Effect of Continuous Invasive Blood Pressure Monitoring on Postinduction Hypotension in Patients Having Major Surgery

Blood Pressure Clinical Trial

Official title:

The Effect of Continuous Invasive Arterial Blood Pressure Monitoring on Postinduction Hypotension in Patients Having Major Surgery (AWAKE Trial): a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04894019
• Other study ID #: 2020-10057-BO-ff
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Blood Pressure
• Hypotension
• Perioperative Hypotension

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