Blood PressureNCT01097603
Larsen & Toubro (L&T) Noninvasive Blood Pressure Module Performance Validation
An observational study of Blood Pressure, run by Larsen & Toubro Limited.
Trial summary
To validate accuracy of the readings of noninvasive blood pressure (NIBP) module with sphygmomanometer as per the requirements of AAMI SP10:2002. This study is for adult and pediatric population. Read more about this study
- Who is it for?
- Ages 1 year to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 1 year to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Total 92 numbers of subjects or patients were studied during this study.
Who may be able to join
- Healthy subjects
- Age between 1 - 60 yrs
- Both genders
- Consenting for the study
- Patients of hypertensive, ICU and in patients of different diseases
- Age between 1 - 80 yrs
- Both genders
- Consenting for the study
Who cannot join
- Subjects suffering from cardiorespiratory, neurological or endocrinal disorders
- Subjects with alcohol abuse/dependance
- Female subjects who are pregnant or lactating
- Subjects with pace maker implantations
- Subjects: Diseased subjects
- Healthy volunteers
About this study
Official title: L&T Noninvasive Blood Pressure Module Performance Validation
To validate accuracy of the readings of noninvasive blood pressure (NIBP) module with sphygmomanometer as per the requirements of AAMI SP10:2002. This study is for adult and pediatric population.
- Conditions
- Blood Pressure
- Keywords
- Non-Invasive Blood Pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Time perspective
- Cross-sectional
Sponsor and investigators
- Lead sponsor
- Larsen & Toubro Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097603
- Sponsor's protocol ID
- LTMED01-0310
- Status last verified
- Mar 2010
- First submitted
- 31 Mar 2010
- Last updated
- 1 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L&T Noninvasive Blood Pressure Module Performance Validation
- ClinicalTrials.gov ID
- NCT01097603
- Acronym / sponsor ID
- LTMED01-0310
- Conditions
- Blood Pressure
- Keywords
- Non-Invasive Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Larsen & Toubro LimitedIndustry (pharma, biotech, devices)
- First posted
- 1 Apr 2010 (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.
To validate accuracy of the readings of noninvasive blood pressure (NIBP) module with sphygmomanometer as per the requirements of AAMI SP10:2002. This study is for adult and pediatric population.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Total 92 numbers of subjects or patients were studied during this study.
Key inclusion criteria (8 listed)
- Healthy subjects
- Age between 1 - 60 yrs
- Both genders
- Consenting for the study
- Patients of hypertensive, ICU and in patients of different diseases
Key exclusion criteria (6 listed)
- Subjects suffering from cardiorespiratory, neurological or endocrinal disorders
- Subjects with alcohol abuse/dependance
- Female subjects who are pregnant or lactating
- Subjects with pace maker implantations
- Subjects: Diseased subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Larsen & Toubro Limited.
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 1 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 1 Apr 2010.