Body TemperatureNCT03206528
Clinical Evaluation of the Vital Signs Monitoring System (VSMS)
An observational study of Body Temperature and Oxygen Saturation, run by G Medical Innovations Ltd. at 1 site in Israel.
Trial summary
This is an observational, cohort-based, single-site, prospective study conducted in accordance with ISO 14155-1:2003 and ISO 14155-1:2011. The primary objectives are to evaluate the accuracy of the device's measurements/readings in comparison to a gold standard or standard of care patient monitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Body Temperature, Oxygen Saturation, Respiration
- What is being tested?
- Vital Signs Monitoring System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Apr 2017to 31 Jul 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Hospitalized patients of both genders, above 18 years of age, with ASA physical status classified as 1-4. In order to obtain the necessary results, the following shall also define the patient population: Temperature: 30-50% of subjects shall be febrile, i.e., having: * An elevated core or rectal temperature of 38.0°C or higher as measured by a clinical thermometer. * An elevated sublingual temperature of 37.5°C or higher as measured by a clinical thermometer. * An elevated Axillary temperature of 37.2°C or higher as measured by a clinical thermometer. SPO2: 10-20% of patients shall have a blood oxygen saturation level of 70-90%. ECG / Respiration: At least 20% of patients shall have some type of arrhythmia.
Who may be able to join
- Signed written informed consent
- Age above 18 years from both genders
- American Society of Anesthesiologists (ASA) physical status classification of 1-4
- Hospitalized in internal ward
Who cannot join
- Abuse of alcohol or illicit drugs
- History of mental retardation or any mental disease
- Skin irritation / Atopic dermatitis or any other skin condition in the area of patient's upper chest that might affect his/her ability to adhere the device appropriately
Trial locations and contacts
1 site in 1 country.
Peter Spiegel contact
Israel1 site, 1 recruiting
- Recruiting
Internal Ward B, Aliza Begin Building, Assaf Harofe Hospital (2nd Floor)
P.O. Beer Ya'akov, Zerifin, 70300
Anat Alon, 972 8-977-9999, alona@asaf.health.gov.il
Peter Spiegel
About this study
This is an observational, cohort-based, single-site, prospective study conducted in accordance with ISO 14155-1:2003 and ISO 14155-1:2011. The primary objectives are to evaluate the accuracy of the device's measurements/readings in comparison to a gold standard or standard of care patient monitor.
Read the detailed description
This is an observational, cohort-based, single-site, prospective clinical study enrolling up to 100 patients who are hospitalized in the internal ward. There is no control group.
The primary objectives of the study are:
- Evaluate the body temperature measured by the ear unit and validate its accuracy.
- Evaluate the accuracy of SPO2 signals and results by comparing the readings to a gold standard device with a finger sensor.
- Evaluate the ECG and respiration signals recorded by the patch device by comparing them to the signals recorded by a patient monitor with standard leads. The secondary objectives of the study are:
- Usability - evaluate the ease of use of the device by medical staff and patients (e.g., positioning, activation, replacement of patch, understanding processes and requirements).
- Evaluate the signals quality and the patch adherence after 5 - 7 days on the chest.
The study will assess the safety and effectiveness of the Vital Signs Monitoring System (VSMS) for its intended use/proposed indications. Data will be collected while the VSMS is adhered to each patient for the entire hospitalization period, up to 7 days. There is no follow-up required.
- Conditions
- Body Temperature, Oxygen Saturation, Respiration, ECG
- Being tested
- Vital Signs Monitoring System
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital Signs Monitoring SystemDevice
The VSMS will be adhered to each enrolled patient for the entire hospitalization period.
| Study group | Role | What they receive |
|---|---|---|
| VSMS with ear unit | application of Vital Signs Monitoring System with ear unit for 6-10 days during hospitalization (throughout their admission period) Receives: Device: Vital Signs Monitoring System | |
| VSMS without ear unit | application of Vital Signs Monitoring System without ear unit for 6-10 days during hospitalization (throughout their admission period) Receives: Device: Vital Signs Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Temperature measured in units of Celsius/Fahrenheit
Validation of measurement accuracy of skin temperature as compared to gold standard.
Measured: 6-10 days
Oxygen Saturation measured in units of percentage peripheral saturated oxygen
Validation of measurement accuracy of peripheral oxygen saturation as compared to gold standard.
