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

Primary Purpose

Fever, COPD, Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cardiorespiratory monitor
Wireless pressure sensor
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fever focused on measuring wireless pressure sensor, Elderly

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Children's Hospital London Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wireless pressure transducer

Cardiorespiratory Monitor

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 25, 2013
Last Updated
September 1, 2020
Sponsor
Lawson Health Research Institute
Collaborators
Lauren Faught, Michael Greff, Michael Rieder, Safieddin Safavi-Naeini
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1. Study Identification

Unique Protocol Identification Number
NCT01845506
Brief Title
The Application of a Wireless Sensor Technology for Vital Statistics in CHILDREN AND ADULTS
Official Title
The Application of a Wireless Sensor Technology for Vital Statistics in CHILDREN AND ADULTS
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Lauren Faught, Michael Greff, Michael Rieder, Safieddin Safavi-Naeini

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, COPD, Obesity, Congenital Heart Disease, Respiratory Distress
Keywords
wireless pressure sensor, Elderly

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wireless pressure transducer
Arm Type
Experimental
Arm Description
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.
Arm Title
Cardiorespiratory Monitor
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cardiorespiratory monitor
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Wireless pressure sensor
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome is the level of agreement between cardiorespiratory monitor and sensor information for heart rate.
Description
The primary outcome is the level of agreement between conventional methods and sensor information for heart rate.
Time Frame
2 hours
Title
Level of agreement between cardiorespiratory monitor and sensor information for blood pressure
Description
The primary outcome is the level of agreement between conventional methods and sensor information for blood pressure.
Time Frame
2 hours
Title
Level of agreement between cardiorespiratory monitor and sensor information for temperature
Description
The primary outcome is the level of agreement between conventional methods and sensor information for temperature.
Time Frame
2 hours
Title
Level of agreement between cardiorespiratory monitor and sensor information for oxygen saturation
Description
The primary outcome is the level of agreement between conventional methods and sensor information for oxygen saturation.
Time Frame
2 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naveen Poonai, MD
Phone
5196858500
Ext
52011
Email
poonai@hotmail.com
Facility Information:
Facility Name
Children's Hospital London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A2V5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naveen Poonai, MD
Phone
5196858500
Ext
52011
Email
poonai@hotmail.com

12. IPD Sharing Statement

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

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