Evaluation study of the peripheral infusion leakage in infants and children: ivWatch

JRCT ID: jRCTs062210017

Registered date:22/06/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: post surgical children
• Date of first enrollment: 22/06/2021
• Target sample size: 100
• Study type: Interventional

Intervention(s)

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 through an optical sensor cable.
If multiple PVCs are implanted, the principal investigator or subspecialist will select one of the PVCs implanted at the end of the elbow for the upper extremity and at the end of the knee for the lower extremity that is more suitable for intervention.Contraindicated drugs (dark, colored or cloudy drug solutions, including blood transfusions) are administered priority from routes other than PVC selected for observation.
In addition to detecting extravascular infiltration and leakage of fluids and medications from the PVCs under normal medical supervision, data will be collected on the detection of the ivWatch wearer. The ivWatch detection alarm should not be visually or auditory perceptible to health care workers after the operation check is confirmed when the ivWatch was set.
Multiple interventions for the same study subject with different PVC implantation sites will be allowed. However, only one intervention will be performed per PCICU admission. If the patient is within the 30-day tolerance after consent is obtained, consent will not be obtained again, and only a new case enrollment will be made for observation.

Outcome(s)

• Primary Outcome: Calculate the difference in time between detection by the healthcare worker's usual management method and detection by ivWatch.

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 4age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kanazawa Tomoyuki
• Secondary Sponsor: TERUMO corporation