To Check the Correctness of CSI 9100 Series Patient Monitor (Automated Non-Invasive Blood Pressure Sphygmomanometer) in Adults, Children, Neonates and Infants.

Phase 3

Completed

• Registration Number: CTRI/2012/04/002580
• Lead Sponsor: Opto Circuits India Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 188

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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber 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 Outcome Measures

Name	Time	Method
ATimepoint: NA