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

Universitätsklinikum Hamburg-Eppendorf

Status: Enrolling

Conditions: Intraoperative Hypotension

Treatments: Device: Continuous finger-cuff arterial pressure monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06753097

2024-101349-BO-ff

Details and patient eligibility

About

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.

Full description

not provided

Enrollment: 930 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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930 participants in 2 patient groups

Intermittent oscillometric arterial pressure monitoring

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: Continuous finger-cuff arterial pressure monitoring