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Multicenter comparative study of cardiac output measurement by non-invasive estimated continuous cardiac output (esCCO) and arterial pressure-based cardiac output (APCO) monitoring device in surgery patients under general anesthesia

Multicenter comparative study of cardiac output measurement by non-invasive estimated continuous cardiac output (esCCO) and arterial pressure-based cardiac output (APCO) in surgery patients under general anesthesia

No adverse events were reported in the study.

The bias and the precision by Bland-Altman plot are 0.07 and 0.97 L/min, respectively, and the percentage error was 48%. All calibration methods were compared using polar plot. Angular bias and radial limits of agreement were no greater than ±5 degree and ±30 degree respectively.

esCCO is as a clinically useful CO monitor as APCO, which is well validated.

European Society of Anaesthesiology 2017

Takashi Terada

Toho University Omori Medical Center

11-1, Omori-nishi 6-chome, Ota-ku, Tokyo

Masahiro Echigo

Nihon Kohden Corporation

11-2, Kusunokidai 1-chome, Tokorozawa, Saitama

+81-3-5996-8156

Masahiro_Echigo@mb1.nkc.co.jp

COMPLETED

April. 01, 2016

Observational

Multicenter, active concurrent control, intra-patient comparison

open(masking not used)

No

N/A

Eligible patients were expected to meet all of the following criteria:
1) patients undergoing planned surgery under general anesthesia
2) patients whose surgical operation is expected to last for at least 2 hours
3) patients undergoing surgical operation in the supine posture
4) patients already requiring IBP measurement
5) patients aged 20 years or older at the time of providing informed consent
6) patients having voluntarily provided written consent for participation in this study, based on full understanding after sufficient explanation

Patients who meet any of the following criteria were excluded from participating in this study.
1) patients having been considered "difficult to anesthetise" as specified in the Table of Points of Remuneration for Examination and Treatment L008 at preoperative examination
2) patients having been diagnosed to have any of the following findings at preoperative examination:
i) supraventricular rhythm irregularities including atrial fibrillation, atrial flutter and sinus arrhythmia
ii) bigeminy and trigeminy
iii) second- or third-degree atrioventricular block
3) patients requiring pacing during surgery
4) patients requiring postural change during surgery
5) patients requiring coronary artery bypass grafting without oxygenator
6) patients requiring artery clamp
7) patients in a condition of cardiac tamponade
8) patients with prior cardiopulmonary bypass surgery
9) patients with prior blood vessel prosthesis implantation
10) patients undergoing emergency operation
11) Patients inappropriate for this study in the judgment of the investigator and/or subinvestigator

Both

Surgery patients requiring hemodynamics management

Intervention type: Name of intervention: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen: detailes of teratment arms: Comparative intervention name: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:

APCO and esCCO values (calibrated with APCO and IBP) (Calibration 1)

i) esCCO (Calibration 1) and esCCO (calibrated with APCO and NIBP) (Calibration 2)
ii) esCCO (Calibration 1) and esCCO (calibrated with patient information and IBP) (Calibration 3)
iii) esCCO (Calibration 1) and esCCO (calibrated with patient information and NIBP) (Calibration 4)

Mar. 08, 2016