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

Changi General Hospital

Status: Enrolling

Conditions: Pleural Effusion; Ascites

Treatments: Device: EFFIDRAIN; Device: Manual drainage system

Study type: Interventional

Funder types: Other

Identifiers

NCT05734729

EFFIDRAIN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Pleural Arm

Experimental group

Description:

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

Treatment:

Device: EFFIDRAIN

Device: Manual drainage system

Ascites arm

Experimental group

Description:

Patient's maximum volume is 3 litre per hour, not to exceed total 15 litres over 5 hours

Treatment:

Device: EFFIDRAIN

Device: Manual drainage system