Clinical trial NCT05734729: Clinical Validation of Programmable Drain Fluid Regulator to Reduce Morbidity, Care Requirements, and Improve Outcomes
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pleural Effusion
Ascites
Keywords: Medical device
Pleural effusion
Ascites
Drainage
Novel
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

  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.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: demonstrate that the Effidrain can perform the function of pleural and ascites drainage in human subjects accurately and precisely
timeFrame: after 72 hours of usage per patient
Secondary outcomes:
measure: Reduction in time that a subject requires a chest or abdominal drain in-situ
timeFrame: Total of 4 hours for Pleural arm and 5 hours for Ascites arm
measure: Reduction in time required for post-procedure monitoring by healthcare workers
timeFrame: after 72 hours of usage per patient
measure: Improvement in cost-effectiveness of care for each inpatient episode of pleural effusion or ascites that requires drainage.
timeFrame: after 72 hours of usage per patient
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
References: