2.5 Versus 5 Minutes Trial

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Hypotension

Treatments: Other: Oscillometric blood pressure monitoring at 2.5-minute intervals; Other: Oscillometric blood pressure monitoring at 5-minute intervals

Study type: Interventional

Funder types: Other

Identifiers

NCT06314074

2023-101143-BO-ff

Details and patient eligibility

About

This is a randomized trial investigating the effect of oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - on intraoperative hypotension. Specifically, the investigators will test the primary hypothesis that oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - reduces the time-weighted average mean arterial pressure below 65 mmHg in patients having non-cardiac surgery.

Enrollment: 264 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥45 years
• scheduled for elective non-cardiac surgery under general anesthesia
• planned oscillometric blood pressure monitoring with an upper-arm cuff
• American Society of Anesthesiologists physical status class II or higher

Exclusion criteria

• emergency surgery
• arm or shoulder surgery
• pregnancy
• preoperative blood pressure differences between the right and left arm of more than 20 mmHg
• intraoperative invasive blood pressure monitoring
• previous preoperative peripheral nerve injury (such as diabetic neuropathy, carpal tunnel syndrome, or cervical radiculopathy)
• contraindication for continuous finger-cuff blood pressure monitoring (e.g., Raynaud's disease, arterial-venous shunts, or cardiac assist devices)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

264 participants in 2 patient groups

Oscillometric blood pressure monitoring at 2.5-minute intervals

Experimental group

Description:

In patients assigned to oscillometric blood pressure monitoring at 2.5-minute intervals, oscillometric upper-arm cuff blood pressure will be measured and displayed on the patient monitor every 2.5 minutes during surgery. Blood pressure will additionally measured with BLINDED continuous non-invasive finger-cuff blood pressure monitoring.

Treatment:

Other: Oscillometric blood pressure monitoring at 2.5-minute intervals

Oscillometric blood pressure monitoring at 5-minute intervals

Active Comparator group

Description:

In patients assigned to oscillometric blood pressure monitoring at 5-minute intervals, oscillometric upper-arm cuff blood pressure will be measured and displayed on the patient monitor every 5 minutes during surgery. Blood pressure will additionally measured with BLINDED continuous non-invasive finger-cuff blood pressure monitoring.

Treatment:

Other: Oscillometric blood pressure monitoring at 5-minute intervals