Effects of Continuous Noninvasive Arterial Pressure Measurement on Anaesthesia

NCT ID: NCT02519101

Last Updated: 2017-08-30

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-05-31

Brief Summary

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Continuous noninvasive blood pressure monitoring may help to avoid intraoperative Hypotension or Hypertension

Detailed Description

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Conditions

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Blood Pressure Stability in General Anaesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Continunous blood pressure monitoring

Patients receive continuous noninvasive blood pressure monitoring in addition to intermittent monitoring

Group Type EXPERIMENTAL

continuous noninvasive blood pressure monitoring ClearSight-Device

Intervention Type DEVICE

Noninvasive continuous blood pressure monitoring using the volume clamp method (ClearSight-Device)

Intermittent blood pressure monitoring

Control group with intermittent blood pressure monitoring

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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continuous noninvasive blood pressure monitoring ClearSight-Device

Noninvasive continuous blood pressure monitoring using the volume clamp method (ClearSight-Device)

Intervention Type DEVICE

Other Intervention Names

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ClearSight-Device (Edwards)

Eligibility Criteria

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Inclusion Criteria

* orthopedic surgery in general anaesthesia
* American Society of Anesthesiologists - Physical Status (ASA) 2 or ASA 3
* arterial Hypertension

Exclusion Criteria

-invasive blood pressure monitoring required
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Dr. Stephan Czerner

Senior Physician, Department of Anaesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Klinik für Anaesthesiologie am Klinikum der Universität München

Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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Meidert AS, Nold JS, Hornung R, Paulus AC, Zwissler B, Czerner S. The impact of continuous non-invasive arterial blood pressure monitoring on blood pressure stability during general anaesthesia in orthopaedic patients: A randomised trial. Eur J Anaesthesiol. 2017 Nov;34(11):716-722. doi: 10.1097/EJA.0000000000000690.

Reference Type DERIVED
PMID: 28922340 (View on PubMed)

Other Identifiers

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290-15

Identifier Type: -

Identifier Source: org_study_id

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