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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ We will include three types of patients:

• Patients scheduled for ambulatory (outpatient) elective non-cardiac surgery expected to last ≥30 minutes

• Low-risk patients (ASA I+II) having inpatient elective non-cardiac surgery expected to last ≥60 minutes

• Moderate-risk patients (ASA III) having inpatient elective non-cardiac surgery expected to last ≥60 minutes

⁃ We will only include patients who are 18 years or older; who will have general anesthesia; and in whom intermittent arterial pressure monitoring with upper-arm cuff oscillometry is planned.

Locations
Other Locations
Germany
University Medical Center Hamburg-Eppendorf
RECRUITING
Hamburg
Contact Information
Primary
Bernd Saugel, MD
b.saugel@uke.de
+49741052415
Backup
Karim Kouz, MD
k.kouz@uke.de
+49741052415
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2026-02
Participants
Target number of participants: 930
Treatments
No_intervention: Intermittent oscillometric arterial pressure monitoring
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.
Experimental: Continuous finger-cuff arterial pressure monitoring
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.
Related Therapeutic Areas
Sponsors
Leads: Universitätsklinikum Hamburg-Eppendorf

This content was sourced from clinicaltrials.gov