Surgery patients requiring hemodynamics management
Conditions
Interventions
Intervention type:
Name of intervention:
Dose form / Japanese Medical Device Nomenclature:
Route of administration / Site of application:
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Dosing frequency / Frequency of use:
Sponsors
Nihon Kohden Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| APCO and esCCO values (calibrated with APCO and IBP) (Calibration 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactMasahiro Echigo
Nihon Kohden Corporation
Outcome results
None listed