1. What is the decision or change (e.g. clinical topic, practice guideline, system design, delivery of care) you are facing or struggling with where a summary of the evidence would be helpful?
In spite of more than 20 RCTs and Meta-Analysis studies published since 1992 validating Subglottic Secretion Drainage (SSD) as the most effective method for VAP prevention, it has not been adopted to the detriment of ventilated patients, because of the lack of appropriate, effective, safe, and easy to use suctioning modalities. (see ref 1,2)
The focus of SSD has always been on the subglottic Endotracheal and Tracheostomy tubes and not on the suctioning method used, the frequency of the suctioning, and most important the volume of secretions removed on a daily basis.
A lack of evidence and knowledge gap exists as a result. The challenge is establishing valid and reliable data that can be shared with clinicians in appropriate care settings so that the SSD system can become recognized and accepted and simple to use as a standard of care. Ultimately, this serves to benefit patients in that VAP could be prevented in many cases.
2. Why are you struggling with this issue?
Our data shows that the use of SSD with a proper suctioning device (i.e. SIMEX) versus the current methods (i.e. syringe or wall suction) consistently achieves superior outcomes in removing large volumes of secretions from the subglottic space resulting in better outcomes in terms of reduced VAP rate, time on a ventilator, ICU days and reduced usage of antibiotics. This will also result in the total cost-effectiveness of the system. (see ref 1,3)
Current modalities include syringe, or either Continuous or Intermittent wall suction. Neither of which are effective, safe or indicated for SSD and are potentially harmful to the patients. The SIMEX is the only FDA-cleared system for this indication. Use of syringe or wall suctions are considered OFF-label. (see ref 4-7)
Most clinicians are not aware of this information and the struggle exists in how to educate and fill the knowledge gap. Typically, scientific research that is designed in a reliable way helps support claims and aids in marketing a product to healthcare professionals. Our goal is to implement such research to demonstrate the differences in the current standard of care and how the SSD system can improve outcomes for critically ill patients. ( See ref 8)
3. What do you want to see changed? How will you know that your issue is improving or has been addressed?
We would like SSD to be the standard of care in all ICUs and LTACH facilities for patients on prolonged ventilation and used in concert with a proper suctioning modality.
As mentioned previously, conducting scientific clinical research in a reliable manner can establish outcomes that are valid and accepted in the clinical community. Conducting a randomized, controlled trial comparing current standard of care to the proposed method utilizing the SSD system should demonstrate that VAP rates can be reduced, overall outcomes can be improved, and even cost-effectiveness can be impacted.
4. When do you need the evidence report?
Sat, 07/15/2023
5. What will you do with the evidence report?
Initially, study outcomes will be analyzed and reported to appropriate audiences via medical conferences and congresses. Once this has been done, publication of the study results in appropriate medical journals will be done. This will present the evidence needed to speak to clinicians at their level and offer solid, statistically significant proof that the SSD system can be adopted as a new standard of care.
This will make it easier to set up product evaluations based on evidence from a randomized, controlled trial as the rationale. This literature would also be shared with distributors, sales representatives, and clinical specialists to help create product champions and support a change in the standard of care.
As the number of experienced clinicians grows, we would encourage them to publish and present their experiences at appropriate conferences and congresses.
Supporting Documentation
FloSure Reference Documention for AHRQ New Topic Submission June 15, 2022 (PDF, 14 MB)
Optional Information About You
What is your role or perspective? Administrator
If you are you making a suggestion on behalf of an organization, please state the name of the organization Joseph M. Still Research Foundation, Inc.
May we contact you if we have questions about your nomination? Yes
