Multisite Tissue Oxygenation Guided Perioperative Care in Cardiac Surgery (BOTTOMLINECS)

Yale University

Status: Completed

Conditions: Brain Ischemia Hypoxia; Muscle Hypoxia; Muscle; Ischemic

Treatments: Other: Multisite tissue oxygenation-guided care; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04896736

2021KY-008-01

000

Details and patient eligibility

About

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 reduces composite complications within 30 days of randomization in off-pump coronary artery bypass grafting.

Full description

Short title: BOTTOMLINE-CS trial Methodology: International, open, single-center, pragmatic, randomised controlled trial Research sites: Tianjin Chest Hospital Objectives: To investigate whether multisite tissue oxygen saturation monitoring-guided perioperative care reduces composite complications within 30 days of randomization in off-pump coronary artery bypass grafting Number of patients: 1960 patients (980 per arm, two arms) Inclusion criteria: Patients aged ≥ 60 years undergoing elective off-pump coronary artery bypass grafting Exclusion criteria: Patient refusal, clinician refusal, preoperative requirement of respiratory support (intubation, CPAP or BiPAP, or high-flow oxygen (>10 L/min)), preoperative requirement of external cardiac assist devices, emergent or urgent surgery, patients expected to die within 30 days, current participation in another clinical trial Statistical analysis: Analyses will be performed on a modified intention-to-treat basis including all randomized patients who had undergone the scheduled surgery and had the record of the primary outcome. Summary statistics for each group, treatment effects, 95% confidence intervals, and p values will be presented for primary and secondary outcomes, and process measures. The primary outcome is a composite of complications arising within 30 days from randomization and will be analyzed using a logistic regression model.

Proposed start date: May 1, 2021 (First patient to be recruited) Proposed end date: April 30, 2023 (Last patient to be recruited) Study duration: 48 months (Starting from the first patient recruitment, spanning patient recruitment, data analysis, and manuscript writing and submission)

Enrollment: 1,960 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged ≥ 60 years scheduled for elective off-pump CABG.

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,960 participants in 2 patient groups

Multisite tissue oxygenation monitoring-guided care

Experimental group

Description:

Details are as follows. • Monitoring: SctO2 monitored using two probes placed on left and right forehead. SstO2 monitored using one probe placed over the forearm brachioradialis muscle on the arm not used for non-invasive blood pressure monitoring. • Baseline: The first baseline is measured 12-48 hours before surgery, with the patient supine, awake, calm, eyes closed, and breathing room air or oxygen that is equivalent to the home oxygen rate for patients using home oxygen. * Goals: Maintain both SctO2 and SstO2 within 90-110% of the baseline level. * Trigger of intervention: SctO2/SstO2 outside of the 90-110% baseline range. * Diagnosis: * Care team: The caregivers providing SctO2/SstO2-guided care will be trained and given the opportunity to use the intervention protocol in at least 20 patients before the formal study. * Treatments: Refer to the algorithm to restore SctO2/SstO2 within 90-110% baseline range.

Treatment:

Other: Multisite tissue oxygenation-guided care

Usual care

Active Comparator group

Description:

Patients in the control group will be managed by clinical staff according to usual care. Patients in this group will be monitored using the same tissue oximeter used in the intervention group; however, the screen will be covered by an opaque cloth to prohibit the care givers seeing the monitoring data. The same baseline measurements will be performed in patients allocated to the usual care group.

Treatment:

Other: Usual care