The Application of a Wireless Sensor Technology for Vital Statistics in CHILDREN AND ADULTS

Study Overview
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Brief Summary
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The primary outcome for this project will be the development of a small, non-invasive wireless sensor that is linked to a conventional computer that can be used in health care for monitoring of acute and chronic health problems. The advantages of developing this technology are threefold. First, monitoring can be conducted for a fraction of the cost of a bedside nurse. Second, monitoring can be done in real time and stored so that we can diagnose and manage critical events in a more timely manner. Lastly, many patients can be monitored simultaneously. The wireless sensors will be fitted to healthy volunteers of various ages. The data gathered from the sensor with respect to their vital signs will be compared to that of conventional tools such as nursing assessments and pulse oximetry.

Official Title
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The Application of a Wireless Sensor Technology for Vital Statistics in CHILDREN AND ADULTS

Conditions
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Fever, COPD, Obesity, Congenital Heart Disease, Respiratory Distress

Intervention / Treatment
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* Device: Cardiorespiratory monitor
* Device: Wireless pressure sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with controlled and non-controlled hypertension (hypertension defined as > 130/90 on two separate occasions and history of hypertension) Adults with known chronic obstructive pulmonary disease in respiratory distress with oxygen saturations < 90% Febrile adults (temp at triage > 38 C) with no significant co-morbidities Elderly (>70 years) patients with no significant co-morbidities Obese adults (BMI > 30) Febrile (temp at triage > 38 C) and non-febrile children (age < 18 yrs) Obese children (BMI > 30) Neonates (age < 6 weeks) Children with corrected cyanotic congenital heart disease Children in respiratory distress that present with oxygen saturations < 90% Exclusion Criteria: -Subjects with unstable vital signs will be excluded.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wireless pressure transducer<br>Following informed consent, each subject will be fitted with a wireless sensor attached to a conventional laptop computer. The sensors fit around the participant's chest and work as transducers. | Device: Wireless pressure sensor<br>* Following informed consent, each subject will be fitted with a wireless sensor attached to a conventional laptop computer. The sensors fit around the participant's chest and work as transducers.<br>|
| Active Comparator: Cardiorespiratory Monitor<br>Following informed consent, each subject will be also be fitted with ECG leads (five), and an oxygen saturation monitor. This information as well as blood pressure and temperature will be recorded at 5-minute intervals by a nurse. | Device: Cardiorespiratory monitor<br>* Subjects will also be fitted with conventional monitoring devices as per the standard of care (3 or 5 lead ECG, pulse oximeter, blood pressure cuff) and will have vital statistics obtained by a trained research assistant at regular 5-minute intervals including blood pressure, heart rate, temperature, and respiratory rate using the standard cardiorespiratory bedside monitor's cycling protocol. The same parameters will be obtained from the wireless sensor at identical time points for a duration of 2 hours. Data obtained from both conventional and study sources will be entered into an encrypted USB device for later analysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is the level of agreement between cardiorespiratory monitor and sensor information for heart rate. | The primary outcome is the level of agreement between conventional methods and sensor information for heart rate. | 2 hours | 
| Level of agreement between cardiorespiratory monitor and sensor information for blood pressure | The primary outcome is the level of agreement between conventional methods and sensor information for blood pressure. | 2 hours | 
| Level of agreement between cardiorespiratory monitor and sensor information for temperature | The primary outcome is the level of agreement between conventional methods and sensor information for temperature. | 2 hours | 
| Level of agreement between cardiorespiratory monitor and sensor information for oxygen saturation | The primary outcome is the level of agreement between conventional methods and sensor information for oxygen saturation. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wireless pressure sensor, Elderly