The Continuity Study
ConditionBlood Pressure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBecton, Dickinson and Company
About this trial
A before and after interventional cohort study comparing intermittent blood pressure measurement using the oscillometric arm cuff to continuous noninvasive blood pressure (cNIBP) measurement using the VitaWave finger cuffs in subjects undergoing elective surgery in an outpatient setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent
Age ≥ 18 years
American Society of Anesthesiologists (ASA) Physical Status ≥ 2
Scheduled for elective noncardiac surgery with intermittent arterial blood pressure monitoring using oscillometric arm cuff
Disqualifiers
Patient who is known to be pregnant
Patient with existing or planned arterial pressure catheter
Patient in whom systolic arterial pressure differs by more than 20 mmHg between the right and left arms
Inability to place oscillometric cuff on the subject's upper extremity
Trial design
Design model
Sequential
Treatments tested in this trial
HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors
DeviceDevices are applied for monitoring throughout the duration of the procedure
Treatment groups
188 Participants
are divided into 2 treatment groupsGroup A: Cohort 1 - Standard of CareExperimental treatment 1 intervention
Group B: Cohort 2 - Standard of Care with cNIBP MonitoringExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of adult patients undergoing elective noncardiac surgery in the outpatient setting who experience hypotension, defined as a mean arterial pressure (MAP) < 65 mmHg, for a total duration of at least 5 minutes.
Time frame
Through Study Completion, approximately 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov