Wireless pressure sensor for Fever

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Children's Hospital London Health Sciences Center, London, Canada
Fever+6 More
Wireless pressure sensor - Device
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

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

See full description

Eligible Conditions

  • Fever
  • Congenital Heart Disease (CHD)
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Obesity
  • Respiratory Distress

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Wireless pressure sensor will improve 4 primary outcomes in patients with Fever. Measurement will happen over the course of 2 hours.

2 hours
Level of agreement between cardiorespiratory monitor and sensor information for blood pressure
Level of agreement between cardiorespiratory monitor and sensor information for oxygen saturation
Level of agreement between cardiorespiratory monitor and sensor information for temperature
The is the level of agreement between cardiorespiratory monitor and sensor information for heart rate.

Trial Safety

Trial Design

2 Treatment Groups

Cardiorespiratory Monitor
1 of 2
Wireless pressure transducer
1 of 2
Active Control
Experimental Treatment

This trial requires 500 total participants across 2 different treatment groups

This trial involves 2 different treatments. Wireless Pressure Sensor is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Wireless pressure transducer
Device
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.
Cardiorespiratory Monitor
Device
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 hours for reporting.

Who is running the study

Principal Investigator
N. P.
Prof. Naveen Poonai, Assistant Professor
Lawson Health Research Institute

Closest Location

Children's Hospital London Health Sciences Center - London, Canada

Eligibility Criteria

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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%

Patient Q&A Section

How many people get heart defects, congenital a year in the United States?

"Approximately 1 in 60 fetuses will be affected by a chromosomal abnormality. Approximately 15% of these fetuses will die in utero. The prevalence of heart defects, chromosomal abnormalities, and fetal death may have significantly evolved in industrialized societies and should be considered when discussing prenatal testing." - Anonymous Online Contributor

Unverified Answer

What are common treatments for heart defects, congenital?

"In the US and Canada, nearly 90% of surgeries for CHD are repairs. In Europe and Australia, about 70% of surgeries are repairs. The high incidence of surgeries indicates a large demand for pediatric cardiac surgeons. The high complication rate in CHD surgery can be attributed to the relatively low quality of information available to the pediatric surgeon, the lack of experience of many CHD surgeons with pediatric CHD surgeries, and the lack of a standardized approach to the management of CHD." - Anonymous Online Contributor

Unverified Answer

Can heart defects, congenital be cured?

"A number of congenital defects can be cured in the right circumstances and the future prospects are bright in the field of repair of these conditions. The key lies in the appropriate referral mechanism and a good collaboration between cardiothoracic surgeons and pediatric surgeons." - Anonymous Online Contributor

Unverified Answer

What causes heart defects, congenital?

"There are many causes of heart defects, but congenital heart disease is often due to genetic factors. Many women may develop symptoms of a heart problem before getting pregnant. People who have experienced problems in pregnancy typically seek healthcare before starting antenatal care. Having children is a major risk factor for developing heart problems, but it is hard to predict who will have problems and how it may affect the parents. Any heart problems a woman might have are usually treatable." - Anonymous Online Contributor

Unverified Answer

What is heart defects, congenital?

"Congenital heart defects cause a significant number of birth defects. The most common defects are pulmonary valve defects. The defects can be divided into two groups depending on their timing of occurrence during fetal development: cyanotic heart defects (CHD), and noncyanotic heart defects (CHD). At the time the fetus is conceived, CHD may not be apparent externally; however, the unborn fetuses do not develop the fetal lung circulation for their own good. Although the neonates, even in the absence of CHD, most commonly present with cyanosis as the only manifestation of the defect, some are born without any external presentation of the defect. Some congenital heart defects are not detectable until after birth, i.e." - Anonymous Online Contributor

Unverified Answer

What are the signs of heart defects, congenital?

"To date there are several signs of heart defects, congential. None of them are conclusive. They include chest pain and a murmur, not all of them are specific, but can be very helpful for primary diagnosis of heart disease. The systolic murmur was found in all cases. It means that systolic murmur, not all the other signs of heart defects, congential, can be used to diagnose heart disease." - Anonymous Online Contributor

Unverified Answer

How serious can heart defects, congenital be?

"The serious potential of these defects, if not corrected at the time of diagnosis, can be life-threatening to both patient and clinician. They can also severely hinder the future functioning of an affected child's mental, physical, and intellectual development. It is essential to have a high degree of knowledge regarding the diagnosis and management of these conditions. With this foundation, parents can have a better understanding in how to help their child and will be better proactive on the health of their child and more likely to provide support to family members." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving wireless pressure sensor?

"There has been no research on wireless pressure sensor in heart defect clinic. The result of this study shows that Wireless Pressure Sensor is suitable in heart defect clinic because of better detection accuracy and lower cost. Moreover, it not only helps improve detection accuracy of heart defect at the first glance, but also helps to reduce the delay in consultation of heart defects." - Anonymous Online Contributor

Unverified Answer

What does wireless pressure sensor usually treat?

"We have found out the usual application of pressure sensor, which includes the measurement of pressure, as well as other sensors, such as the oxygen level, temperature, temperature deviation, humidity, and pH, etc. There are also [therapy tips] for the treatment of these common problems. We haven't found out, though, the applications of wireless pressure sensor in [rehabilitation] fields, which are still far from being familiarized to us. We want to try our best to increase the number of studies which are conducted in the different areas. We'd like to thank the research team at the Biomedical Center of Shanghai Medical College, Shanghai, China, who worked with us, for the clinical applications of wireless pressure sensor." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of heart defects, congenital?

"A significant genetic component is suspected for the aetiology of cardiac defects in newborns, though the degree and degree if the involvement of environmental and genetic factors is not clear." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of wireless pressure sensor?

"Most users (91%) experienced at least one side effect while the rest (09%) experienced one or two adverse effects. Most common adverse effects were: (1) headache, (2) sore throat, (3) body ache or fatigue, and (4) nausea. In the rare adverse reactions the severity was generally not severe, but can become more severe and dangerous if ignored. Most common side effects were also mild in severity." - Anonymous Online Contributor

Unverified Answer

Does heart defects, congenital run in families?

"Results from a recent paper demonstrates a significant increase in the frequency of cardiac defects in pregnancies of siblings with the same cardiac defects and shows a significant genetic predisposition in the population of patients with cardiac defects and the development of heart defects in their offspring. Such family history of heart defects does not appear to occur in the general population." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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