- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02519101
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
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
-
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Bavaria
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Munich, Bavaria, Germany, 81377
- Klinik für Anaesthesiologie am Klinikum der Universität München
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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
|
Noninvasive continuous blood pressure monitoring using the volume clamp method (ClearSight-Device)
Other Names:
|
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)
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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)
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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.
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.
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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