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

Study Overview
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Brief Summary
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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.

Detailed Description
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not provided

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

Conditions
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Blood Pressure, Perioperative Hypotension, Postinduction Hypotension

Intervention / Treatment
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* Device: Continuous invasive blood pressure monitoring
* Device: Intermittent non-invasive blood pressure monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous monitoring group<br>In patients randomized to the continuous monitoring group, continuous invasive arterial blood pressure monitoring will be displayed on the patient monitor. The treating anesthesiologist will be blinded to intermittent blood pressure monitoring using upper-arm cuff oscillometry. | Device: Continuous invasive blood pressure monitoring<br>* Continuous invasive blood pressure monitoring using an arterial catheter<br>|
| Active Comparator: Intermittent monitoring group<br>In patients randomized to the intermittent monitoring group, intermittent blood pressure monitoring will be displayed on the patient monitor. The treating anesthesiologist is blinded to continuous invasive arterial blood pressure monitoring. | Device: Intermittent non-invasive blood pressure monitoring<br>* Intermittent non-invasive blood pressure monitoring using upper-arm cuff oscillometry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |