Effects of Continuous Noninvasive Arterial Pressure Measurement on Anaesthesia (ANIKOB)

August 29, 2017 updated by: Dr. Stephan Czerner, Ludwig-Maximilians - University of Munich

Impact of Continuous Noninvasive Arterial Blood Pressure Monitoring on Blood Pressure Stability During General Anaesthesia in Orthopedic Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Klinik für Anaesthesiologie am Klinikum der Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continunous blood pressure monitoring
Patients receive continuous noninvasive blood pressure monitoring in addition to intermittent monitoring
Device: continuous noninvasive blood pressure monitoring ClearSight-Device
Noninvasive continuous blood pressure monitoring using the volume clamp method (ClearSight-Device)
Other Names:
  • ClearSight-Device (Edwards)
No Intervention: Intermittent blood pressure monitoring
Control group with intermittent blood pressure monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients with Hypotensive Events in comparison between both groups
Time Frame: During induction and maintainance of general anaesthesia (average estimated time = 3 hours)
During induction and maintainance of general anaesthesia (average estimated time = 3 hours)
Dosage of Norepinephrine given to the patient to maintain blood pressure normotensive
Time Frame: During induction and maintainance of general anaesthesia (average estimated time = 3 hours)
During induction and maintainance of general anaesthesia (average estimated time = 3 hours)

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of acute kidney failure postoperatively
Time Frame: during hospital stay after surgical procedure (in average 3 days)
during hospital stay after surgical procedure (in average 3 days)

Other Outcome Measures

Outcome Measure
Time Frame
mean arterial blood pressure
Time Frame: consecutive full hours of general anaesthesia (estimated average 3 hours)
consecutive full hours of general anaesthesia (estimated average 3 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

August 1, 2015

First Submitted That Met QC Criteria

August 7, 2015

First Posted (Estimate)

August 10, 2015

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 290-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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