2.5 Versus 5 Minutes Trial

Universitätsklinikum Hamburg-Eppendorf264 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

264

Conditions

Hypotension

Interventions

Oscillometric blood pressure monitoring at 2.5-minute intervalsOTHER

Oscillometric blood pressure will be measured at 2.5-minute intervals during surgery.

Oscillometric blood pressure monitoring at 5-minute intervalsOTHER

Oscillometric blood pressure will be measured at 5-minute intervals during surgery.

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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)

Locations (1)

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Outcomes

Primary Outcomes

Time-weighted average mean arterial pressure <65 mmHg

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 \[mmHg\].

Time frame: Beginning of surgery until the end of surgery

Secondary Outcomes

Episodes of a mean arterial pressure <50 mmHg

Absolute number of patients with at least one 1-minute episode of a mean arterial pressure \<50 mmHg.

Time frame: Beginning of surgery until the end of surgery

Norepinephrine dose

Time-weighted cumulative amount of norepinephrine indexed to body weight \[µg/kg/min\].

Time frame: Beginning of surgery until the end of surgery

Data from ClinicalTrials.gov

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