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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Naveen Poonai, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01845506
First received: April 25, 2013
Last updated: May 1, 2013
Last verified: April 2013
  Purpose

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 Intervention
Fever
COPD
Obesity
Congenital Heart Disease
Respiratory Distress
Device: Cardiorespiratory monitor
Device: Wireless pressure sensor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • The primary outcome is the level of agreement between cardiorespiratory monitor and sensor information for heart rate. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    The primary outcome is the level of agreement between conventional methods and sensor information for oxygen saturation.


Estimated Enrollment: 500
Study Start Date: September 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845506

Contacts
Contact: Naveen Poonai, MD 5196858500 ext 52011 poonai@hotmail.com

Locations
Canada, Ontario
Children's Hospital London Health Sciences Center Not yet recruiting
London, Ontario, Canada, N6A2V5
Contact: Naveen Poonai, MD    5196858500 ext 52011    poonai@hotmail.com   
Sponsors and Collaborators
Lawson Health Research Institute
  More Information

No publications provided

Responsible Party: Naveen Poonai, Assistant Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01845506     History of Changes
Other Study ID Numbers: 2166
Study First Received: April 25, 2013
Last Updated: May 1, 2013
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
wireless pressure sensor
Elderly

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 23, 2014