Impact of Continuous Non-invasive Blood Pressure Monitoring on Hypotension in Patients Having Non-cardiac Surgery

Not Applicable

Completed

• Conditions: Perioperative Hypotension; Blood Pressure
• Interventions: Device: Continuous non-invasive blood pressure monitoring; Device: Intermittent non-invasive blood pressure monitoring

• Registration Number: NCT04736862
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

This is a randomized trial (1) investigating whether continuous non-invasive finger-cuff blood pressure monitoring reduces the area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having non-cardiac surgery; and (2) investigating whether continuous non-invasive finger-cuff blood pressure monitoring reduces the time-weighted average for MAP \<65 mmHg during the intraoperative period compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having non-cardiac surgery.

Detailed Description

not provided

Study Timeline

• Study First Submitted: 2021-01-31
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-03
• Study Start: 2021-03-23
• Status Verified: 2021-10
• Primary Completion: 2021-10-06
• Study Completion: 2021-10-06
• Last Update Submitted: 2021-10-11
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

• Patients at least 45 years of age scheduled for elective non-cardiac surgery with general anesthesia are eligible for study inclusion if blood pressure monitoring using intermittent upper-arm cuff oscillometry is planned.

Exclusion Criteria

• Emergency surgery,
• pregnancy,
• American Society of Anesthesiologists (ASA) physical status classification V or VI, blood pressure differences between the right and left arm of more than 20 mmHg, intraoperative invasive blood pressure monitoring, heart rhythms other than sinus rhythm.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous monitoring group	Continuous non-invasive blood pressure monitoring	-
Intermittent monitoring group	Intermittent non-invasive blood pressure monitoring	-

Primary Outcome Measures

Name	Time	Method
Area under a MAP of 65 mmHg within the first 15 minutes of anesthetic induction between the intervention and the control group.	15 min
Time-weighted average for MAP <65 mmHg during the intraoperative period between the intervention and the control group.	intraoperative

Trial Locations

Locations (1)

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany