A stage 3 trial will evaluate a negative pressure system’s effectiveness in capturing dangerous aerosols during bronchoscopies.
RT’s Three Key Takeaways:
- The clinical trial aims to assess the effectiveness of a portable negative pressure system in capturing aerosol emissions during bronchoscopic procedures, potentially reducing the risk of airborne infections for medical personnel.
- The randomized controlled trial will enroll 80 patients in a 1,000-bed tertiary facility over three months, providing data on the system’s performance in a real-world medical environment.
- Beyond bronchoscopies, the negative pressure system can be used in various medical procedures, including intubation and endoscopy.
SafER Medical Products LLC has announced a stage 3 clinical trial evaluating the SafER negative pressure system in reducing aerosol emissions during bronchoscopic procedures.
Bronchoscopy is known to be an aerosol-generating procedure and produces plumes of microscopic particles, some of which may carry infectious airborne organisms that can then be inhaled by medical personnel in attendance and subsequently pose a high risk of those medical staff contracting the disease.
“Our goal since the beginning of the pandemic has been to create a safer work environment for our friends and colleagues who are exposed to dangerous pathogens when performing aerosol-generating procedures, while expanding access to those life-saving procedures for our patients,” says SafER chief medical officer, Rick Blubaugh, DO, in a release.
The SafER System
The SafER system is a portable negative pressure system that utilizes HEPA filtration to capture dangerous fugitive emissions at the source: the patient. The system has been in use since the pandemic in hospitals, ambulances, and long-term facilities around the country and can be utilized during a variety of procedures including intubation, nebulizer, CPAP or Bi-Level PAP, endoscopy, and sputum or swab collection.
The study is randomized controlled and will take place in a 1,000-bed tertiary facility. It is expected to enroll 80 patients over a three-month period. The goals of the study are to assess the system and the reduction of aerosol emissions produced during bronchoscopic procedures.
Results of the study are expected to be announced late this summer.
Photo caption: SafER negative pressure system
Photo credit: SafER Medical Products LLC
