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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2023-12-31

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.

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Detailed Description

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Conditions

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Fever COPD Obesity Congenital Heart Disease Respiratory Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Wireless pressure transducer

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.

Group Type EXPERIMENTAL

Wireless pressure sensor

Intervention Type DEVICE

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.

Cardiorespiratory Monitor

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.

Group Type ACTIVE_COMPARATOR

Cardiorespiratory monitor

Intervention Type DEVICE

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.

Interventions

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Cardiorespiratory monitor

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.

Intervention Type DEVICE

Wireless pressure sensor

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.

Intervention Type DEVICE

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%