Relevant Clinical Articles

Safety and performance data from investigation(s) related to TrachFlush “flush” maneuver:

 

The use of a manual deflation and inflation of the endotracheal tube cuff or tracheostomy tube cuff has been used in the clinical practice since 1990s and has in recent literature been used in artificial cough maneuvers and maneuvers for prevention of vocal fold dysfunction, tracheal nerve compression, and mucus membrane compression.

 

According to the recent literature and data, the use of rapid deflation and inflation during mechanical or manual ventilation develops a powerful flow around the deflated cuff expelling secretion from the below and above the cuff in the upper airway.

 

The rationale of this maneuver is to enhance/mimic the patient’s coughing and was prior to TrachFlush - an all-manual intervention.

 

In the study, The Evaluation of the Safety and Effectiveness of the Rapid Flow Expulsion Maneuver to Clear Subglottic Secretions in Vitro and in Vivo, by J. Li, Y. Zong, Q. Zhou, H. Dai, and C. Wang, in Respiratory Care, 2017, Vol 62 No 8, Page 1007-1013, the method of compressing a resuscitation bag while performing a rapid deflation and inflation of an endotracheal cuff was assessed. This paper consists of a study to confirm the safety and effectiveness of performing a rapid deflation and inflation of an endotracheal cuff using a manual device (syringe) while enhancing the flow around the deflated cuff using a resuscitation bag, a maneuver used since the 1990s in Beijing Chaoyang Hospital and referred to as Rapid Flow Expulsion Maneuver (RFEM). The study found the maneuver to be safe and well tolerated by the subjects. In support of the clinical results, an in-vitro study to assess the effects of the maneuver as well as to explore influential factors was performed.

 

In the study, The Evaluation of the Safety and Effectiveness of the Rapid Flow Expulsion Maneuver to Clear Subglottic Secretions In Vitro and In Vivo, by K. Lamb and E. Kriner, in Respiratory Care, 2017, Vol 62 No 8, Page 1111-1112, the safety and effectiveness of the Rapid Flow Expulsion Maneuver (or artificial cough maneuver) to clear subglottic secretions was evaluated. The authors found that, Jie Li et al. with their approach of implementing a rapid flow expulsion maneuver,

potentially add to the clinician’s arsenal of options to remove those subglottic secretions. Of importance, and yet not determined, will be the effectiveness and impact on important clinical outcomes when using the maneuver to clear subglottic secretions. The authors conclude that the

described procedures appear to be safe, effective, and reproducible, thereby translating nicely into the clinical setting

 

In the study, The Rapid-Flow Expulsion Maneuver in Subglottic Secretion Clearance to Prevent Ventilator-Associated Pneumonia: A Randomized Controlled Study, by Y. Li, X. Yuan, B. Sun, H. Li, H. Chu, L. Wang, Y. Zhao, X. Tang, R. Wang, X Li, Z Tong, C. Wang,  in Research Square, 2021, Pages 1-16, the efficacy and safety of the Rapid Flow Expulsion Maneuver (RFEM) in preventing VAP was compared with standard subglottic secretion drainage (SSD). This prospective randomized clinical

trial on 241 patients investigating the RFEM, an artificial cough maneuver, utilizing rapid cuff deflation and inflation of the cuff, found the maneuver to be safe without severe complications. The study found no significant difference in the incidence of VAP between the RFEM and SSD

group and may therefore serve as an alternative method for SSD.

 

In the above 3 studies, the Rapid-Flow Expulsion Maneuver was performed manually. It was a two-person setup, where one person managed the rapid deflation and inflation of an endotracheal cuff using a manual device (syringe) and the other person managed the ventilator or a resuscitation bag, in order to enhance the flow around the deflated cuff. Cumbersome, although effective, but not effective in clinical practice.

 

In the study, An Artificial Cough Maneuver to Remove Secretion from Below the Endotracheal Tube Cuff, by A. Zanella, G. Florio, E. Rezoagli, M. Pastore, P. Cadringer, O. Biancolilli, E. Carlesso, V. Scaravilli, G. Ristagno, and A. Pesenti, in Respiratory Care, 2019, Vol 64 (4), Page 372-383, the TrachFlush technology was evaluated, and it was found that the TrachFlush technology could effectively deflate and inflate the cuff of an endotracheal tube during prolonged inspiratory time and thereby could a flow around the cuff be generated between 1,42-2,14 L/s and aspiration could be prevented. It was also found that this flow may be capable of clearing even the thickest secretions accumulated below the ETT cuff.

