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Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients

NCT06466161 · Northwestern University
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Official title
Evaluation of the Agreement Between Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients
About this study
After participants have provided written informed consent they will be enrolled into one of four groups: (1) normotensive/non-obese (2) normotensive/obese (3) hypertensive/non-obese and (4) hypertensive/obese. The threshold for hypertension will be a BP measurement greater than 140/90 mmHg on two occasions at least 4 hours apart. After informed consent has been obtained, body weight (kg) and height (cm) will be measured on calibrated scales and BMI calculated. Arm circumference will be measured proximally just beneath the axilla, at mid- point between the acromion and the olecranon, and distally just above the antecubital fossa in centimeters. Forearm circumference will be measured, in millimeters, proximally just beneath the olecranon, at mid-point between the olecranon and the styloid apophysis, and distally just above the styloid apophysis. Upper arm length will be measured from the acromion to the olecranon in centimeters. Forearm length will be measured from the olecranon to the styloid apophysis in centimeters. Upper arm cuffs will be placed at the mid-point between the acromion and the olecranon processes. All BP measurements will be obtained from the participants while in the sitting position, and the arm contralateral to the peripheral intravenous catheter (PIV) will be chosen for measurement. If the PIV has not yet been placed, the arm selection will be made by the patient. Baseline BP measurement will be performed at the upper arm after at least a 5-minute resting period utilizing a large-sized cylindrical cuff. Baseline BP measurement at the forearm will be performed using a conical forearm cuff previously validated in non-pregnant patients with arm circumferences greater than or equal to 40 cm23 (RADIAL-CUF, GE HealthCare, Milwaukee, Wisconsin). The forearm cuff will be placed 3 cm from the styloid process of the ulna palpable at the wrist. After two minutes have elapsed since the baseline measurements, sequential, paired BP measurements will then be obtained by cycling either the upper arm cylindrical cuff or forearm conical cuff, waiting 60 seconds after the measurement, then cycling the other cuff. The choice of cuff to be cycled first (conical or cylindrical) will be block randomized. Additional sequential measurements will then be obtained 2, 4, 6, 8, and 10 minutes after the first set. After the initial measurements, the upper arm cuff will automatically cycle every 15 minutes. Thus, all patients will have six sets of sequential BP measurements. Any decision to initiate antihypertensive therapy will be made by the patient's obstetrical provider, using an institutional algorithm and with reference to cylindrical cuff pressures.
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * History of sickle cell disease * History of Raynaud's phenomenon on any extremity * History of lymph node dissection of either upper extremity * Patients who are less than 18 years of age
Study design
Enrollment target: 110 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-29
Estimated completion: 2027-09-01
Last updated: 2026-04-13
Interventions
Device: Upper Arm Cylindrical Blood Pressure CuffDevice: Forearm Conical Blood Pressure Cuff
Primary outcomes
  • Agreement between conical and cylindrical cuff systolic blood pressure as measured by mean absolute deviance (Through study completion, an average of 1 year)
  • Agreement between conical and cylindrical cuff diastolic blood pressure as measured by mean absolute deviance (Through study completion, an average of 1 year)
Sponsor
Northwestern University · other
Contacts & investigators
ContactAdithya Bhat, MD · contact · adithya.bhat@northwestern.edu · 312-472-3585
ContactPaul Fitzgerald, RN,BSN,MS · contact · p-fitzgerald2@northwestern.edu · 312-695-1064
InvestigatorAdithya Bhat, MD · principal_investigator, Northwestern University
All locations (1)
Prentice Women's HospitalRecruiting
Chicago, Illinois, United States
Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients · TrialPath