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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02519101
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Stephan Czerner, Ludwig-Maximilians - University of Munich

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

Condition or disease Intervention/treatment Phase
Blood Pressure Stability in General Anaesthesia Device: continuous noninvasive blood pressure monitoring ClearSight-Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Impact of Continuous Noninvasive Arterial Blood Pressure Monitoring on Blood Pressure Stability During General Anaesthesia in Orthopedic Patients
Study Start Date : June 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

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 Name: ClearSight-Device (Edwards)

No Intervention: Intermittent blood pressure monitoring
Control group with intermittent blood pressure monitoring



Primary Outcome Measures :
  1. 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) ]
  2. 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) ]

Secondary Outcome Measures :
  1. Incidence of acute kidney failure postoperatively [ Time Frame: during hospital stay after surgical procedure (in average 3 days) ]

Other Outcome Measures:
  1. mean arterial blood pressure [ Time Frame: consecutive full hours of general anaesthesia (estimated average 3 hours) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519101


Locations
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Germany
Klinik für Anaesthesiologie am Klinikum der Universität München
Munich, Bavaria, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Stephan Czerner, Senior Physician, Department of Anaesthesiology, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT02519101    
Other Study ID Numbers: 290-15
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017