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

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT01845506
Collaborator
Lauren Faught (Other), Michael Greff (Other), Michael Rieder (Other), Safieddin Safavi-Naeini (Other)
500
1
2
24
20.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cardiorespiratory monitor
  • Device: Wireless pressure sensor
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Application of a Wireless Sensor Technology for Vital Statistics in CHILDREN AND ADULTS
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Wireless pressure transducer

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.

Device: 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.

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital London Health Sciences Center London Ontario Canada N6A2V5

Sponsors and Collaborators

  • Lawson Health Research Institute
  • Lauren Faught
  • Michael Greff
  • Michael Rieder
  • Safieddin Safavi-Naeini

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Naveen Poonai, Assistant Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01845506
Other Study ID Numbers:
  • 2166
First Posted:
May 3, 2013
Last Update Posted:
Sep 3, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Naveen Poonai, Assistant Professor, Lawson Health Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 3, 2020