2.5 Versus 5 Minutes Trial

NCT06314074 | Completed

• 1 other identifier: 2023-101143-BO-ff
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Episodes of a mean arterial pressure <50 mmHg

  Beginning of surgery until the end of surgery

• Norepinephrine dose

  Beginning of surgery until the end of surgery

Study Arms (2)

Oscillometric blood pressure monitoring at 2.5-minute intervals

EXPERIMENTAL

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 monitoring at 5-minute intervals

ACTIVE COMPARATOR

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

Interventions

Oscillometric blood pressure monitoring at 2.5-minute intervals OTHER

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

Oscillometric blood pressure monitoring at 2.5-minute intervals

Oscillometric blood pressure monitoring at 5-minute intervals OTHER

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

Oscillometric blood pressure monitoring at 5-minute intervals

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

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

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Karim Kouz, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Karim Kouz, Principal Investigator

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 15, 2024
• Study Start: March 12, 2024
• Primary Completion: October 24, 2024
• Study Completion: October 31, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-03

Locations

DE (1)