Agreement Between Standard and Continuous Wireless Vital Sign Measurements

Study Overview
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Brief Summary
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Patients undergoing major surgery are at risk of postoperative complications. Continuous wireless monitoring outside the post-anesthesia or intensive care units may enable early detection of patient deterioration, but good accuracy of measurements is required. This validation study, which is part of the WARD-SX project, aimed to assess the agreement between vital signs recorded by standard and novel wireless devices

Detailed Description
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Patients undergoing major surgery are at risk of postoperative complications. Complications may be preceded by abnormal vital signs. Standard monitoring at general wards is intermittent and manual, leaving the patients unobserved for extended periods. The chance to enhance monitoring has arisen with recent technological advances in the form of small wearable and wireless devices that continuously record vital signs. Wearable devices enable continuous monitoring outside the intensive care unit and post-anesthesia care unit, thus enabling early detection of patient deterioration. However, before implementing such devices in hospital settings, good accuracy, and precision of measurements is required. This validation study, which is part of the WARD-SX project, aimed to assess the agreement between vital signs recorded by standard and novel wireless devices

Official Title
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Agreement Between Standard and Continuous Wireless Vital Sign Measurements Following Major Abdominal Surgery: A Clinical Comparison Study

Conditions
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Postoperative Patients

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥60 years, scheduled for major abdominal cancer surgery with planned PACU admission. Estimated surgical intervention duration ≥2 hours. Exclusion Criteria: Implanted cardioverter defibrillator or pacemaker, allergy to study devices, severe cognitive impairment assessed by Mini-Mental State Examination ≤24, or inability to cooperate in wearing the wireless monitoring equipment.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 110 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Device: Continuous monitoring system<br>Continuous monitoring system Recruited patients will be continuously monitored with Isansys Lifetouch patch, Nonin WristOx 3150, Isansys wireless blood pressure monitor (Meditech Blue BP-05) and standard monitoring at the post anesthesia care unit | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate comparisons | Heart rate (beats per minute) measurements compared between Isansys Lifetouch and standard monitoring (Phillips IntelliVue). Analysed using Bland Altman (BA) analysis to measure mean diference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject. | 1.5 hours (measurement interval every 15 min) | 
| Respiratory rate comparisons | Respiratory rate (breaths per minute) measurements compared between Isansys Lifetouch and observed counted measurements. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject. | 1.5 hours | 
| SpO2 measurements comparisons wireless vs. standard | SpO2 (percent) measurements compared between Nonin WristOx 3150 and standard monitoring. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject. | 1.5 hours (measurement interval every 15 min) | 
| SpO2 measurements comparisons wireless vs. invasive | SpO2 (percent) measurements compared between Nonin WristOx 3150 and arterial arterial oxygen saturation. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject. | 1.5 hours | 
| Pulse rate comparisons | Pulse rate measurements (beats per minute) measures compared between Nonin WristOx 3150 and standard monitoring. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject. | 1.5 hours | 
| Blood pressure comparisons wireless vs. standard | Blood pressure (mmHg) measurements compared between Meditech BlueBp-05 and standard monitoring. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject. | 1.5 hours, every 15 min | 
| Blood pressure comparisons, wireless vs. arterial BP | Systolic and diastolic (mmHg) measurements compared between Meditech BlueBp-05 and invasive arterial blood pressure. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject. | 1.5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wearable devices, continuous, comparison study, validation