None listed
Conditions
Brief summary
The assessment of blood pressure (BP) is the cornerstone of antenatal, intrapartum, and postnatal care. Accurate measurement of BP enables the diagnosis and management of hypertensive disorders of pregnancy, including chronic hypertension, gestational hypertension, and preeclampsia. In recent years, a range of cuffless, non-invasive technologies have emerged for blood pressure measurement. A key advantage of these devices is that they can capture blood pressure frequently – either at short, repeated intervals or continuously—without the discomfort and practical limitations of cuff inflation. By avoiding arterial occlusion, they may offer a more convenient and acceptable approach to blood pressure monitoring in both hospital and ambulatory settings. Further, these devices may offer advantages in the setting white coat hypertension. Many of these systems rely on photoplethysmography (PPG) signals, and several have already obtained commercial regulatory clearance in the United States and/or Europe and Australia. PPG-based monitoring is a means of beat-to-beat BP monitoring. In PPG-based monitoring, a light source is applied to the skin, and a photodetector measures the reflected light from the tissue. The detected light can be used to measure blood volume changes and thus BP. The aim of this study is to prospectively evaluate the accuracy of BP measurements obtained from a novel, commercially available cuffless, non-invasive PPG-based chest patch monitor (Biobeat, Biobeat Medical Smart Monitoring) during pregnancy. BioBeat is a 3cm x 3cm diameter sensor which can be applied to the upper torso and relies on PPG-based monitoring to provide beat-to-beat BP readings. The device requires 1-3 blood pressure entries from a cuff-based calibration for initialisation. The patch can be applied by the research team, and patients can continue to go about their day as normal. Should the clinical efficacy of this monitor be proven in pregnant women, there is room for it to be adopted for use in antenatal and postnatal care and optimise monitoring of women with HDP.
Interventions
The intervention in this study is a cuffless wearable Blood Pressure (BP) monitoring patch which uses Photoplethysmography(PPG)-based monitoring to measure blood pressure. After consent, the Biobeat patch will be applied to the chest by an independent researcher involved in the research team, and initialized according to manufacturer’s instructions. Participants will then undergo continuous BP monitoring for 3 days, after which the patch will be removed. If a participant undergoes an emergency c
The intervention in this study is a cuffless wearable Blood Pressure (BP) monitoring patch which uses Photoplethysmography(PPG)-based monitoring to measure blood pressure. After consent, the Biobeat patch will be applied to the chest by an independent researcher involved in the research team, and initialized according to manufacturer’s instructions. Participants will then undergo continuous BP monitoring for 3 days, after which the patch will be removed. If a participant undergoes an emergency caesarean section during the study period, the patch will be removed prior to delivery. The device being validated is the Biobeat Chest Patch, developed by Biobeat Technologies, which measures peripheral blood pressure. Biobeat Technologies will be donating the devices for use in this validation study. The device a 3cm x 3cm sensor which is applied using a 5cm x 5cm adhesive patch. Application of the patch is not expected to inconvenience participants in any way and participants can go about their day as normal. It does not make any noise and has an internal battery. • Approved Name: 613WP • Trade Name: Biobeat • Manufacturer of Device: Bio-Beat Technologies • Supplier of Device: Bio-Beat Technologies • Approved Therapeutic Indications: Hypertension Management and Monitoring • Known Adverse Events: Skin Irritation • Known Contra-Indications or Warnings: None • Size: 3 cm x 3 cm diameter sensor applied using a 5cm x 5cm adhesive patch This device will only be applied to pregnant women >24 weeks who are inpatients under the Monash Obstetrics team at Monash Medical Centre. Adherence will be monitored using data completeness.
Sponsors
Professor Kirsten Palmer , Monash Centre for Health Research and Implementation
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Females >18 years old who are >24 weeks gestation and are inpatients under Monash Maternity at Monash Medical Centre Clayton Expected to be hospitalised and clinically stable for at least 72 hours
Exclusion criteria
• Unable to give informed consent • Significant pre-existing arrhythmia • Pre-existing dermatological or allergic conditions • Clinically unstable: o Signs of imminent delivery o Presence of life-threatening bleeding o Abnormal cardiotocography o Needing emergency intervention o Severe hypertension (Systolic BP greater than or equal to 160mmHg and/or Diastolic BP greater than or equal to 110mmHg) o Hypertensive crisis requiring immediate intravenous antihypertensive treatment
Outcome results
None listed