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

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

Sponsors

Lead Sponsor: Lawson Health Research Institute

Collaborator: Lauren Faught
Michael Greff
Michael Rieder
Safieddin Safavi-Naeini

Source Lawson Health Research Institute
Brief Summary

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.

Overall Status Not yet recruiting
Start Date 2021-12-01
Completion Date 2023-12-01
Primary Completion Date 2023-09-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The primary outcome is the level of agreement between cardiorespiratory monitor and sensor information for heart rate. 2 hours
Level of agreement between cardiorespiratory monitor and sensor information for blood pressure 2 hours
Level of agreement between cardiorespiratory monitor and sensor information for temperature 2 hours
Level of agreement between cardiorespiratory monitor and sensor information for oxygen saturation 2 hours
Enrollment 500
Condition
Intervention

Intervention Type: Device

Intervention Name: Cardiorespiratory monitor

Description: 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.

Arm Group Label: Cardiorespiratory Monitor

Intervention Type: Device

Intervention Name: Wireless pressure sensor

Description: 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.

Arm Group Label: Wireless pressure transducer

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: Naveen Poonai, MD

Phone: 5196858500

Phone Ext.: 52011

Email: [email protected]

Location
Facility: Contact: Children's Hospital London Health Sciences Center Naveen Poonai, MD 5196858500 52011 [email protected]
Location Countries

Canada

Verification Date

2020-09-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Lawson Health Research Institute

Investigator Full Name: Naveen Poonai

Investigator Title: Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Wireless pressure transducer

Type: Experimental

Description: 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.

Label: Cardiorespiratory Monitor

Type: Active Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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