Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNorthwestern University
About this trial
The diagnosis of hypertensive disease during pregnancy is predicated on strict blood pressure thresholds: 140/90 on at least two occasions measured four hours apart for both gestational hypertension and preeclampsia. An improvement in diagnostic accuracy of even 5mm Hg would be significant, as reflected by the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO)consensus for validation of non-invasive blood pressure (NIBP) devices during pregnancy. Given the known inaccuracies of upper arm cylindrical cuff measurements in morbidly obese patients, a conical cuff which provides more accurate measurements will translate into direct patient benefit via more informed diagnosis and management. Fewer women may be exposed to unnecessary treatment, preterm delivery, and/or cesarean section. Recognizing the increasing prevalence of morbid obesity and hypertensive disease amongst pregnant women in the United States, the identification of a more accurate non-invasive cuff is desperately needed. Increasing the accuracy of NIBP measurements on Labor and Delivery has the potential to directly impact the management of tens of thousands of morbidly obese pregnant women diagnosed with hypertensive disease in the United States every year. Establishing the level of agreement between conical forearm and cylindrical upper arm cuffs will shed light on the presence and magnitude of any disparity between measurement methods.
STUDY ENDPOINTS:
Primary Outcome Measures:
* Agreement between conical and cylindrical cuff systolic blood pressure across groups * Agreement between conical and cylindrical cuff diastolic blood pressure across groups
Secondary Outcome Measures:
• Agreement between conical and cylindrical cuff mean arterial pressure
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women who are 18 years of age or older with a
Body mass index (BMI) of 20 kg/m2 or greater
Present to Labor and Delivery with or without a diagnosis of gestational hypertension, preeclampsia, or chronic hypertension with super-imposed preeclampsia, in spontaneous labor or for induction of labor
Disqualifiers
Significant peripheral arterial disease resulting in at least a 10 mm Hg blood pressure difference between both arms
History of repaired or unrepaired congenital heart disease
History of significant arrythmia
History of pacemaker or implantable cardioverter defibrillator placement
Trial design
Design model
Parallel
Treatments tested in this trial
Upper Arm Cylindrical Blood Pressure Cuff
DeviceIn Group 1, the upper arm cylindrical cuff is inflated first, followed by inflation of the forearm conical cuff.
Forearm Conical Blood Pressure Cuff
DeviceIn Group 2, the forearm conical cuff is inflated first, followed by inflation of the upper arm cylindrical cuff.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Group 1 Upper arm cylindrical cuffActive comparator 1 intervention
Group B: Group 2 Forearm conical cuffExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Agreement between conical and cylindrical cuff systolic blood pressure as measured by mean absolute deviance
Agreement between conical and cylindrical cuff systolic blood pressure across 4 distinct subject groups:(1) normotensive/non-obese (2) normotensive/obese (3) hypertensive/non-obese and (4) hypertensive/obese.
Time frame
Through study completion, an average of 1 year2
Agreement between conical and cylindrical cuff diastolic blood pressure as measured by mean absolute deviance
Agreement between conical and cylindrical cuff diastolic blood pressure across 4 distinct groups: (1) normotensive/non-obese (2) normotensive/obese (3) hypertensive/non-obese and (4) hypertensive/obese.
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Agreement between conical and cylindrical cuff mean arterial pressure as measured by mean absolute deviance
Agreement between conical and cylindrical cuff MAP arterial pressure among the 4 distinct groups:(1) normotensive/non-obese (2) normotensive/obese (3) hypertensive/non-obese and (4) hypertensive/obese.
Time frame
Through study completion, an average of 1 year2
Likert scale patient satisfaction scores for conical and cylindrical cuff measurements
Patient satisfaction scores for conical and cylindrical cuff measurements will be measured with a 5-question survey using 5-point scale, ranging from 0 (very painful/very dissatisfied) to 5 (not painful at all/very satisfied).
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov