The Application of a Wireless Sensor Technology for Vital Statistics in CHILDREN AND ADULTS
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2013
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedSeptember 3, 2020
September 1, 2020
1.8 years
April 25, 2013
September 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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
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
Study Arms (2)
Wireless pressure transducer
EXPERIMENTALFollowing 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
ACTIVE COMPARATORFollowing 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- Subjects with unstable vital signs will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'slead
- Lauren Faughtcollaborator
- Michael Greffcollaborator
- Michael Riedercollaborator
- Safieddin Safavi-Naeinicollaborator
Study Sites (1)
Children's Hospital London Health Sciences Center
London, Ontario, N6A2V5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 25, 2013
First Posted
May 3, 2013
Study Start
December 1, 2021
Primary Completion
September 1, 2023
Study Completion
December 1, 2023
Last Updated
September 3, 2020
Record last verified: 2020-09