Skip to main content
OpenTrials
Completed

NCT Number: NCT06314074

2.5 Versus 5 Minutes 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 5-minute intervals

Other

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

Primary outcomes

  1. Time-weighted average mean arterial pressure <65 mmHg

    Time frame: 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 outcomes

  1. Episodes of a mean arterial pressure <50 mmHg

    Time frame: 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.

  2. Norepinephrine dose

    Time frame: Beginning of surgery until the end of surgery

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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.