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Clinical validation of a digital transcutaneous PCO2/SpO2 ear sensor in adult patients after cardiac surgery


Baulig, Werner; Schütt, Philipp; Roth, Hans R; Hayoz, Josef; Schmid, Edith R (2007). Clinical validation of a digital transcutaneous PCO2/SpO2 ear sensor in adult patients after cardiac surgery. Journal of Clinical Monitoring and Computing, 21(5):303-309.

Abstract

Objective: The aim of this study was to validate the V-Sign digital sensor (SenTec AG, Therweil, Switzerland) for combined noninvasive assessment of pulse oxymetric oxygen saturation (SpO2) and transcutaneous carbon dioxide tension (PtcCO2) in adults after cardiac surgery. Methods: In twenty one patients, aged 51-86years, simultaneous measurements of blood gases with the V-Sign Sensor and with two Nellcor Durasensors (model DS-100A), one at the opposite earlobe and one with a finger clip, were compared first during hyper-, normo- and hypocapnia and at different pulse rates using a pacemaker, and then at 2-h intervals up to 8h. Agreement was assessed by Bland-Altman analysis. Results: PtcCO2 data of three patients were excluded because of calibration failure of the device. Median (range) PtcCO2 for the remaining patients was 5.49 (3.3-7.6) kPa and arterial carbon dioxide tension (PaCO2) was 5.43 (3.61-7.41) kPa. Corresponding mean bias was +0.05kPa and limits of agreement (LOA) were −1.2/+1.3kPa. During normo- and hypoventilation, mean bias was good at +0.02 and +0.04kPa respectively, but limits of agreement were poor at −0.67/+0.69 and −0.81/+0.88kPa. In 10 patients, an initial overshoot of PtcCO2 was observed. Mean bias of SpO2 and pulse rate was close to zero (−1.5% and +0.001bpm respectively), but limits of agreement were unacceptably high (−21.4/+18.4% and −22.3/+22.3bpm). Conclusions: In the present state of development the SenTeC Digital monitor V-Sign device has serious limitations. Additional efforts are necessary to eliminate calibration failures and the initial overshoot of PtcCO2 as well as to improve detection of SpO2 and pulse rate

Abstract

Objective: The aim of this study was to validate the V-Sign digital sensor (SenTec AG, Therweil, Switzerland) for combined noninvasive assessment of pulse oxymetric oxygen saturation (SpO2) and transcutaneous carbon dioxide tension (PtcCO2) in adults after cardiac surgery. Methods: In twenty one patients, aged 51-86years, simultaneous measurements of blood gases with the V-Sign Sensor and with two Nellcor Durasensors (model DS-100A), one at the opposite earlobe and one with a finger clip, were compared first during hyper-, normo- and hypocapnia and at different pulse rates using a pacemaker, and then at 2-h intervals up to 8h. Agreement was assessed by Bland-Altman analysis. Results: PtcCO2 data of three patients were excluded because of calibration failure of the device. Median (range) PtcCO2 for the remaining patients was 5.49 (3.3-7.6) kPa and arterial carbon dioxide tension (PaCO2) was 5.43 (3.61-7.41) kPa. Corresponding mean bias was +0.05kPa and limits of agreement (LOA) were −1.2/+1.3kPa. During normo- and hypoventilation, mean bias was good at +0.02 and +0.04kPa respectively, but limits of agreement were poor at −0.67/+0.69 and −0.81/+0.88kPa. In 10 patients, an initial overshoot of PtcCO2 was observed. Mean bias of SpO2 and pulse rate was close to zero (−1.5% and +0.001bpm respectively), but limits of agreement were unacceptably high (−21.4/+18.4% and −22.3/+22.3bpm). Conclusions: In the present state of development the SenTeC Digital monitor V-Sign device has serious limitations. Additional efforts are necessary to eliminate calibration failures and the initial overshoot of PtcCO2 as well as to improve detection of SpO2 and pulse rate

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:National licences > 142-005
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:8 September 2007
Deposited On:27 Nov 2018 16:18
Last Modified:24 Sep 2019 23:44
Publisher:Springer
ISSN:1387-1307
OA Status:Green
Publisher DOI:https://doi.org/10.1007/s10877-007-9088-6
Related URLs:https://www.swissbib.ch/Search/Results?lookfor=nationallicencespringer101007s1087700790886 (Library Catalogue)
PubMed ID:17701383

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