2.5 Versus 5 Minutes Trial

Not Applicable

Completed

• Conditions: Hypotension
• Interventions: Other: Oscillometric blood pressure monitoring at 5-minute intervals; Other: Oscillometric blood pressure monitoring at 2.5-minute intervals

• Registration Number: NCT06314074
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-10
• Study First Submitted QC: 2024-03-10
• Study Start: 2024-03-12
• Study First Posted: 2024-03-15
• Primary Completion: 2024-10-24
• Study Completion: 2024-10-31
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oscillometric blood pressure monitoring at 5-minute intervals	Oscillometric blood pressure monitoring at 5-minute intervals	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.
Oscillometric blood pressure monitoring at 2.5-minute intervals	Oscillometric blood pressure monitoring at 2.5-minute intervals	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.

Primary Outcome Measures

Name	Time	Method
Time-weighted average mean arterial pressure <65 mmHg	Beginning of surgery until the end of surgery	The primary endpoint will be the time-weighted average mean arterial pressure \<65 mmHg (continuous outcome) - defined as the area under a MAP of 65 mmHg divided by the time of continuous finger-cuff blood pressure monitoring \[mmHg\].

Secondary Outcome Measures

Name	Time	Method
Episodes of a mean arterial pressure <50 mmHg	Beginning of surgery until the end of surgery	Absolute number of patients with at least one 1-minute episode of a mean arterial pressure \<50 mmHg.
Norepinephrine dose	Beginning of surgery until the end of surgery	Time-weighted cumulative amount of norepinephrine indexed to body weight \[µg/kg/min\].

Trial Locations

Locations (1)

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany