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

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.

Study Overview

• Status: Completed
• Conditions: Intraoperative Hypotension
• Intervention / Treatment: Device: Continuous finger-cuff arterial pressure monitoring

Detailed Description

not provided

• Study Type: Interventional
• Enrollment (Actual): 930
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

We will include three types of patients:

1. Patients scheduled for ambulatory (outpatient) elective non-cardiac surgery expected to last ≥30 minutes
2. Low-risk patients (ASA I+II) having inpatient elective non-cardiac surgery expected to last ≥60 minutes
3. 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.

Patients that meet one or more of the following exclusion criteria cannot participate in the trial:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Continuous finger-cuff arterial pressure monitoring; Arterial pressure will be monitored using continuous non-invasive finger-cuff arterial pressure monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time-weighted average mean arterial pressure <65 mmHg	during the start of induction of general anesthesia until the end of surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <50 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 <40 mmHg	during the start of induction of general anesthesia until the end of surgery
Cumulative duration of a mean arterial pressure <65 mmHg	during the start of induction of general anesthesia until the end of surgery
Time-weighted average mean arterial pressure >100 mmHg	during the start of induction of general anesthesia until the end of surgery
Time-weighted average mean arterial pressure >110 mmHg	during the start of induction of general anesthesia until the end of surgery
Time-weighted average mean arterial pressure >120 mmHg	during the start of induction of general anesthesia until the end of surgery
Time-weighted average mean arterial pressure >140 mmHg	during the start of induction of general anesthesia until the end of surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute kidney injury	Acute kidney injury (binary outcome) will be defined as an increase in postoperative serum creatinine from baseline of at least 0.3 mg/dl or ≥50%.	Up until the first postoperative day
Acute myocardial injury	Acute myocardial injury (binary outcome) will be defined based on the definition of "myocardial injury and infarction associated with non-cardiac procedures" according to the Fourth Universal Definition of Myocardial Infarction (2018)	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
Incidence of cerebral hypoxia	Cerebral hypoxia will be defined as a regional cerebral oxygen saturation (rcSO2) <50% or a decrease in rcSO2 >20% from baseline (if the baseline was ≥50%) or a decrease in rcSO2 >15% from baseline (if the baseline was <50%).	during the start of induction of general anesthesia until the end of surgery
Cumulative duration of cerebral hypoxia	Cerebral hypoxia will be defined as a regional cerebral oxygen saturation (rcSO2) <50% or a decrease in rcSO2 >20% from baseline (if the baseline was ≥50%) or a decrease in rcSO2 >15% from baseline (if the baseline was <50%).	during the start of induction of general anesthesia until the end of surgery

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Actual): February 19, 2026
• Study Completion (Actual): February 19, 2026

Study Registration Dates

• First Submitted: December 21, 2024
• First Submitted That Met QC Criteria: December 21, 2024
• First Posted (Actual): December 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: blood pressure; intraoperative hypotension; finger-cuff
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension
• Other Study ID Numbers: 2024-101349-BO-ff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No