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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01845506
• Other study ID #: 2166
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2021
• Est. completion date: December 2023

Study information

• Verified date: September 2020
• Source: Lawson Health Research Institute
• Contact: Naveen Poonai, MD
• Phone: 5196858500
• Email: poonai[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• COPD
• Fever
• Heart Diseases
• Obesity
• Respiratory Distress

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Children's Hospital London Health Sciences Center	London	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Lauren Faught, Michael Greff, Michael Rieder, Safieddin Safavi-Naeini

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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