Data Collection Study Using CS BP Pillow System
A Data Collection Study to Collect Blood Pressure Data Using the CardiacSense BP Pillow System for Algorithm Development
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This is a prospective data collection single-site study designed to collect blood pressure (BP) waveforms and estimate BP via the CS BP Pillow System, CS BP Plate System and IR-Pillow in parallel with arterial line (A-line data). The data collected will be used for algorithms development of the CS BP systems.
The study includes a screening phase followed by BP data collection session using the CS Pillow System, CS BP Plate System, IR-Pillows and an A-line. Participants will be recruited by the Investigator according to the study eligibility criteria.
A total of 50 participants who meet eligibility criteria will be enrolled in the study in 3 cohorts: Cohort I and Cohort II will include 20 participants, and Cohort III will include 10 participants.
After informed consent is obtained, demographic information, medical history, current medications use and wrist circumference measurement will be recorded. A modified Allen's test, a lateral difference test and additional assessments will be performed to confirm eligibility criteria. In participants who meet the eligibility criteria, the CS BP study systems will be fitted and an A-line will be inserted into the radial artery. A dynamic response calculation will be performed to confirm the integrity of the inserted line.
After the participant has rested for at least 5 minutes, simultaneous BP recordings using the CS BP Pillow System, CS BP Plate System, IR Pillows and A-line will begin and continue for about 1 hour.
Upon completion of data collection, all devices will be removed, and adverse events will be assessed and documented.
The end of study for each participant is defined as the completion of device removal and completion of adverse event follow-up. The end of the study is defined as completion of 50 evaluable participant datasets
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Colorado
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Louisville, Colorado, Estados Unidos, 80027
- Element Boulder Avista Adventist Hospital Plaza
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 20-80 years old.
- Ability and willingness to sign and understand an informed consent form.
- The participant has a palpable radial pulse in both wrists.
- The participant is willing and able to be fitted with the investigational device, A-line, and reference cuff, and is willing and able to undergo all study procedures, including 1 hour of recording with the investigational device and A-line.
- The participant was fitted with both CS BP Plate System devices (one for each hand) and CardiacSense technician has determined the measurement quality to be sufficient.
Exclusion Criteria:
- Participant who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the participant or interfere with the data collected.
- Participant whose body habitus precludes them from wearing the investigational device on their wrists.
- Female participants who self-reported as pregnant based on a urine pregnancy test, or who are self-reported as trying to get pregnant or who are breastfeeding.
- Participant whose BMI is greater than 35.
- Participant with a documented medical history of cardiac arrhythmia.
- Participant with diagnosed diabetes mellitus.
- Participant with implanted cardiac defibrillators or pacemakers, Ventricular Assist Device (VAD) or other mechanical circulatory support devices, whether intracorporal or extracorporeal.
- Participant with stage 4 or stage 5 end-stage renal disease, or participants with arteriovenous shunts.
- Participant with pheochromocytoma or primary hyperaldosteronism.
- Participant with diagnosed heart failure with New York Heart Association (NYHA) class III/IV, or participants with a history of stroke.
- Participant with a known clotting disorders or currently taking a prescription anticoagulants (daily aspirin use is permitted).
- Participant with an infection requiring antibiotics.
- Participant with peripheral artery disease
- Participants with compromised circulation, including Raynaud's syndrome.
- Participant has a fracture, severe trauma, or anatomical deformity involving the wrist intended for placement of the investigational devices, which could interfere with proper fitting or function of the devices.
- Participant with moderate to severe valvulopathies.
- Participant with primary vasculitis.
- Participant with tremors or otherwise unable to remain still for 1 hour.
- The left to right arm lateral difference of the average systolic blood pressure values is more than 15 mmHg or the lateral difference of the average diastolic blood pressure values is more than 10 mmHg.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: CS BP Pillow System, CS BP Plate System and IR Pillows
Data collected from the systems will be compared to data collected from Arterial Line
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Device: CS Pillow System CS Pillow System estimates blood pressure using ECG and tonometry signals. It includes a tonometry sensor embedded in a biocompatible pillow, positioned over the radial artery with a wristband for improved sensitivity and comfort and ECG chest wet electrodes fitted on the torso. CS BP Plate System estimates blood pressure using ECG and PPG. The system consists of a handheld, battery-operated Plate with integrated optical and ECG sensors contacted by the thumb. Infrared (IR) Pillow contain a PPG sensor (IR LED and photodiode) embedded in a biocompatible "pillow. The IR Pillow is placed over the radial artery. This sensor enables estimation of arterial compliance, an important factor influencing the blood pressure-blood volume relationship. Data collected using the CS BP Pillow System and the CS Plate System will be compared to data collected using Arterial Line.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of subjects with complete protocol-defined multi-modal physiological signal acquisition
Prazo: day 1, 1 hour
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The primary outcome measure is the number of subjects with complete protocol-defined multi-modal physiological signal acquisition. Multi-modal physiological signal acquisition includes simultaneous recording of: (i) photoplethysmography (PPG); ii) single lead electrocardiography (ECG); iii) tonometry signals from the investigational BP Pillow System ; (iv) IR PPG signals (v) continuous invasive arterial blood pressure signals. |
day 1, 1 hour
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 027_BP_DC_US
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