Investigation of clinically acceptable agreement between two methods of automatic measurement of limb occlusion pressure: a randomised trial

Abstract

Background: Development of automatic, pneumatic tourniquet technology and use of personalised tourniquet pressures has improved the safety and accuracy of surgical tourniquet systems. Personalisation of tourniquet pressure requires accurate measurement of limb occlusion pressure (LOP), which can be measured automatically through two different methods. The 'embedded LOP' method measures LOP using a dual-purpose tourniquet cuff acting as both patient sensor and pneumatic effector. The 'distal LOP' method measures LOP using a distal sensor applied to the patient's finger or toe of the operating limb, using photoplethysmography to detect volumetric changes in peripheral blood circulation. The distal LOP method has been used clinically for many years; the embedded LOP method was developed recently with several advantages over the distal LOP method. While both methods have clinically acceptable accuracy in comparison to LOP measured using the manual Doppler ultrasound method, these two automatic methods have not been directly compared. The purpose of this study is to investigate if the embedded and distal methods of LOP measurement have clinically acceptable agreement. The differences in pairs of LOP measurement in the upper and lower limbs of 81 healthy individuals were compared using modified Bland and Altman analysis. In surgery, it is common for cuff pressure to deviate from the pressure setpoint due to limb manipulation. Surgical tourniquet systems utilise a ± 15 mmHg pressure alarm window, whereby if the cuff pressure deviates from the pressure setpoint by > 15 mmHg, an audiovisual alarm is triggered. Therefore, if the difference (bias) ± SE, 95% CI of the bias and SD of differences ± SE in LOP measurement between the embedded and distal methods were all within ±15 mmHg, this would demonstrate that the two methods have clinically acceptable agreement.

Results: LOP measurement using the embedded LOP method was - 0.81 ± 0.75 mmHg (bias ± standard error) lower than the distal LOP method. The 95% confidence interval of the bias was - 2.29 to 0.66 mmHg. The standard deviation of the differences ± standard error was 10.35 ± 0.49 mmHg. These results show that the embedded and distal methods of LOP measurement demonstrate clinically acceptable agreement.

Conclusions: The findings of this study demonstrate clinically acceptable agreement between the embedded and distal methods of LOP measurement. The findings support the use of the embedded LOP method of automatic LOP measurement using dual-purpose tourniquet cuffs to enable accurate, effective and simple prescription of personalised tourniquet cuff pressures in a clinical setting.

Keywords: Limb occlusion pressure; Personalised; Tourniquet; Tourniquet safety.

Fig. 1

Randomisation procedure for limb and measurement order

Fig. 2

Overview of possible protocols following randomisation

Fig. 3

Bland-Altman plot of LOP differences