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

NCT ID: NCT04894019

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-16

Study Completion Date

2021-11-23

Brief Summary

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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

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not provided

Conditions

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Blood Pressure Perioperative Hypotension Postinduction Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Continuous monitoring group

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.

Group Type EXPERIMENTAL

Continuous invasive blood pressure monitoring

Intervention Type DEVICE

Continuous invasive blood pressure monitoring using an arterial catheter

Intermittent monitoring group

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.

Group Type ACTIVE_COMPARATOR

Intermittent non-invasive blood pressure monitoring

Intervention Type DEVICE

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

Interventions

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Continuous invasive blood pressure monitoring

Continuous invasive blood pressure monitoring using an arterial catheter

Intervention Type DEVICE

Intermittent non-invasive blood pressure monitoring

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Hamburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 36008202 (View on PubMed)

Other Identifiers

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2020-10057-BO-ff

Identifier Type: -

Identifier Source: org_study_id