Arm and Finger Measurement for Blood Pressure Surveillance

NCT ID: NCT04012151

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-10
• Study Completion Date: 2026-12-31

Brief 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.

Detailed 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.

Conditions

Hypertension, Pregnancy-Induced

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pregnant cohort

Parturients of gestational age \>= 32 weeks will have measurements of arm length, MAC, proximal arm circumference, distal arm circumference, finger circumference to generate the conicity index.

Physical measurement

Intervention Type: OTHER

Parturients of gestational week \>= 32 weeks will have their arms and fingers measured to generate the conicity index.

Cuff size fitting

Intervention Type: OTHER

Fit on arm cuff and finger cuff as selected by investigators based on the measurement.

Interventions

Physical measurement

Parturients of gestational week \>= 32 weeks will have their arms and fingers measured to generate the conicity index.

Intervention Type: OTHER

Cuff size fitting

Fit on arm cuff and finger cuff as selected by investigators based on the measurement.

Intervention Type: OTHER

Other Intervention Names

Measurement of fingers and arms; Cuff fitting for arm and finger

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Farida Ithnin, MMED (Anaes)

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

KK Women's and Children's Hospital

Singapore, , Singapore

Countries

Singapore

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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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.2018.09.002. Epub 2018 Sep 5.

Reference Type: RESULT

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Reference Type: RESULT

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Lim MJ, Tan CW, Tan HS, Sultana R, Eley V, Sng BL. Correlation of patient characteristics with arm and finger measurements in Asian parturients: a preliminary study. BMC Anesthesiol. 2020 Aug 31;20(1):218. doi: 10.1186/s12871-020-01131-6.

Reference Type: DERIVED

PMID: 32867679 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ANAESPRG19/012

Identifier Type: OTHER

Identifier Source: secondary_id

ARMFIN

Identifier Type: -

Identifier Source: org_study_id