Validation of a new device for transcutaneous oxygen pressure recordings in real and simulated exercise tests

Measurement of transcutaneous oxygen pressure (tcpO2) is of interest in critical limb ischemia at rest and also during exercise in patients suffering proximal claudication or claudication of questionable origin. The recent commercialization of the computerized multiprobe-TCM400 device (Radiometer, Copenhagen, DK) appears attractive for exercise tests but comparison with the previous devices has not been reported. Indeed, the final endpoint for the physician is to be sure that a new apparatus will not interfere with the results observed in patients.

Using a 5 probe-TCM400 and 5 single probe-TCM3s, simultaneous recordings of tcpO2 were performed: 1) in vitro during 25 simulated exercises and 2) in vivo during exercise treadmill tests in 27 vascular patients. We analyzed resting (REST), minimal absolute (MIN) and DROP (limb-changes minus chest-changes) values. TcpO2 absolute and DROP profiles were analyzed through cross-correlation to detect response delays between the devices.

In simulated tests, the Pearson coefficient of correlation between TCM400 and TCM3 was r=0.99 for REST, MIN and minimal DROP. In treadmill tests, the Pearson coefficient of correlation between TCM400 and TCM3 was significantly higher with minimal DROP (r=0.88) than with REST (r=0.63) or MIN (r=0.7). A 15 s delay was observed with TCM3 as compared to TCM400 responses for both tcpO2 and DROP profiles. The rmax(2) of the cross-correlation was 0.74 and 0.67 for tcpO2 and DROP, respectively.

Our observations underline the limits of the clinical in vivo comparison of 2 transcutaneous devices. Despite the differences observed in absolute values during in vivo tests with simultaneous recordings (assumed to rely on physiological and not technical problems), we suggest that TCM400 is valid for exercise tests with the advantage of improved user interface, automatic memorization and integrated multiple probes of this newly commercially available apparatus.