Impact of Continuous Non-invasive Blood Pressure Monitoring on Hypotension in Patients Having Non-cardiac Surgery

Study Overview
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Brief Summary
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This is a randomized trial (1) investigating whether continuous non-invasive finger-cuff blood pressure monitoring reduces the area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having non-cardiac surgery; and (2) investigating whether continuous non-invasive finger-cuff blood pressure monitoring reduces the time-weighted average for MAP <65 mmHg during the intraoperative period compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having non-cardiac surgery.

Detailed Description
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not provided

Official Title
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The Impact of Continuous Non-invasive Blood Pressure Monitoring on Post-induction and Intraoperative Hypotension in Patients Having Non-cardiac Surgery (DETECT Trial): A Randomized Trial

Conditions
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Blood Pressure, Perioperative Hypotension

Intervention / Treatment
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* Device: Continuous non-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 45 years of age scheduled for elective non-cardiac surgery with general anesthesia are eligible for study inclusion if blood pressure monitoring using intermittent upper-arm cuff oscillometry is planned. Exclusion Criteria: Emergency surgery, pregnancy, American Society of Anesthesiologists (ASA) physical status classification V or VI, blood pressure differences between the right and left arm of more than 20 mmHg, intraoperative invasive blood pressure monitoring, heart rhythms other than sinus rhythm.

Ages Eligible for Study
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Minimum Age: 45 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> | Device: Continuous non-invasive blood pressure monitoring<br>* In patients randomized to the continuous monitoring group, continuous non-invasive finger-cuff 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.<br>|
| Active Comparator: Intermittent monitoring group<br> | Device: Intermittent non-invasive blood pressure monitoring<br>* In patients randomized to the intermittent monitoring group, intermittent blood pressure monitoring using upper-arm cuff oscillometry will be displayed on the patient monitor. The treating anesthesiologist is blinded to continuous non-invasive finger-cuff blood pressure monitoring.<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. |  | 15 min | 
| Time-weighted average for MAP <65 mmHg during the intraoperative period between the intervention and the control group. |  | intraoperative |