Continuous Finger-cuff Arterial Pressure Monitoring and Intraoperative Hypotension During Non-cardiac Surgery: the Randomized DETECT II Trial

NCT06753097 | Completed

• 1 other identifier: 2024-101349-BO-ff
• Study Type: interventional
• Target: 930
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized trial (1) investigating whether continuous finger-cuff - compared to intermittent oscillometric - arterial pressure monitoring reduces the amount of intraoperative hypotension (specifically, from the start of induction of general anesthesia until the end of surgery) in low-to-moderate risk patients having elective non-cardiac surgery.

Conditions

Intraoperative Hypotension

Keywords

finger-cuff; blood pressure; intraoperative hypotension

Outcome Measures

Primary Outcomes (1)

• Time-weighted average mean arterial pressure <65 mmHg

  during the start of induction of general anesthesia until the end of surgery

Secondary Outcomes (12)

• Time-weighted average mean arterial pressure <60 mmHg

  during the start of induction of general anesthesia until the end of surgery

• Time-weighted average mean arterial pressure <50 mmHg

  during the start of induction of general anesthesia until the end of surgery

• Time-weighted average mean arterial pressure <40 mmHg

  during the start of induction of general anesthesia until the end of surgery

• Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <65 mmHg

  during the start of induction of general anesthesia until the end of surgery

• Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <60 mmHg

  during the start of induction of general anesthesia until the end of surgery

Other Outcomes (5)

• Acute kidney injury

  Up until the first postoperative day

• Acute myocardial injury

  Up until the first postoperative day

• Time-weighted average of the percentage decrease in regional cerebral oxygen saturation from the baseline

  during the start of induction of general anesthesia until the end of surgery

Study Arms (2)

Intermittent oscillometric arterial pressure monitoring

NO INTERVENTION

In patients assigned to intermittent oscillometric arterial pressure monitoring, oscillometric arterial pressure measurements will be displayed on the patient monitor and the treating anesthesiologist will be blinded to continuous finger-cuff arterial pressure monitoring. Oscillometric arterial pressure monitoring will be performed in 2.5 minutes intervals, but clinicians are free to perform additional measurements at any time.

Continuous finger-cuff arterial pressure monitoring

EXPERIMENTAL

In patients assigned to continuous finger-cuff arterial pressure monitoring, arterial pressure waveforms and measurements from the finger-cuff will be displayed on the patient monitor and treating anesthesiologists will be blinded to intermittent oscillometric arterial pressure monitoring.

Device: Continuous finger-cuff arterial pressure monitoring

Interventions

Continuous finger-cuff arterial pressure monitoring DEVICE

Arterial pressure will be monitored using continuous non-invasive finger-cuff arterial pressure monitoring.

Continuous finger-cuff arterial pressure monitoring

Eligibility Criteria

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

You may not qualify if:

• Emergency surgery
• Patients on renal replacement therapy
• Contraindications for finger-cuff monitoring (e.g., Raynaud disease)

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

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: MD

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: December 31, 2024
• Study Start: January 6, 2025
• Primary Completion: February 19, 2026
• Study Completion: February 19, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)