HemoSphere Alta Study
ConditionHemodynamic Instability
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBecton, Dickinson and Company
About this trial
A prospective, non-randomized single arm study using the HemoSphere Alta Advanced Monitoring Platform and associated devices in adult subjects. Data collected from enrolled study subjects will be used for continual device development purposes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent
Age ≥ 18 years
Planned monitoring with a pulmonary artery catheter
Patient scheduled to undergo cardiac or liver transplant surgery lasting > 2 hours
Disqualifiers
Inability to provide informed consent
Pregnancy as confirmed per EMR
Patients deemed not suitable for the study at the discretion of the Investigator
Participation in another study that clinically interferes with the current study
Trial population
Up to 100 subjects with planned monitoring with a pulmonary artery catheter in the Operating Room (OR). Subjects must meet the eligibility criteria for the Primary Cohort to be enrolled in the study. Subjects may further qualify for inclusion in Sub-Cohorts A and/or B. Sub-Cohort A Right Ventricular Failure (RVF) will include up to 25 subjects undergoing either non-cardiac or cardiac surgery with a planned transesophageal echocardiogram (TEE) assessment. Sub-Cohort B Cerebral Autoregulation Index (CAI) will include up to 50 subjects aged ≥ 45 years undergoing Cardiopulmonary Bypass (CPB) with the ability to place ForeSight and Acumen IQ sensors and are at high risk for cerebrovascular disease.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
HemoSphere Alta Monitor, Swan-Ganz IQ pulmonary arterial catheter, ForeSight IQ Large sensor, and Acumen IQ sensor
DeviceSubjects with planned monitoring with a pulmonary artery catheter in the operating room, will be monitored with the above listed devices.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Primary Cohort (Swan)1 intervention
Trial outcomes
Primary outcomes
1
Data Collection using HemoSphere Alta Advanced Monitoring Platform and associated devices
Number of patients who receive monitoring using the HemoSphere Alta Advanced Monitoring Platform and associated devices for continued device development.
Time frame
Up to 72 hours of device data collection during surgery and ICUSponsors and contacts
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Source ClinicalTrials.gov