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Clinical Trials/NCT04012151
NCT04012151
Active, not recruiting
Not Applicable

Arm and Finger Measurement for Blood Pressure Surveillance

KK Women's and Children's Hospital1 site in 1 country300 target enrollmentStarted: July 10, 2019Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
KK Women's and Children's Hospital
Enrollment
300
Locations
1
Primary Endpoint
Mid Arm circumference (MAC)(Left, Right)

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
21 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Mid Arm circumference (MAC)(Left, Right)

Time Frame: During antenatal visit (1-2 hours). One visit only

The circumference (cm) of the arm at the mid-point of the arm length as measured above, with the arm hanging by the side.

Arm length (Left, Right)

Time Frame: During antenatal visit (1-2 hours). One visit only

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.

Secondary Outcomes

  • Proximal arm circumference (Left, Right)(During antenatal visit (1-2 hours). One visit only)
  • Distal arm circumference (Left, Right)(During antenatal visit (1-2 hours). One visit only)
  • Finger circumference (Left, Right)(During antenatal visit (1-2 hours). One visit only)
  • Feedback on experiences of previous BP measurement(During antenatal visit (1-2 hours). One visit only)

Investigators

Sponsor
KK Women's and Children's Hospital
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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