FeverNCT01845506
The Application of a Wireless Sensor Technology for Vital Statistics in CHILDREN AND ADULTS
A study testing Cardiorespiratory monitor and Wireless pressure sensor in people with Fever and COPD, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Cardiorespiratory monitor and Wireless pressure sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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%
Who cannot join
- -Subjects with unstable vital signs will be excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's Hospital London Health Sciences Center
London, Ontario, N6A2V5
Naveen Poonai, MD, 5196858500 ext. 52011, poonai@hotmail.com
About this study
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.
- Conditions
- Fever, COPD, Obesity, Congenital Heart Disease, Respiratory Distress
- Being tested
- Cardiorespiratory monitor, Wireless pressure sensor
- Keywords
- wireless pressure sensor, Elderly
- Medical subject headings
- Fever, Pulmonary Disease, Chronic Obstructive, Obesity, Heart Defects, Congenital, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiorespiratory monitorDevice
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.
Wireless pressure sensorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Wireless pressure transducer | Experimental | 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. Receives: Device: Wireless pressure sensor |
| Cardiorespiratory Monitor | Active comparator | 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. Receives: Device: Cardiorespiratory monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startDec 2021 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Lauren Faught, Michael Greff, Michael Rieder, Safieddin Safavi-Naeini
- Responsible party
- Principal investigator, Naveen Poonai, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845506
- Sponsor's protocol ID
- 2166
- Status last verified
- Sep 2020
- First submitted
- 25 Apr 2013
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of a Wireless Sensor Technology for Vital Statistics in CHILDREN AND ADULTS
- ClinicalTrials.gov ID
- NCT01845506
- Acronym / sponsor ID
- 2166
- Conditions
- Fever, COPD, Obesity, Congenital Heart Disease, Respiratory Distress
- Keywords
- wireless pressure sensor, Elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Lauren Faught, Michael Greff, Michael Rieder, Safieddin Safavi-Naeini
- Study start
- Dec 2021 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wireless pressure transducer | Experimental | Device: Wireless pressure sensorFollowing 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 comparator | Device: Cardiorespiratory monitorFollowing 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (1 listed)
- -Subjects with unstable vital signs will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiorespiratory monitorSubjects 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. | Device | Cardiorespiratory Monitor |
| Wireless pressure sensorFollowing 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 transducer |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiorespiratory monitor and Wireless pressure sensor in people with Fever and COPD, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naveen Poonai, MD (5196858500 ext. 52011, poonai@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the level of agreement between cardiorespiratory monitor and sensor information for heart rate. (time frame: 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.