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The goal of this Effidrain first-in-human medical device trial is to improve the outcomes of patients with pleural effusions and ascites.
The main aims are:
The primary aim of this first-in-man device pivotal study (n=120) is to demonstrate that the body fluid drain regulator can perform the function of pleural or ascites drainage, accurately and precisely.
The secondary aims are related to explore the effects of Effidrain on health-related outcomes:
Participants will be randomized to control and intervention group. Control group will be receiving treatment using manual drainage system while intervention group will be using Effidrain machine.
Participants and Nurses from both control and intervention group will be asked to fill participant/nurses questionnaire form respectively.
The mission of the Effidrain first-in-human medical device trial is to improve the outcomes of patients with pleural effusions and ascites.
The primary aim of this first-in-man device pivotal study (n=120) is to demonstrate that the body fluid drain regulator can perform the function of pleural or ascites drainage, accurately and precisely.
The primary hypothesis is that the group of patients with device drainage intervention would be able to demonstrate actual fluid drainage not more than 110% of the physician-prescribed drainage volume and time.
The secondary aims are related to explore the effects of Effidrain on health-related outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pleural Arm | Experimental | Patient's maximum volume is 1 litre per hour, not to exceed total 4 litres over 4 hours |
|
| Ascites arm | Experimental | Patient's maximum volume is 3 litre per hour, not to exceed total 15 litres over 5 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EFFIDRAIN | Device | . Effidrain is a progammable, light-weight, portable drain regulator that can control the rate and volume of body fluid being drained, while empowering the user with information on dynamic changes of pressure within the body cavity being drainged. It is able to adapt to existing drainage systems via a standard medical luer taper connector, and comes with a failsafe system to alert users of drainage irregularities. |
| Measure | Description | Time Frame |
|---|---|---|
| demonstrate that the Effidrain can perform the function of pleural and ascites drainage in human subjects accurately and precisely | A session completed by the medical device not exceeding 10% volume of the physican precribed drainage volume is considered a success and scored as completely meeting device efficacy criteria. A session completed by the medical device not exceeding 25% volume of the physican precribed drainage volume is considered a success and scored as partially meeting device efficacy criteria. A session completed by the medical device exceeding 25% volume of the physican precribed drainage volume is considered a failure and scored as not meeting device efficacy criteria. | after 72 hours of usage per patient |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in time that a subject requires a chest or abdominal drain in-situ | Mean difference between of physician-planned drainage volume and time required, vs actual drainage volume and time, in both intervention and control arms will be analysed using T-tests. | Total of 4 hours for Pleural arm and 5 hours for Ascites arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Quah Lishan | Contact | 9679 7074 | 6620 | jessica.quah.l.s@singhealth.com.sg |
| CTRU Mainline | Contact | 64267818 | 7818 | CTRU@cgh.com.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Recruiting | Singapore | Singapore |
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| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| D001201 | Ascites |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Manual drainage system | Device | drainage systems required manual control and are unautomated; consequent unintended rapid intravascular and extravascular fluid shifts may result in clinical instability. |
|
| Reduction in time required for post-procedure monitoring by healthcare workers |
Further analysis involve quantifying the effect of Effidrain on health-related outcomes such as:
|
| after 72 hours of usage per patient |
| Improvement in cost-effectiveness of care for each inpatient episode of pleural effusion or ascites that requires drainage. | To estimate the costs, the following cost and probabilities data will be extracted from the different databases, including the hospital's electronic database:
| after 72 hours of usage per patient |