post surgical children
Conditions
Interventions
After surgery in the PCICU of Okayama University Hospital, patients with implanted PVCs will be fitted with ivWatch, and extravascular invasion and leakage of PVCs will be measured by reflected light
Sponsors
Kanazawa Tomoyuki
TERUMO corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Cjildren scheduled to be admitted to the PCICU after surgery at Okayama University Hospital between the Ethics Committee approval and September 30th, 2022, who have an indwelling peripheral venous catheter will be eligible. (2) Children weighing 2.5 kg or more at the time consent is obtained. (3) Children under 4 years of age at the time of obtaining consent (4) Children who have agreed to participate in the study by parents or gardians If the selection criteria are met again within 30 days of obtaining consent for this study, the patient may be re-enrolled without obtaining consent. However, the site of PVC should be different from the first time.
Exclusion criteria
Exclusion criteria: (1) Chidren with skin symptoms (severe dermatitis, burns, epidermolysis bullosa, or urticaria), scar and bruise. (2) Other children who are deemed unsuitable as research subjects by the principal investigator or sub-researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Calculate the difference in time between detection by the healthcare worker's usual management method and detection by ivWatch. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Incidence of extravascular infiltration/leakage when ivWatch is used Calculate the percentage of extravascular invasion/leakage numbers detected by ivWatch among all observed cases. 2) Sensitivity of ivWatch. Calculate the percentage of the number of extravascular infiltrates/leaks detected by ivWatch prior to the healthcare worker's confirmation of the number of extravascular infiltrates/leaks confirmed by the healthcare worker's. Also calculate the percentage of the number of extravascular infiltrates/leaks detected by ivWatch among the number of extravascular infiltrates/leaks confirmed by the healthcare worker's, regardless of before or after. 3) Specificity and accuracy of ivWatch The number of extravascular infiltrates/leaks not identified by the healthcare worker's is assumed to be the actual number of extravascular infiltrates/leaks that did not occur, and the specificity and accuracy of ivWatch is calculated. Specificity is defined as the ratio of the number of extravascular infiltrates/leaks not detected by ivWatch to the number of extravascular infiltrates/leaks not detected by the healthcare worker's, and accuracy is defined as the ratio of the number of extravascular infiltrates/leaks detected by ivWatch to the number of extravascular infiltrates/leaks confirmed by the healthcare worker's. 4) Other additional analysis may be made based on the findings during implementation of ivWatch functionality and usability. | — |
Contacts
Public ContactTomoyuki Kanazawa
Okayama University Hospital
Outcome results
None listed