Non-invasive Blood PressureNCT02642198
Non-Invasive Blood Pressure Monitor Accuracy in Neonatal Subjects
An observational study of Non-invasive Blood Pressure, run by Mortara Instrument at 2 sites in Italy.
Trial summary
This study is being conducted to validate the accuracy of non-invasive blood pressure (NIBP) measurement technology from Mortara Instrument, Inc. (Milwaukee, Wisconsin, USA) and Zoe Medical, Inc. (Topsfield, Massachusetts, USA) in a neonatal, infants and children up to 3 years old patient population. Read more about this study
- Who is it for?
- Ages 29 days to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-invasive Blood Pressure
- What is being tested?
- Surveyor S12 and S19 patient monitor
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 2 sitesItaly
- Study dates
- Oct 2015to Mar 2016
- 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 29 days to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study will include a minimum of 25 patients for the Method 1 and 20 patient for the Method 2, male and female, with the following weight and age (as defined by date of birth to current date; not gestational age) ranges: * At least 3 patients < 1,000 g in weight. * At least 3 patients 1,000 g to 2,000 g in weight. * At least 3 patients > 2,000 g in weight. * At least 3 patients ≥ to 29 days and < 1 year of age. * At least 3 patients ≥ 1 year and < 3 years of age.
Who may be able to join
None listed.
Who cannot join
- Patients with unstable clinical or cardiovascular conditions;
- Patients with circulatory problems which can results in different blood pressure values in the limbs;
- patients with heart disease which can results in blood pressure wave morphology abnormalities;
- patients where the difference of systolic blood pressure between two limbs is greater than 15 mm Hg or the difference of lateral diastolic blood pressure is greater than 10mmHg;
- Patients with arrhythmias.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Ospedale Pediatrico Bambino Gesù (OPBG)
Rome, Italy, 00165
Fiammetta Piersigilli, Doctor, 06 - 6859 ext. 2427, fiammetta.piersigilli@opbg.net
Zaccaria Ricci, Doctor, 06 - 6859 ext. 2258, accaria.ricci@gmail.com
- Recruiting
U.O. Neonatal Intensive Care Immature Pediatric Hospital Bambino Gesù - IRCCS
Rome, 00165
Fiammetta Piersigilli, Doctor, 06 - 6859 ext. 2427, fiammetta.piersigilli@opbg.net
Zaccaria Ricci, Doctor, 06 - 6859 ext. 2258, zaccaria.ricci@gmail.com
About this study
Official title: Clinical Investigation for Non-invasive Blood Pressure Monitor Accuracy Validation Performed on Neonatal, Infants and Children up to 3 Years Old
This study is being conducted to validate the accuracy of non-invasive blood pressure (NIBP) measurement technology from Mortara Instrument, Inc. (Milwaukee, Wisconsin, USA) and Zoe Medical, Inc. (Topsfield, Massachusetts, USA) in a neonatal, infants and children up to 3 years old patient population. The study is defined according to the International Standard "ANSI/AAMI/ISO 81060-2:2013, Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type".
Read the detailed description
The device under test is Mortara Instrument's Surveyor S12/S19 patient monitors ("Surveyor") incorporating neonatal NIBP technology. Specifically, NIBP measurements will be taken using a cuff on the patient's limb (exact location will be determined by clinician) using a variety of cuffs sized for neonates and pediatrics. The device utilizes oscillometric technology to obtain quickly and conveniently non-invasive blood pressure measurements. Results will be compared to invasive blood pressure measurements from patients already monitored with such sensors. The Device under Test will be calibrated and verified by a Mortara representative on site.
- Conditions
- Non-invasive Blood Pressure
- Being tested
- Surveyor S12 and S19 patient monitor
- Keywords
- NiBP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surveyor S12 and S19 patient monitorDevice
Also called S12/S19
Non-invasive blood pressure measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
To study is the non-invasive blood pressure measurements accuracy validation performed with the Surveyor S12 / S19 monitor in pediatric, infants and children up to 3 years patients per ISO 81060-2: 2013 requirements.
To study the accuracy of non-invasive blood pressure measurements in neonatal patients
Measured: 4 hours per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-invasive Blood PressureStudies 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
- Case only
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mortara Instrument
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642198
- Sponsor's protocol ID
- 900_OPBG_2015
- Status last verified
- Mar 2016
- First submitted
- 22 Dec 2015
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation for Non-invasive Blood Pressure Monitor Accuracy Validation Performed on Neonatal, Infants and Children up to 3 Years Old
- ClinicalTrials.gov ID
- NCT02642198
- Acronym / sponsor ID
- 900_OPBG_2015
- Conditions
- Non-invasive Blood Pressure
- Keywords
- NiBP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Mortara InstrumentIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- First posted
- 30 Dec 2015 (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.
This study is being conducted to validate the accuracy of non-invasive blood pressure (NIBP) measurement technology from Mortara Instrument, Inc. (Milwaukee, Wisconsin, USA) and Zoe Medical, Inc. (Topsfield, Massachusetts, USA) in a neonatal, infants and children up to 3 years old patient population. The study is defined according to the International Standard "ANSI/AAMI/ISO 81060-2:2013, Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type".
Detailed description
The device under test is Mortara Instrument's Surveyor S12/S19 patient monitors ("Surveyor") incorporating neonatal NIBP technology. Specifically, NIBP measurements will be taken using a cuff on the patient's limb (exact location will be determined by clinician) using a variety of cuffs sized for neonates and pediatrics. The device utilizes oscillometric technology to obtain quickly and conveniently non-invasive blood pressure measurements. Results will be compared to invasive blood pressure measurements from patients already monitored with such sensors. The Device under Test will be calibrated and verified by a Mortara representative on site.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 29 days to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study will include a minimum of 25 patients for the Method 1 and 20 patient for the Method 2, male and female, with the following weight and age (as defined by date of birth to current date; not gestational age) ranges: * At least 3 patients < 1,000 g in weight. * At least 3 patients 1,000 g to 2,000 g in weight. * At least 3 patients > 2,000 g in weight. * At least 3 patients ≥ to 29 days and < 1 year of age. * At least 3 patients ≥ 1 year and < 3 years of age.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Patients with unstable clinical or cardiovascular conditions;
- Patients with circulatory problems which can results in different blood pressure values in the limbs;
- patients with heart disease which can results in blood pressure wave morphology abnormalities;
- patients where the difference of systolic blood pressure between two limbs is greater than 15 mm Hg or the difference of lateral diastolic blood pressure is greater than 10mmHg;
- Patients with arrhythmias.
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 |
|---|---|---|
| Surveyor S12 and S19 patient monitorAlso: S12/S19Non-invasive blood pressure measurement | Device | – |
Primary outcome
To study is the non-invasive blood pressure measurements accuracy validation performed with the Surveyor S12 / S19 monitor in pediatric, infants and children up to 3 years patients per ISO 81060-2: 2013 requirements.
Time frame: 4 hours per patient
To study the accuracy of non-invasive blood pressure measurements in neonatal patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-invasive Blood Pressure, run by Mortara Instrument at 2 sites in Italy.
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 0 inclusion and 5 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 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 Fiammetta Piersigilli, MD (06 - 6859 ext. 2427, fiammetta.piersigilli@opbg.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study is the non-invasive blood pressure measurements accuracy validation performed with the Surveyor S12 / S19 monitor in pediatric, infants and children up to 3 years patients per ISO 81060-2: 2013 requirements. (time frame: 4 hours per patient). 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 23 Mar 2016.