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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01845506
Enrollment
500
Registered
2013-05-03
Start date
2021-12-31
Completion date
2023-12-31
Last updated
2020-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

wireless pressure sensor, Elderly

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.

Interventions

DEVICECardiorespiratory 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.

DEVICEWireless 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.

Sponsors

Lauren Faught
CollaboratorUNKNOWN
Michael Greff
CollaboratorUNKNOWN
Michael Rieder
CollaboratorUNKNOWN
Safieddin Safavi-Naeini
CollaboratorUNKNOWN
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome is the level of agreement between cardiorespiratory monitor and sensor information for heart rate.2 hoursThe 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 blood pressure2 hoursThe primary outcome is the level of agreement between conventional methods and sensor information for blood pressure.
Level of agreement between cardiorespiratory monitor and sensor information for temperature2 hoursThe 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 oxygen saturation2 hoursThe primary outcome is the level of agreement between conventional methods and sensor information for oxygen saturation.

Countries

Canada

Contacts

Primary ContactNaveen Poonai, MD
poonai@hotmail.com5196858500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026