Clinical Validation of Programmable Drain Fluid Regulator to Reduce Morbidity, Care Requirements, and Improve Outcomes
NCT ID: NCT05734729
Last Updated: 2024-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-02-27
2025-09-30
Brief Summary
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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:
1. The investigators hypothesize that Effidrain can reduce the time that the subject requires a pleural or abdominal drain in-situ, compared to conventional care.
2. 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.
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Detailed Description
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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:
1. The investigators hypothesize that Effidrain can reduce the time that the subject requires a pleural or abdominal drain in-situ, compared to conventional care.
2. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pleural Arm
Patient's maximum volume is 1 litre per hour, not to exceed total 4 litres over 4 hours
EFFIDRAIN
. 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.
Manual drainage system
drainage systems required manual control and are unautomated; consequent unintended rapid intravascular and extravascular fluid shifts may result in clinical instability.
Ascites arm
Patient's maximum volume is 3 litre per hour, not to exceed total 15 litres over 5 hours
EFFIDRAIN
. 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.
Manual drainage system
drainage systems required manual control and are unautomated; consequent unintended rapid intravascular and extravascular fluid shifts may result in clinical instability.
Interventions
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EFFIDRAIN
. 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.
Manual drainage system
drainage systems required manual control and are unautomated; consequent unintended rapid intravascular and extravascular fluid shifts may result in clinical instability.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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Changi General Hospital
OTHER
Responsible Party
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Jessica Quah Li Shan
Consultant
Locations
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Changi General Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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CTRU
Role: primary
Other Identifiers
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EFFIDRAIN
Identifier Type: -
Identifier Source: org_study_id
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