- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01845506
The Application of a Wireless Sensor Technology for Vital Statistics in CHILDREN AND ADULTS
September 1, 2020 updated by: Naveen Poonai, Lawson Health Research Institute
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Naveen Poonai, MD
- Phone Number: 52011 5196858500
- Email: poonai@hotmail.com
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A2V5
- Children's Hospital London Health Sciences Center
-
Contact:
- Naveen Poonai, MD
- Phone Number: 52011 5196858500
- Email: poonai@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary outcome is the level of agreement between cardiorespiratory monitor and sensor information for heart rate.
Time Frame: 2 hours
|
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
Time Frame: 2 hours
|
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
Time Frame: 2 hours
|
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
Time Frame: 2 hours
|
The primary outcome is the level of agreement between conventional methods and sensor information for oxygen saturation.
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2021
Primary Completion (Anticipated)
September 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
April 25, 2013
First Submitted That Met QC Criteria
May 1, 2013
First Posted (Estimate)
May 3, 2013
Study Record Updates
Last Update Posted (Actual)
September 3, 2020
Last Update Submitted That Met QC Criteria
September 1, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2166
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Wireless pressure sensor
-
Ligue Pulmonaire NeuchâteloiseHopital Neuchatelois; Domo-Safety S.A.; Vivactis (Suisse) S.A.UnknownChronic Obstructive Pulmonary Disease | Respiratory Disease
-
University of Sao Paulo General HospitalBiologix Sistemas LtdaCompleted
-
Washington University School of MedicineCompletedSeptic Shock | Severe Sepsis | Respiratory Arrest | Cardiopulmonary Arrest | Escalation of CareUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoUnknownPrematurityUnited States
-
Brain Electrophysiology Laboratory CompanyNational Institute on Aging (NIA); Wake Forest UniversityRecruitingSleep | Mild Cognitive Impairment | Machine Learning | Memory | Transcranial Electrical StimulationUnited States
-
St. Jude Children's Research HospitalCompleted
-
Brain Electrophysiology Laboratory CompanyCompletedSleep | Sleep HygieneUnited States
-
University Medical Centre LjubljanaHyb, d.o.o., SloveniaCompletedShock | Atrial Fibrillation | Multiple Trauma | Perioperative/Postoperative Complications
-
Northwestern UniversityWearifi, Inc.CompletedVenous Leg Ulcer | Healthy AdultsUnited States