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

Obesity Clinical Trial

Official title:

Evaluation of the Agreement Between Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06466161
• Other study ID #: STU00221793
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: June 2024
• Source: Northwestern University
• Contact: Adithya Bhat, MD
• Phone: 312-472-3585
• Email: adithya.bhat[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: September 1, 2026
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced
• Obesity

Intervention

Device:
• Upper Arm Cylindrical Blood Pressure Cuff
In Group 1, the upper arm cylindrical cuff is inflated first, followed by inflation of the forearm conical cuff.
• Forearm Conical Blood Pressure Cuff
In Group 2, the forearm conical cuff is inflated first, followed by inflation of the upper arm cylindrical cuff.

Locations

Country	Name	City	State
United States	Prentice Women's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (24)

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Bicocca MJ, Mendez-Figueroa H, Chauhan SP, Sibai BM. Maternal Obesity and the Risk of Early-Onset and Late-Onset Hypertensive Disorders of Pregnancy. Obstet Gynecol. 2020 Jul;136(1):118-127. doi: 10.1097/AOG.0000000000003901. — View Citation

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Hersh LT, Sesing JC, Luczyk WJ, Friedman BA, Zhou S, Batchelder PB. Validation of a conical cuff on the forearm for estimating radial artery blood pressure. Blood Press Monit. 2014 Feb;19(1):38-45. doi: 10.1097/MBP.0000000000000011. — View Citation

Kho CL, Brown MA, Ong SL, Mangos GJ. Blood pressure measurement in pregnancy: the effect of arm circumference and sphygmomanometer cuff size. Obstet Med. 2009 Sep;2(3):116-20. doi: 10.1258/om.2009.090017. Epub 2009 Sep 1. — View Citation

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Mauck GW, Smith CR, Geddes LA, Bourland JD. The meaning of the point of maximum oscillations in cuff pressure in the indirect measurement of blood pressure--part ii. J Biomech Eng. 1980 Feb;102(1):28-33. doi: 10.1115/1.3138195. — View Citation

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Palatini P, Asmar R. Cuff challenges in blood pressure measurement. J Clin Hypertens (Greenwich). 2018 Jul;20(7):1100-1103. doi: 10.1111/jch.13301. — View Citation

Palatini P, Benetti E, Fania C, Malipiero G, Saladini F. Rectangular cuffs may overestimate blood pressure in individuals with large conical arms. J Hypertens. 2012 Mar;30(3):530-6. doi: 10.1097/HJH.0b013e32834f98a0. — View Citation

Palatini P, Benetti E, Fania C, Saladini F. Only troncoconical cuffs can provide accurate blood pressure measurements in people with severe obesity. J Hypertens. 2019 Jan;37(1):37-41. doi: 10.1097/HJH.0000000000001823. — View Citation

Palatini P, Parati G. Blood pressure measurement in very obese patients: a challenging problem. J Hypertens. 2011 Mar;29(3):425-9. doi: 10.1097/HJH.0b013e3283435b65. No abstract available. — View Citation

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Stergiou GS, Alpert B, Mieke S, Asmar R, Atkins N, Eckert S, Frick G, Friedman B, Grassl T, Ichikawa T, Ioannidis JP, Lacy P, McManus R, Murray A, Myers M, Palatini P, Parati G, Quinn D, Sarkis J, Shennan A, Usuda T, Wang J, Wu CO, O'Brien E. A Universal Standard for the Validation of Blood Pressure Measuring Devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement. Hypertension. 2018 Mar;71(3):368-374. doi: 10.1161/HYPERTENSIONAHA.117.10237. Epub 2018 Jan 31. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, an average of 1 year
Primary	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.	Through study completion, an average of 1 year
Secondary	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.	Through study completion, an average of 1 year
Secondary	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).	Through study completion, an average of 1 year