Effects of Continuous Noninvasive Arterial Pressure Measurement on Anaesthesia

Blood Pressure Stability in General Anaesthesia Clinical Trial

— ANIKOB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519101
• Other study ID #: 290-15
• Status: Completed
• Phase: N/A
• First received: August 1, 2015
• Last updated: August 29, 2017
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: August 2017
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure Stability in General Anaesthesia

Intervention

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

Locations

Country	Name	City	State
Germany	Klinik für Anaesthesiologie am Klinikum der Universität München	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mean arterial blood pressure		consecutive full hours of general anaesthesia (estimated average 3 hours)
Primary	Number of Patients with Hypotensive Events in comparison between both groups		During induction and maintainance of general anaesthesia (average estimated time = 3 hours)
Primary	Dosage of Norepinephrine given to the patient to maintain blood pressure normotensive		During induction and maintainance of general anaesthesia (average estimated time = 3 hours)
Secondary	Incidence of acute kidney failure postoperatively		during hospital stay after surgical procedure (in average 3 days)