Arm and Finger Measurement for Blood Pressure Surveillance

Hypertension, Pregnancy-Induced Clinical Trial

— ARMFIN  

Official title:

Arm and Finger Measurement for Blood Pressure Surveillance

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04012151
• Other study ID #: ARMFIN
• Secondary ID: ANAESPRG19/012
• Status: Active, not recruiting
• Start date: July 10, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Accurate blood pressure (BP) measurement is critical in peripartum care. The cuff and bladder sizes affects the accuracy of BP measurement. Current international BP measurement recommendations are based on mid-arm circumference (MAC). However, evidence have shown the discrepancies between these sizes, leading to inaccuracy of BP measurement. This study will measure arm and finger size of 300 parturients in third trimester to determine whether the MAC, finger measurement or body mass index (BMI) is the best clinical predictor for non-standard cuff sizes for BP measurement.

Description:

Accurate blood pressure (BP) measurement plays an important role in peripartum care as it is essential in detecting hypertensive disorders in pregnancy and medical decision making during the pregnancy. The cuff and bladder size have been highlighted as an important factor affecting the accuracy of BP measurement. Current international BP measurement recommendations are based on mid-arm circumference (MAC) assuming the arm is cylindrical in shape. However, evidence have shown a mismatch between these sizes, leading to BP overestimation or underestimation in obese patients. This is because the shape of the arm is a truncated cone instead of a cylinder, and the cuff will expand irregularly during inflation thus yielding inaccurate BP measurements. This is especially evident in Asian pregnant patients whereby no available guideline can recommend a suitable cuff for parturients with different MAC. Nexfin is a finger cuff device that can be a suitable alternative BP measurement device for such patients. In this study 300 parturients will be recruited in third trimester and undergoing nonemergent caesarean section in KKH. Patients' arm and finger sizes will be measured, and their user experience on current practices on BP measurement. The arm measurements will help to identify the proportion of women that may require non-standard cuff sizes for BP measurement. A conicity index will be determined whether the MAC, finger measurement or BMI is the best clinical predictor. The finger measurements will also help to determine the proportion of women that may require non-standard cuff sizes on the Nexfin device for BP measurement. The knowledge gathered in this pilot study will be used to design future studies in which the accuracy of Nexfin will be compared with standard BP measurement, which in turn will improve BP detection, subsequent patient monitoring and satisfaction.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• American Society of Anaesthesiologists physical status 1 or 2 (ASA 1 or 2) parturients at 32 or more weeks of gestation

• Multiparous or nulliparous;

• Age 21-50 years old;

• Undergoing Caesarean section in our institution.

Exclusion Criteria:

• Emergent Caesarean section such that consent and measurements cannot be taken.

Related Conditions & MeSH terms

• Hypertension, Pregnancy-Induced

Intervention

Other:
• Physical measurement
Parturients of gestational week >= 32 weeks will have their arms and fingers measured to generate the conicity index.
• Cuff size fitting
Fit on arm cuff and finger cuff as selected by investigators based on the measurement.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (12)

Bonso E, Saladini F, Zanier A, Benetti E, Dorigatti F, Palatini P. Accuracy of a single rigid conical cuff with standard-size bladder coupled to an automatic oscillometric device over a wide range of arm circumferences. Hypertens Res. 2010 Nov;33(11):1186 — View Citation

Brown MA, Lindheimer MD, de Swiet M, Van Assche A, Moutquin JM. The classification and diagnosis of the hypertensive disorders of pregnancy: statement from the International Society for the Study of Hypertension in Pregnancy (ISSHP). Hypertens Pregnancy. 2001;20(1):IX-XIV. doi: 10.1081/PRG-100104165. No abstract available. — View Citation

Eley VA, Roberts L, Rickards L, Pelecanos A, Blackie A, Zhang C, Christensen R, Barrett HL. Arm and finger measurements in the third trimester: Implications for blood pressure measurement. Pregnancy Hypertens. 2018 Oct;14:105-109. doi: 10.1016/j.preghy.20 — View Citation

Fonseca-Reyes S, de Alba-Garcia JG, Parra-Carrillo JZ, Paczka-Zapata JA. Effect of standard cuff on blood pressure readings in patients with obese arms. How frequent are arms of a 'large circumference'? Blood Press Monit. 2003 Jun;8(3):101-6. doi: 10.1097 — 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

O'Brien E, Asmar R, Beilin L, Imai Y, Mallion JM, Mancia G, Mengden T, Myers M, Padfield P, Palatini P, Parati G, Pickering T, Redon J, Staessen J, Stergiou G, Verdecchia P; European Society of Hypertension Working Group on Blood Pressure Monitoring. European Society of Hypertension recommendations for conventional, ambulatory and home blood pressure measurement. J Hypertens. 2003 May;21(5):821-48. doi: 10.1097/00004872-200305000-00001. No abstract available. — 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, 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

Penaz J. Criteria for set point estimation in the volume clamp method of blood pressure measurement. Physiol Res. 1992;41(1):5-10. — View Citation

Perloff D, Grim C, Flack J, Frohlich ED, Hill M, McDonald M, Morgenstern BZ. Human blood pressure determination by sphygmomanometry. Circulation. 1993 Nov;88(5 Pt 1):2460-70. doi: 10.1161/01.cir.88.5.2460. No abstract available. — View Citation

Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ. Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Circulation. 2005 Feb 8;111(5):697-716. doi: 10.1161/01.CIR.0000154900.76284.F6. — View Citation

Wang J, Thornton JC, Russell M, Burastero S, Heymsfield S, Pierson RN Jr. Asians have lower body mass index (BMI) but higher percent body fat than do whites: comparisons of anthropometric measurements. Am J Clin Nutr. 1994 Jul;60(1):23-8. doi: 10.1093/ajc — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm length (Left, Right)	The distance (cm) between the tip of the acromion process to the tip of the olecranon process on the posterior aspect of the arm, with the elbow in the flexed position.	During antenatal visit (1-2 hours). One visit only
Primary	Mid Arm circumference (MAC)(Left, Right)	The circumference (cm) of the arm at the mid-point of the arm length as measured above, with the arm hanging by the side.	During antenatal visit (1-2 hours). One visit only
Secondary	Proximal arm circumference (Left, Right)	Arm circumference (cm) of the arm measured at the axilla, with the arm hanging by the side.	During antenatal visit (1-2 hours). One visit only
Secondary	Distal arm circumference (Left, Right)	The circumference (cm) at the elbow above the elbow crease, with the arm hanging by the side.	During antenatal visit (1-2 hours). One visit only
Secondary	Finger circumference (Left, Right)	The circumference (cm) of the mid-point of the middle phalanx of the middle finger will be measured with the hands placed flat on a table.	During antenatal visit (1-2 hours). One visit only
Secondary	Feedback on experiences of previous BP measurement	Participants will also respond to a three-point rating scale (Never, sometimes, always) about their experience of the procedures for previous BP measurement during the current pregnancy, with questions such as the length of time taken to obtain a reading, the need to change a cuff when taking BP, the need to take BP on the leg and whether the arm felt uncomfortable when taking blood pressure.	During antenatal visit (1-2 hours). One visit only