 

In the above study, an automated artificial cough maneuver (TrachFlush technology) was evaluated, and it was found that automating the RFEM maneuver (TrachFlush technology) was very effective.

 

Following this, AW Technologies designed and developed the TrachFlush, in order to make it easy to use, and possible to implement in clinical practice

Safety and performance data from investigation(s) related to TrachFlush “Cuff Controller”:

 

According to the recent literature and data, the use of a cuff control device is very usefull in the prevention of Ventilator Associated Pneumonia (VAP)

 

In the study, The Changes of Endotracheal Tube Cuff Pressure during Manual and Intermittent Controlling in Intensive Care Units, by R. Nazari, C. Boyle, M. Panjoo, M. Salehpour-Omran, H. Nia, and A. Yaghoobzadeh, Iranian 20 Journal of Nursing and Midwifery Research, 2020, Vol 25 Issue 1, Page 71-75 it was found that the cuff pressure of the ETT is reduced during manual intermittent control during connection and disconnection of the pilot cuff to the cuff pressure manometer. Therefore, it is suggested to use appropriate measurement tools (continuous cuff pressure regulator) instead of manual intermittent controlling of the cuff pressure

 

In the study, Is continuous better than intermittent control of tracheal cuff pressure? A meta-analysis, by Z. Wen, L. Wei, J. Chen, A. Xie, M. Li, and L. Bian, Nurs Crit Care, 2019, Vol 24 (2), Pages 76-82 it was found that continuous control of cuff pressure offers more benefits in stabilizing the cuff pressure and reducing the incidence of VAP, and more studies are warranted to further evaluate its effect.

 

In the study, Endotracheal tube cuff pressure changes during manual cuff pressure control manoeuvres: An in-vitro 35 assessment, by N. Aeppli, B. Lindauer, M. Steurer, M. Weiss, and A. Dullenkopf, Acta Anaesthesiol Scand., 2019, Vol 63 (1), Pages 55-60 it was found that routine manual cuff pressure control result in considerable cuff pressure drops. This might lead to silent aspiration.

 

In the study, Efficiency of an electronic device in controlling tracheal cuff pressure in critically ill patients: a randomized controlled crossover study, by A. Rouze, J. Jonckheere, F. Zerimech, 5 J. Labreuche, E. Parmentier-Decrucq, B. Voisin, E. Jaillette, P. Maboudou, M. Balduyck, and S. Nseir, Ann Intensive Care., 2016, Vol 6 (1) it was found that the percentage of time spent with underinflation or overinflation was significantly lower during continuous control of cuff

pressure compared with routine care. No significant difference was found in occurrence of microaspiration between the groups. Further studies are needed to determine the impact of continuous cuff control on intubation-related complications.

 

In the study, Continuous control of tracheal cuff pressure and microaspiration af gastric contents in critically ill patients, by S. Nseir, F. Zerimech, C. Fournier, R. Lubret, P. Ramon, A. Durocher, and M. Balduyck, Am J Respir Crit Care Med., 2011, Vol 184 (9), Pages 1041-1047, it was found that continuous control of cuff pressure is associated with significantly decreased microaspiration of gastric contents and reduced the incidence of VAP in critically ill patients. According to the authors, implementation of continuous cuff control should be considered in ICUs with VAP rates.

 

In the study, Continuous endotracheal tube cuff pressure control system protects against ventilator-associated pneumonia, by Leonardo LorenteMaría LecuonaAlejandro JiménezLisset LorenzoIsabel RocaJudith CabreraCelina Llanos, and María L Mora in Crit Care. 2014; 18(2): R77 it was found that the use of a continuous endotracheal cuff pressure control system and/or an endotracheal tube with a lumen for SSD could help to prevent VAP by 50% in patients requiring more than 48 hours of mechanical ventilation.