Key result
STAN monitoring shows severe limitations detecting hypoxemia, losing ST-waveforms during ~62% of umbilical cord occlusion.
Why the study?
Does the STAN device accurately detect hypoxemia in a fetal sheep model exposed to prolonged umbilical cord occlusion?
Does the STAN device accurately detect hypoxemia in a fetal sheep model exposed to prolonged umbilical cord occlusion?
Absolute Event Rate: 62% vs 14%
p-value: p=<0.05
The STAN device demonstrated significant signal processing limitations, failing to assess ST-waveforms during 62% of prolonged umbilical cord occlusion in a fetal sheep model.
STAN limitations in fetal sheep hypoxemia model caution clinical reliance; leaves open need for device refinements and human validation.
INTRODUCTION: The inconclusive clinical results for ST-waveform analysis (STAN) in detecting fetal hypoxemia may be caused by the signal processing of the STAN-device itself. We assessed the performance of a clinical STAN device in signal processing and in detecting hypoxemia in a fetal sheep model exposed to prolonged umbilical cord occlusion (UCO). METHODS: Eight fetal lambs were exposed to 25 minutes of UCO. ECG recordings were analyzed during a baseline period and during UCO. STAN-event rates and timing of episodic T/QRS rise, baseline T/QRS rise and the occurrence of biphasic ST-waveforms, as well as signal loss, were assessed. RESULTS: During baseline conditions of normoxemia, a median of 40 (IQR, 25-70) STAN-events per minute were detected, compared to 10 (IQR, 2-22) during UCO. During UCO STAN-events were detected in five subjects within 10 minutes and in six subjects after 18 minutes, respectively. Two subjects did not generate any STAN-event during UCO. Biphasic ST event rate was reduced during UCO (median 0, IQR 0-5), compared to baseline (median 32, IQR, 6-55). ST-waveforms could not be assessed in 62% of the recording time during UCO, despite a good quality of the ECG signal. CONCLUSIONS: The STAN device showed limitations in detecting hypoxemia in fetal sheep after prolonged UCO. The STAN device produced high false positive event rates during baseline and did not detect T/QRS changes adequately after prolonged fetal hypoxemia. During 14% of baseline and 62% of the UCO period, the STAN-device could not process the ECG signal, despite its good quality. Resolving these issues may improve the clinical performance of the STAN device.
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Andriessen et al. (2018) studied Fetal hypoxic distress (n=8). Prolonged umbilical cord occlusion vs. Baseline (normoxemia) was evaluated on ST waveform signal loss (% of recording time) (p=<0.05). The STAN device showed severe limitations in detecting hypoxemia, with ST-waveforms unassessable in 62% of the recording time during umbilical cord occlusion compared to 14% during baseline.
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