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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Changi General Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pleural Effusion
• Ascites

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-27
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2023-02-21
• Last updated: 2024-01-03

Locations

1 site across 1 country: Singapore