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

NCT04894019 | Completed

• 1 other identifier: 2020-10057-BO-ff
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Perioperative Hypotension; Postinduction Hypotension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 stroke volume 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

Study Arms (2)

Continuous monitoring group

EXPERIMENTAL

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.

Device: Continuous invasive blood pressure monitoring

Intermittent monitoring group

ACTIVE COMPARATOR

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.

Device: Intermittent non-invasive blood pressure monitoring

Interventions

Continuous invasive blood pressure monitoring DEVICE

Continuous invasive blood pressure monitoring using an arterial catheter

Continuous monitoring group

Intermittent non-invasive blood pressure monitoring DEVICE

Intermittent non-invasive blood pressure monitoring using upper-arm cuff oscillometry

Intermittent monitoring group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

• Kouz K, Wegge M, Flick M, Bergholz A, Moll-Khosrawi P, Nitzschke R, Trepte CJC, Krause L, Sessler DI, Zollner C, Saugel B. Continuous intra-arterial versus intermittent oscillometric arterial pressure monitoring and hypotension during induction of anaesthesia: the AWAKE randomised trial. Br J Anaesth. 2022 Oct;129(4):478-486. doi: 10.1016/j.bja.2022.06.027. Epub 2022 Aug 23.

  PMID: 36008202 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 20, 2021
• Study Start: May 16, 2021
• Primary Completion: November 23, 2021
• Study Completion: November 23, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)