Effect of Continuous Invasive Blood Pressure Monitoring on Postinduction Hypotension in Patients Having Major Surgery

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Perioperative Hypotension; Postinduction Hypotension; Blood Pressure

Treatments: Device: Continuous invasive blood pressure monitoring; Device: Intermittent non-invasive blood pressure monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT04894019

2020-10057-BO-ff

Details and patient eligibility

About

This is a randomized trial (1) investigating whether continuous invasive arterial blood pressure monitoring using an arterial catheter reduces the area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction compared to intermittent arterial blood pressure monitoring using oscillometry in patients having major surgery under general anesthesia; and (2) investigating the effect of continuous invasive arterial blood pressure monitoring using an arterial catheter on cardiac output, stroke volume, and heart rate within the first 15 minutes of anesthetic induction compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having major surgery under general anesthesia.

Full description

not provided

Enrollment: 242 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients...

• at least 18 years of age
• scheduled for elective major surgery under general anesthesia that requires continuous invasive arterial blood pressure monitoring using a radial arterial catheter for clinical indications not related to the study

Exclusion criteria

• Clinical indication to insert the arterial catheter before anesthetic induction ("awake arterial catheter"; this is usually the case in patients with severe cardiovascular diseases, such as heart failure or left ventricular assist device)
• emergency surgery
• American Society of Anesthesiologists physical status classification V or VI
• need for femoral artery catheterization
• heart rhythms other than sinus rhythm.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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242 participants in 2 patient groups

Continuous monitoring group

Experimental group

Description:

In patients randomized to the continuous monitoring group, continuous invasive arterial blood pressure monitoring will be displayed on the patient monitor. The treating anesthesiologist will be blinded to intermittent blood pressure monitoring using upper-arm cuff oscillometry.

Treatment:

Device: Continuous invasive blood pressure monitoring

Intermittent monitoring group

Active Comparator group

Description:

In patients randomized to the intermittent monitoring group, intermittent blood pressure monitoring will be displayed on the patient monitor. The treating anesthesiologist is blinded to continuous invasive arterial blood pressure monitoring.

Treatment:

Device: Intermittent non-invasive blood pressure monitoring