None listed
Conditions
Interventions
Intervention1: NIBP Device: The device takes blood pressure measurements automatically using the oscillometric method. Oscillometry involves detecting the oscillations in cuff pressure caused by the o
Sponsors
Opto Circuits India Ltd
Opto Circuits India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria for adults/children: 1.Adult and children coming for any routine Out-Patient Division clinic/procedure. 2.Willingness to participate after signing informed consent. 3.Age >= 12 years (in case of adolescents/adults) or between 3 to 12 years (in case of children). Inclusion Criteria for neonates/infants: 1.Willingness to participate after informed assent by the patientâ??s legal guardian. 2.Aged between 29 days and 3 years. Presence of intra-arterial BP line.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for adults/children: 1.Female patients who are pregnant or lactating. 2.Patients with pace-maker implantation. 3.Patients suffering from cardio-respiratory, neurological or endocrinal disorders which in judgement of the Investigator deemed unfit for the study inclusion as evident from the medical history/concurrent illness(s). 4.Patients with alcohol abuse/dependence. 5.Patients based on abnormal rhythms as evident by the current ECG and medical history/concurrent illness(s). Patients with atrial fibrillation, premature ventricular beats, peripheral arterial disease, (rhythms as evident by the current ECG and medical history) and have been medically advised not to have stress testing exercises. 6.Medical or surgical indication that might prevent use of BP cuffs. Exclusion Criteria for neonates/infants: 1.Patients with pace-maker implantation. 2.Patients suffering from illnesses with an intra-arterial BP line which in judgement of the Investigator deemed unfit for the study inclusion or assessment as evident from the medical history/concurrent illness(s). 3.Patients based on abnormal rhythms as evident by the current ECG and medical history/concurrent illness(s). Patients with atrial fibrillation, premature ventricular beats, peripheral arterial disease, (rhythms as evident by the current ECG and medical history). 4.Maternal drug or alcohol dependence. 5.Medical or surgical indication that might prevent use of BP cuffs. 6.Patients on mechanical ventilation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adults and children (as two separate groups) & neonates/infants who complete the study satisfying statistical analysis. The study will be a pass if the mean error is â?¤ 5.0 mmHg with standard deviation (SD) â?¤ 8.0 mmHg. When considering the pairs in their patient set the mean error has the same limit while the maximum permissible SD is a function of the mean error at the time of data analysisTimepoint: At the time of data analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactMr Siddhartha
Opto Circuits India Ltd
Outcome results
None listed