2.5 Versus 5 Minutes Trial

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06314074
• Other study ID #: 2023-101143-BO-ff
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Karim Kouz, MD
• Phone: +494074100
• Email: k.kouz[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: April 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypotension

Intervention

Other:
• Oscillometric blood pressure monitoring at 2.5-minute intervals
Oscillometric blood pressure will be measured at 2.5-minute intervals during surgery.
• Oscillometric blood pressure monitoring at 5-minute intervals
Oscillometric blood pressure will be measured at 5-minute intervals during surgery.

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Norepinephrine dose	Time-weighted cumulative amount of norepinephrine indexed to body weight [µg/kg/min].	Beginning of surgery until the end of surgery