Clinical Validation of Programmable Drain Fluid Regulator to Reduce Morbidity, Care Requirements, and Improve Outcomes

Sponsor

Changi General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05734729

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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:

We hypothesize that Effidrain can reduce the time that the subject requires a pleural or abdominal drain in-situ, compared to conventional care.
We 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.

Condition or Disease	Intervention/Treatment	Phase
Pleural Effusion Ascites	Device: EFFIDRAIN Device: Manual drainage system	N/A

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:

We hypothesize that Effidrain can reduce the time that the subject requires a pleural or abdominal drain in-situ, compared to conventional care.
We 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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Validation of Programmable Chest and Abdominal Drain Fluid Regulator to Reduce Morbidity, Care Requirements, and Improve Outcomes: First-In-Human Medical Device Study

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pleural Arm Patient's maximum volume is 1 litre per hour, not to exceed total 4 litres over 4 hours	Device: 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. Device: Manual drainage system 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	Device: 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. Device: Manual drainage system drainage systems required manual control and are unautomated; consequent unintended rapid intravascular and extravascular fluid shifts may result in clinical instability.

Arm

Intervention/Treatment

Experimental: Pleural Arm

Patient's maximum volume is 1 litre per hour, not to exceed total 4 litres over 4 hours

Device: 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.

Device: Manual drainage system

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

Device: EFFIDRAIN

Device: Manual drainage system

drainage systems required manual control and are unautomated; consequent unintended rapid intravascular and extravascular fluid shifts may result in clinical instability.

Outcome Measures

Primary Outcome Measures

demonstrate that the Effidrain can perform the function of pleural and ascites drainage in human subjects accurately and precisely [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.

Secondary Outcome Measures

Reduction in time that a subject requires a chest or abdominal drain in-situ [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.
Reduction in time required for post-procedure monitoring by healthcare workers [after 72 hours of usage per patient]
Further analysis involve quantifying the effect of Effidrain on health-related outcomes such as: Reduction in time that a subject requires a chest or abdominal drain in-situ Reduction in time required for post-procedure monitoring by healthcare workers Inpatient hospitalisation days The median times for the variables above would be compared between interventional and control groups using Mann Whitney U tests
Improvement in cost-effectiveness of care for each inpatient episode of pleural effusion or ascites that requires drainage. [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: Number of patients requiring pleural and abdominal drainage in Changi General Hospital per year Costs of developing the Effidrain from hospital perspective Costs of maintaining the Effidrain from hospital perspective (including man-hours and actual expenditure incurred by the hospital) Man-hours and unit cost of man-hours in conducting pleural and abdominal drainage using the Effidrain Man-hours and unit cost of man-hours in conducting pleural and abdominal drainage using manual drainage Length of stay of patients using the Effidrain and the manual drainage

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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