Larsen & Toubro (L&T) Noninvasive Blood Pressure Module Performance Validation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01097603
Recruitment Status : Completed
First Posted : April 1, 2010
Last Update Posted : April 1, 2010
Information provided by:
Larsen & Toubro Limited

Brief 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.

Condition or disease
Blood Pressure

Study Type : Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: L&T Noninvasive Blood Pressure Module Performance Validation

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Ages Eligible for Study:   1 Year to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Total 92 numbers of subjects or patients were studied during this study.

Subjects: Healthy volunteers

Inclusion Criteria:

  • Healthy subjects
  • Age between 1 - 60 yrs
  • Both genders
  • Consenting for the study

Exclusion Criteria:

  • 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

Inclusion Criteria:

  • Patients of hypertensive, ICU and in patients of different diseases
  • Age between 1 - 80 yrs
  • Both genders
  • Consenting for the study

Exclusion Criteria:

  • Healthy volunteers

Responsible Party: L&T MEDICAL EQUIPMENTS & SYSTEMS, MYSORE,INDIA, LARSEN & TOUBRO LIMITED Identifier: NCT01097603     History of Changes
Other Study ID Numbers: LTMED01-0310
First Posted: April 1, 2010    Key Record Dates
Last Update Posted: April 1, 2010
Last Verified: March 2010

Keywords provided by Larsen & Toubro Limited:
Non-Invasive Blood Pressure