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

Not Applicable

• Conditions: Fever; COPD; Congenital Heart Disease; Obesity; Respiratory Distress
• Interventions: Device: Wireless pressure sensor; Device: Cardiorespiratory monitor

• Registration Number: NCT01845506
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-25
• Study First Submitted QC: 2013-05-01
• Study First Posted: 2013-05-03
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-03
• Study Start: 2021-12
• Primary Completion: 2023-09
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wireless pressure transducer	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.
Cardiorespiratory Monitor	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.

Primary Outcome Measures

Name	Time	Method
Level of agreement between cardiorespiratory monitor and sensor information for temperature	2 hours	The primary outcome is the level of agreement between conventional methods and sensor information for temperature.
Level of agreement between cardiorespiratory monitor and sensor information for blood pressure	2 hours	The primary outcome is the level of agreement between conventional methods and sensor information for blood pressure.
The primary outcome is the level of agreement between cardiorespiratory monitor and sensor information for heart rate.	2 hours	The primary outcome is the level of agreement between conventional methods and sensor information for heart rate.
Level of agreement between cardiorespiratory monitor and sensor information for oxygen saturation	2 hours	The primary outcome is the level of agreement between conventional methods and sensor information for oxygen saturation.

Trial Locations

Locations (1)

Children's Hospital London Health Sciences Center; 🇨🇦 London, Ontario, Canada