G Duclos1, A Hili2, N Resseguier3, C Kelway4, M Haddam2, A Bourgoin2, X Carcopino5, L Zieleskiewicz6, M Leone7. 1. Aix Marseille University, Department of Anaesthesia and Intensive Care, Assistance Publique Hôpitaux de Marseille, University Hospital of Marseille, Marseille, France. Electronic address: Gary.duclos@ap-hm.fr. 2. Aix Marseille University, Department of Anaesthesia and Intensive Care, Assistance Publique Hôpitaux de Marseille, University Hospital of Marseille, Marseille, France. 3. Aix Marseille University, Support Unit for Clinical Research and Economic Evaluation, Assistance Publique - Hôpitaux de Marseille, University Hospital of Marseille, Marseille, France. 4. Service de réanimation polyvalente, Hôpital sainte Musse, Toulon, France. 5. Department of Obstetrics and Gynecology, Gynépôle, Assistance Publique Hôpitaux de Marseille, Marseille, France. 6. Aix Marseille University, INSERM, INRA, C2VN, Marseille, France. 7. Clinical Investigation Center 1409, Aix-Marseille University, Assistance Publique Hôpitaux de Marseille, Marseille, France.
Abstract
BACKGROUND: We assessed the validity of Clearsight™ as a non-invasive cardiac output and stroke volume monitoring device, comparing it with transthoracic echocardiography measurements during the third trimester of pregnancy. METHODS: Measurements obtained from Clearsight™ were compared with those from echocardiography as the gold standard. The precision and accuracy of the Clearsight™ was measured using the Bland and Altman method. Clinical agreement with echocardiography was assessed using the agreement tolerability index. RESULTS: Measurements were recorded from 44 pregnant women with a median [IQR range] gestational age of 33 [30-37] weeks. We found that Clearsight™ measurements presented a systematic overestimation of cardiac output, with mean bias [CI 95%] of 2.7 [2.3-3.0] L/min, with limits of agreement of -0.1 to 5.4 L/min. It overestimated stroke volume, with a bias of 29.5 [25.0-33.4] mL and a limit of agreement of -1.6 to 60.1 mL. In addition, the analysis of cardiac output showed a percentage of error of 41% and intra-class correlation [CI 95%] of 0.37 [0.17 to 0.53, P <0.001]. For stroke volume, the percentage of error was 40% and intra-class correlation 0.16 [-0.1 to 0.34; P=0.27]. We found that agreement tolerability index scores were unacceptable. We evaluated the ability of the device to track changes in cardiac output by inducing a left lateral decubitus position, but the analysis was inconclusive. CONCLUSION: The agreement between Clearsight™ and the echocardiography measurements of cardiac output and stroke volume were not within an acceptable range in the third trimester of pregnancy.
BACKGROUND: We assessed the validity of Clearsight™ as a non-invasive cardiac output and stroke volume monitoring device, comparing it with transthoracic echocardiography measurements during the third trimester of pregnancy. METHODS: Measurements obtained from Clearsight™ were compared with those from echocardiography as the gold standard. The precision and accuracy of the Clearsight™ was measured using the Bland and Altman method. Clinical agreement with echocardiography was assessed using the agreement tolerability index. RESULTS: Measurements were recorded from 44 pregnant women with a median [IQR range] gestational age of 33 [30-37] weeks. We found that Clearsight™ measurements presented a systematic overestimation of cardiac output, with mean bias [CI 95%] of 2.7 [2.3-3.0] L/min, with limits of agreement of -0.1 to 5.4 L/min. It overestimated stroke volume, with a bias of 29.5 [25.0-33.4] mL and a limit of agreement of -1.6 to 60.1 mL. In addition, the analysis of cardiac output showed a percentage of error of 41% and intra-class correlation [CI 95%] of 0.37 [0.17 to 0.53, P <0.001]. For stroke volume, the percentage of error was 40% and intra-class correlation 0.16 [-0.1 to 0.34; P=0.27]. We found that agreement tolerability index scores were unacceptable. We evaluated the ability of the device to track changes in cardiac output by inducing a left lateral decubitus position, but the analysis was inconclusive. CONCLUSION: The agreement between Clearsight™ and the echocardiography measurements of cardiac output and stroke volume were not within an acceptable range in the third trimester of pregnancy.
Authors: Luciano Frassanito; Pietro Paolo Giuri; Francesco Vassalli; Alessandra Piersanti; Alessia Longo; Bruno Antonio Zanfini; Stefano Catarci; Anna Fagotti; Giovanni Scambia; Gaetano Draisci Journal: J Clin Monit Comput Date: 2021-10-07 Impact factor: 1.977
Authors: Philipp Helmer; Daniel Helf; Michael Sammeth; Bernd Winkler; Sebastian Hottenrott; Patrick Meybohm; Peter Kranke Journal: J Clin Med Date: 2022-08-02 Impact factor: 4.964