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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04894019
Other study ID # 2020-10057-BO-ff
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 16, 2021
Est. completion date November 23, 2021

Study information

Verified date December 2021
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized trial (1) investigating whether continuous invasive arterial blood pressure monitoring using an arterial catheter reduces the area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction compared to intermittent arterial blood pressure monitoring using oscillometry in patients having major surgery under general anesthesia; and (2) investigating the effect of continuous invasive arterial blood pressure monitoring using an arterial catheter on cardiac output, stroke volume, and heart rate within the first 15 minutes of anesthetic induction compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having major surgery under general anesthesia.


Description:

not provided


Recruitment information / eligibility

Status Completed
Enrollment 242
Est. completion date November 23, 2021
Est. primary completion date November 23, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Patients... - at least 18 years of age - scheduled for elective major surgery under general anesthesia that requires continuous invasive arterial blood pressure monitoring using a radial arterial catheter for clinical indications not related to the study Exclusion Criteria: - Clinical indication to insert the arterial catheter before anesthetic induction ("awake arterial catheter"; this is usually the case in patients with severe cardiovascular diseases, such as heart failure or left ventricular assist device) - emergency surgery - American Society of Anesthesiologists physical status classification V or VI - need for femoral artery catheterization - heart rhythms other than sinus rhythm.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Continuous invasive blood pressure monitoring
Continuous invasive blood pressure monitoring using an arterial catheter
Intermittent non-invasive blood pressure monitoring
Intermittent non-invasive blood pressure monitoring using upper-arm cuff oscillometry

Locations

Country Name City State
Germany Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under a MAP of 65 mmHg within the first 15 minutes of anesthetic induction between the intervention and the control group. during the induction period
Secondary Effect of continuous invasive arterial blood pressure monitoring on cardiac output within the first 15 minutes of anesthetic induction between the intervention and the control group. during the induction period
Secondary Effect of continuous invasive arterial blood pressure monitoring on stroke volume within the first 15 minutes of anesthetic induction between the intervention and the control group. during the induction period
Secondary Effect of continuous invasive arterial blood pressure monitoring on heart rate within the first 15 minutes of anesthetic induction between the intervention and the control group. during the induction period
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