- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05734729
Clinical Validation of Programmable Drain Fluid Regulator to Reduce Morbidity, Care Requirements, and Improve Outcomes
Clinical Validation of Programmable Chest and Abdominal Drain Fluid Regulator to Reduce Morbidity, Care Requirements, and Improve Outcomes: First-In-Human Medical Device Study
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:
- The investigators hypothesize that Effidrain can reduce the time that the subject requires a pleural or abdominal drain in-situ, compared to conventional care.
- The investigators hypothesize that the time required for healthcare workers to perform post-procedure monitoring for subjects that require pleural or abdominal drainage using Effidrain, would be reduced compared to conventional care. The effect of technology on physician and nursing hours required for drain care, and cost-effectiveness of the intervention will be studied
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- The investigators hypothesize that Effidrain can reduce the time that the subject requires a pleural or abdominal drain in-situ, compared to conventional care.
- The investigators hypothesize that the time required for healthcare workers to perform post-procedure monitoring for subjects that require pleural or abdominal drainage using Effidrain, would be reduced compared to conventional care. The effect of technology on physician and nursing hours required for drain care, and cost-effectiveness of the intervention will be studied.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jessica Quah Lishan
- Phone Number: 6620 9679 7074
- Email: jessica.quah.l.s@singhealth.com.sg
Study Contact Backup
- Name: CTRU Mainline
- Phone Number: 7818 64267818
- Email: CTRU@cgh.com.sg
Study Locations
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-
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Singapore, Singapore
- Recruiting
- Changi General Hospital
-
Contact:
- CTRU
- Phone Number: 64267818
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pleural effusion or ascites as the primary indication for chest or abdominal drain insertion
- Expected ascites drainage volume more than 1 Litre or at least moderate sized pleural effusion (occupying more than one-third hemi-thorax)
- uncomplicated chest or abdominal drain insertion
- Adults aged 21 years, able to provide (or surrogate able to provide) consent.
Exclusion Criteria:
- Vulnerable persons, including but not limited to, pregnant women and prisoners
- Hemodynamic instability, defined by heart rate more than 120 beats per minutes and blood pressure less than systolic 90mmHg
- Haemothorax or Haemoperitoneum
- pneumothorax or pneumoperitoneum
- chest or abdominal drain insertion => 48 hours with more than estimated 50% of total body cavity fluid drained
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pleural Arm
Patient's maximum volume is 1 litre per hour, not to exceed total 4 litres over 4 hours
|
. 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.
drainage systems required manual control and are unautomated; consequent unintended rapid intravascular and extravascular fluid shifts may result in clinical instability.
|
Experimental: Ascites arm
Patient's maximum volume is 3 litre per hour, not to exceed total 15 litres over 5 hours
|
. 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.
drainage systems required manual control and are unautomated; consequent unintended rapid intravascular and extravascular fluid shifts may result in clinical instability.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
demonstrate that the Effidrain can perform the function of pleural and ascites drainage in human subjects accurately and precisely
Time Frame: after 72 hours of usage per patient
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in time that a subject requires a chest or abdominal drain in-situ
Time Frame: Total of 4 hours for Pleural arm and 5 hours for Ascites arm
|
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
|
Reduction in time required for post-procedure monitoring by healthcare workers
Time Frame: after 72 hours of usage per patient
|
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.
Time Frame: after 72 hours of usage per patient
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFFIDRAIN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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