Measured: 6-10 days
.ECG signal recording and Respiration measured in units heart beat per minute
Assess quality of device's recorded ECG and respiration signals as compared to patient monitor with standard leads
Measured: 6-10 days
Secondary outcomes (1)
Quality of recorded signal
Evaluate the quality of recorded signals in time by comparing signal of day 1 with signal in last day of adherence of the patch
Measured: after 5-7 days of device usage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start25 Apr 2017
- Primary completion31 Jul 2017 (estimated)
- Study completion31 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body TemperatureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G Medical Innovations Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moshe Tishler, Professor, Principal investigator, Assaf Harofeh Hospital/Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206528
- Sponsor's protocol ID
- CLN-7.4.7.10.20
- Status last verified
- Jun 2017
- First submitted
- 15 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Vital Signs Monitoring System (VSMS)
- ClinicalTrials.gov ID
- NCT03206528
- Acronym / sponsor ID
- CLN-7.4.7.10.20
- Conditions
- Body Temperature, Oxygen Saturation, Respiration, ECG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- G Medical Innovations Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 31 Jul 2017 (estimated)
- Study completion
- 31 Jul 2017 (estimated)
- First posted
- 2 Jul 2017 (actual)
- 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.
This is an observational, cohort-based, single-site, prospective study conducted in accordance with ISO 14155-1:2003 and ISO 14155-1:2011. The primary objectives are to evaluate the accuracy of the device's measurements/readings in comparison to a gold standard or standard of care patient monitor.
Detailed description
This is an observational, cohort-based, single-site, prospective clinical study enrolling up to 100 patients who are hospitalized in the internal ward. There is no control group.
The primary objectives of the study are:
- Evaluate the body temperature measured by the ear unit and validate its accuracy.
- Evaluate the accuracy of SPO2 signals and results by comparing the readings to a gold standard device with a finger sensor.
- Evaluate the ECG and respiration signals recorded by the patch device by comparing them to the signals recorded by a patient monitor with standard leads. The secondary objectives of the study are:
- Usability - evaluate the ease of use of the device by medical staff and patients (e.g., positioning, activation, replacement of patch, understanding processes and requirements).
- Evaluate the signals quality and the patch adherence after 5 - 7 days on the chest.
The study will assess the safety and effectiveness of the Vital Signs Monitoring System (VSMS) for its intended use/proposed indications. Data will be collected while the VSMS is adhered to each patient for the entire hospitalization period, up to 7 days. There is no follow-up required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VSMS with ear unit | – | Device: Vital Signs Monitoring Systemapplication of Vital Signs Monitoring System with ear unit for 6-10 days during hospitalization (throughout their admission period) |
| VSMS without ear unit | – | Device: Vital Signs Monitoring Systemapplication of Vital Signs Monitoring System without ear unit for 6-10 days during hospitalization (throughout their admission period) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients of both genders, above 18 years of age, with ASA physical status classified as 1-4. In order to obtain the necessary results, the following shall also define the patient population: Temperature: 30-50% of subjects shall be febrile, i.e., having: * An elevated core or rectal temperature of 38.0°C or higher as measured by a clinical thermometer. * An elevated sublingual temperature of 37.5°C or higher as measured by a clinical thermometer. * An elevated Axillary temperature of 37.2°C or higher as measured by a clinical thermometer. SPO2: 10-20% of patients shall have a blood oxygen saturation level of 70-90%. ECG / Respiration: At least 20% of patients shall have some type of arrhythmia.
Key inclusion criteria (4 listed)
- Signed written informed consent
- Age above 18 years from both genders
- American Society of Anesthesiologists (ASA) physical status classification of 1-4
- Hospitalized in internal ward
Key exclusion criteria (3 listed)
- Abuse of alcohol or illicit drugs
- History of mental retardation or any mental disease
- Skin irritation / Atopic dermatitis or any other skin condition in the area of patient's upper chest that might affect his/her ability to adhere the device appropriately
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 |
|---|---|---|
| Vital Signs Monitoring SystemThe VSMS will be adhered to each enrolled patient for the entire hospitalization period. | Device | VSMS with ear unit, VSMS without ear unit |
Primary outcome
Skin Temperature measured in units of Celsius/Fahrenheit
Time frame: 6-10 days
Validation of measurement accuracy of skin temperature as compared to gold standard.
Oxygen Saturation measured in units of percentage peripheral saturated oxygen
Time frame: 6-10 days
Validation of measurement accuracy of peripheral oxygen saturation as compared to gold standard.
.ECG signal recording and Respiration measured in units heart beat per minute
Time frame: 6-10 days
Assess quality of device's recorded ECG and respiration signals as compared to patient monitor with standard leads
1 secondary outcome
Quality of recorded signal
Time frame: after 5-7 days of device usage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Peter Spiegel contact
Moshe Tishler, Professor principal investigator
Assaf Harofeh Hospital/Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Temperature and Oxygen Saturation, run by G Medical Innovations Ltd. at 1 site in Israel.
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 4 inclusion and 3 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 2 Jul 2017. 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 Israel. 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 Anat Alon (972 8-977-9999, alona@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Temperature measured in units of Celsius/Fahrenheit (time frame: 6-10 days). The study lists 3 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 2 Jul 2017.