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

Not Applicable

Completed

• Conditions: Blood Pressure; Perioperative Hypotension; Postinduction Hypotension
• Interventions: Device: Continuous invasive blood pressure monitoring; Device: Intermittent non-invasive blood pressure monitoring

• Registration Number: NCT04894019
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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.

Detailed Description

not provided

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-15
• Study Start: 2021-05-16
• Study First Posted: 2021-05-20
• Primary Completion: 2021-11-23
• Study Completion: 2021-11-23
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous monitoring group	Continuous invasive blood pressure monitoring	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.
Intermittent monitoring group	Intermittent non-invasive blood pressure monitoring	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.

Primary Outcome Measures

Name	Time	Method
Area under a MAP of 65 mmHg within the first 15 minutes of anesthetic induction between the intervention and the control group.	during the induction period

Secondary Outcome Measures

Name	Time	Method
Effect of continuous invasive arterial blood pressure monitoring on cardiac output within the first 15 minutes of anesthetic induction between the intervention and the control group.	during the induction period
Effect of continuous invasive arterial blood pressure monitoring on heart rate within the first 15 minutes of anesthetic induction between the intervention and the control group.	during the induction period
Effect of continuous invasive arterial blood pressure monitoring on stroke volume within the first 15 minutes of anesthetic induction between the intervention and the control group.	during the induction period

Trial Locations

Locations (1)

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany