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

Launched by CHANGI GENERAL HOSPITAL · Feb 9, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new medical device called the Effidrain, which aims to improve the way fluid is drained from the body in patients with conditions like pleural effusion (fluid around the lungs) and ascites (fluid in the abdomen). The study will include 120 participants, and it will compare the effectiveness of the Effidrain device to traditional manual drainage methods. Researchers hope that using Effidrain will not only drain fluid more accurately but also reduce the time patients need to have the drains in place and lessen the amount of care required from healthcare staff.

To participate in this trial, you must be an adult aged 21 or older with a significant amount of fluid that needs to be drained. This could be if you have a pleural effusion taking up more than one-third of your chest space or if you expect to drain more than a liter of fluid from your abdomen. Participants will be randomly assigned to either use the Effidrain device or the standard manual drainage system. Throughout the trial, both participants and nurses will fill out questionnaires to share their experiences. The trial is currently recruiting, and everyone involved will be contributing to important research that could lead to better care for patients needing fluid drainage.

Gender

ALL

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