flow oxygen (\>10 L/min))
- Preoperative requirement of external cardiac assist device
- Urgent or emergent surgery
- Patients expected to die within 30 days of randomization
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2024
Estimated Enrollment :
1960 Patients enrolled
Trial Details
Trial ID
NCT04896736
Start Date
June 8 2021
End Date
February 2 2024
Last Update
March 25 2024
Active Locations (1)
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1
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China