Health Condition 1: Z758- Other problems related to medicalfacilities and other health care Health Condition 2: I489- Unspecified atrial fibrillation and atrial flutter Health Condition 3: O80- Encounter for full-term uncomplicated delivery Health Condition 4: O82- Encounter for cesarean delivery without indication Health Condition 5: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Walnut Medical Pvt Ltd.s BP device (Korotkoff sounds and oscillatory waveforms based digital BP apparatus): An automated digital BP apparatus that integrates Kor
Sponsors
Mr Siddharth Dhawan
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willingness to provide informed consent and voluntary participation in the study 2. Both normotensive or hypertensive Participants either on treatment or not on treatment for hypertension 3. Special population: pregnancy including pre-eclampsia, midarm circumference of greater than 42 cm and atrial fibrillation
Exclusion criteria
Exclusion criteria: 1.K1 or K5 of Korotkoff sounds is not audible 2. Participants with systolic BP difference more than 12 mmHg and/or diastolic BP difference more than 8 mmHg in any 2 of the 4 reference (average of two observers) BP measurements (R1 to R4) 3. BP measurement beyond the desired target reading of the measuring apparatus 4. Midarm circumference and cuff size beyond the desired target 5. Target population beyond the desired special groups
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development phase: 1. Display of BP reading by index device through the integration of Korotkoff sounds and oscillatory waveform Validation phase: 1. Frequency of tolerable error of less than or equal to 5 mmHg 2. Whether estimated tolerable error (less than or equal to 5 mmHg) is found in at least 85% cases 3. Level of accuracy i. High accuracy: The estimated error (difference between the reference and test device measurement) of less than or equal to 5 mmHg is found in at least 85% cases ii. Moderate accuracy: The estimated error (difference between the reference and test device measurement)of more than 5 mmHg but less than or equal to 10 mmHg is found in at least 85% cases iii. Low accuracy: The estimated error (difference between the reference and test device measurement)of more than 10 mmHg is found in at least 85% casesTimepoint: one time | — |
Secondary
| Measure | Time frame |
|---|---|
| Development phase: 1. Any adverse event associated with the use of the device in the participants Validation phase: 1. Validation of the index device with different cuff size and special population like participants with pregnancy, arm circumference more than 42 cm, and atrial fibrillation. 2. Any adverse event associated with the use of the device in the participantsTimepoint: one time | — |
Countries
India
Contacts
Public ContactMr Siddharth Dhawan
Clinical Studies and Trials Unit Division, ICMR
Outcome results
None listed