2.5 Versus 5 Minutes Trial

Oscillometric Blood Pressure Measurement At 2.5- Vs. 5-minute Intervals and Hypotension in Patients Having Non-cardiac Surgery: a Randomized Trial

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 Overview

• Status: Completed
• Conditions: Hypotension
• Intervention / Treatment: Other: Oscillometric blood pressure monitoring at 2.5-minute intervals; Other: Oscillometric blood pressure monitoring at 5-minute intervals

• Study Type: Interventional
• Enrollment (Actual): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Oscillometric blood pressure monitoring at 2.5-minute intervals; Oscillometric blood pressure will be measured at 2.5-minute intervals during surgery.
Active Comparator: 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.	Other: Oscillometric blood pressure monitoring at 5-minute intervals; Oscillometric blood pressure will be measured at 5-minute intervals during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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].	Beginning of surgery until the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Beginning of surgery until the end of surgery
Norepinephrine dose	Time-weighted cumulative amount of norepinephrine indexed to body weight [µg/kg/min].	Beginning of surgery until the end of surgery

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Karim Kouz, MD, Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Actual): October 24, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: March 10, 2024
• First Submitted That Met QC Criteria: March 10, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension
• Other Study ID Numbers: 2023-101143-BO-ff

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No