Clinical trial NCT06753097: Continuous Finger-cuff Arterial Pressure Monitoring and Intraoperative Hypotension During Non-cardiac Surgery: the Randomized DETECT II Trial
Official title: Continuous Finger-cuff Arterial Pressure Monitoring and Intraoperative Hypotension During Non-cardiac Surgery: the Randomized DETECT II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraoperative Hypotension
Keywords: finger-cuff
blood pressure
intraoperative hypotension
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 930
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: not provided

Eligibility criteria: 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)

Primary outcomes:
measure: Time-weighted average mean arterial pressure <65 mmHg
timeFrame: during the start of induction of general anesthesia until the end of surgery
Secondary outcomes:
measure: Time-weighted average mean arterial pressure <60 mmHg
timeFrame: during the start of induction of general anesthesia until the end of surgery
measure: Time-weighted average mean arterial pressure <50 mmHg
timeFrame: during the start of induction of general anesthesia until the end of surgery
measure: Time-weighted average mean arterial pressure <40 mmHg
timeFrame: during the start of induction of general anesthesia until the end of surgery
measure: Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <65 mmHg
timeFrame: during the start of induction of general anesthesia until the end of surgery
measure: Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <60 mmHg
timeFrame: during the start of induction of general anesthesia until the end of surgery
measure: Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <50 mmHg
timeFrame: during the start of induction of general anesthesia until the end of surgery
measure: Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <40 mmHg
timeFrame: during the start of induction of general anesthesia until the end of surgery
measure: Cumulative duration of a mean arterial pressure <65 mmHg
timeFrame: during the start of induction of general anesthesia until the end of surgery
measure: Time-weighted average mean arterial pressure >100 mmHg
timeFrame: during the start of induction of general anesthesia until the end of surgery
measure: Time-weighted average mean arterial pressure >110 mmHg
timeFrame: during the start of induction of general anesthesia until the end of surgery
measure: Time-weighted average mean arterial pressure >120 mmHg
timeFrame: during the start of induction of general anesthesia until the end of surgery
measure: Time-weighted average mean arterial pressure >140 mmHg
timeFrame: during the start of induction of general anesthesia until the end of surgery
Other outcomes:
measure: Acute kidney injury
timeFrame: Up until the first postoperative day
measure: Acute myocardial injury
timeFrame: Up until the first postoperative day
measure: Time-weighted average of the percentage decrease in regional cerebral oxygen saturation from the baseline
timeFrame: during the start of induction of general anesthesia until the end of surgery
measure: Incidence of cerebral hypoxia
timeFrame: during the start of induction of general anesthesia until the end of surgery
measure: Cumulative duration of cerebral hypoxia
timeFrame: during the start of induction of general anesthesia until the end of surgery
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
References: