What is so unique and advanced about SIMEX cuff subglottic aspiration system?

The SIMEX cuff S and cuff M are engineered and designed specifically for the automated intermittent aspiration of subglottic secretions where the pressure setting and ON/OFF time settings can be programmed to each individual patient’s condition and needs. It is the only system indicated and cleared by the FDA specifically for this use.

Why should I use SIMEX cuff M or cuff S?

• The cuff M and cuff S are the only subglottic aspiration systems designed and indicated for aspiration of subglottic secretions.
• The cuff M and cuff S are the only suction pumps indicated for use with specially designed endotracheal or tracheal tubes with a separate dorsal suction lumen that opens directly above the ballooned cuff of the tube.
• Predominance of new research indicates that continuous aspiration of subglottic fluids can greatly reduce the incidence of Ventilator Associated Pneumonia (VAP) but that intermittent aspiration is more effective and reduces the risk of damage and injury to the tracheal mucosa. 1,6-7 The benefits of reducing incidence of VAP in acute care settings is known, but long term incidence of VAP or reduction of mortality is not known at this time.
• New clinical experience in Europe has demonstrated the efficacy of automatic intermittent subglottic aspiration with the cuff M and cuff S.11

Why is aspiration of Subglottic Secretion important?

Aspiration of oral and/or gastric secretions is the primary route of bacterial entry into the lungs and is believed to be a primary factor in the development of Ventilator-Associated Pneumonia (VAP). Aspiration of subglottic secretion removes oral and/or gastric secretions from above the endotracheal tube cuff before they can go into the lungs.

What is CASS? (Continuous Aspiration of Subglottic Secretion)

During the years 1992 to 2008, numerous RCTs were performed to demonstrate that through continuous aspiration, clinicians could better manage and control the accumulation of secretion above the ballooned cuffed tube and help prevent or reduce the incident of VAP. However further RCT studies demonstrated that use of CASS can cause serious damage and injury to mucous membrane and is not as effective as intermittent aspiration.

What is IASS? (Intermittent Aspiration of Subglottic Secretions)

Because of serious issues and concerns resulting from the CASS approach, during the years 2002 thru 2014, numerous RCTs were performed comparing IASS and CASS. These RCTs demonstrated that through Intermittent Aspiration, clinicians could better manage and control the accumulation of secretion above the ballooned cuffed tube. This helped prevent or reduce the incident of VAP without potential injuries, including the drying of the mucosa that the CASS system caused.

What is the difference between the CASS and IASS and what are the advantages of one system over the other?

• CASS is operated continuously (nonstop) at a very low pressure of -20 mmHg. It is assumed that this pressure is so low that only small amounts of secretions are removed. As a result, clinicians increase the pressure, at will, to facilitate secretion removal; raising the pressure beyond the -20 mmHg guideline recommendations. This is contraindicated.
• With IASS the aspiration is automated intermittent (ON/OFF) and based on recommended higher pressures of up to -150 mmHg. This allows for increased volumes of drainage as well as long pause times in between suctioning. With the SIMEX cuff S and M, this can be accurately controlled to meet individual patient’s needs.

Are there any RCTs (randomized control trials) conducted to support CASS and IASS?

Since 1992 there have been many RCTs conducted and published in peer reviewed journals to demonstrate the effectiveness of SSD (Subglottic Secretion Drainage). Most recent RCTs clearly demonstrate IASS to be the most effective and advantageous means for SSD and reducing incidents of VAP.

Are there recognized organizations, which recommend the use of SSD?

• American Thoracic Society / Infectious Diseases Society of America (ATS/IDSA) – Level 1
• Centers for Disease Control (CDC) – Category II
• American Association of Critical Care Nurses (AACN)
• Agency for Healthcare Research and Quality (AHRQ)
• Canadian VAP Prevention Guidelines
• Society for Healthcare Epidemiology of America

What are ETT and TT tubes with special dorsal suction lumen?

Since 1992 ETT and TT with special dorsal suction lumens have been introduced to facilitate SSD and to address the growing problem of incidence of VAP in hospitals. Over the years these tubes have been modified and improved dramatically to help provide safe and effective use.

Why hasn’t SSD utilizing new ETT and TT tubes been adopted to its fullest potential by clinicians?

Development of subglottic ETT and TT with special suction ports have dramatically improved the quality and performance of SSD, however this is only part of the solution. There must also be a safe, suitable and complementary aspiration device specifically designed and indicated for use with these ETT and TT tubes. Devices that are currently being used, include wall suction with regulators, syringes and general-purpose suction pumps that are not designed/appropriate nor indicated for subglottic aspiration. Hence, the reason why SSD and the use of more advanced subglottic ETT and TT tubes have not been adopted more fully.

What are the most commonly available devices used in conjunction with ETT and TT tubes to aspirate secretions from subglottic region?

Most currently used devices for aspiration include wall unit with regulator, general purpose powered suction pumps and 5, 10 or 20 ml syringes. These devices are not specifically designed, indicated nor cleared for subglottic aspiration.

What pressure range do manufacturers of subglottic TT and ETT tubes recommend for subglottic aspiration?

• CASS -20 mmHg (-15mbar)
• IASS -80 mmHg to -150 mmHg (-106 to -200 mbar).

If maximum recommended pressure for IASS is -150 mmHg (-200 mbar), what level of a pressure does a simple 5, 10 or 20 ml syringe generate?

Published articles and various bench tests have demonstrated that the maximum pressure generated with the use of syringe increases with the size of the syringe from -671 mmHg (-894 mbar) for a 5 ml syringe to as high as -722 mmHg (-962 mbar) for a 20 ml syringe. These pressures are over four (4) times the recommended pressure guidelines.

We currently use wall suction regulators to monitor pressure. Why do I need the SIMEX cuff M and S devices?

• Wall suction regulators are not indicated for SSD (CASS, IASS)
• Wall suction regulators ON/OFF cycles are too short
• Wall suction regulators negative pressure levels cannot be accurately controlled
• Wall suction regulators are very noisy
• “Are We Suctioning the Life Out of Our Ventilated Patients?” 40 Study results show the mean actual regulator pressure to be significantly higher than the recommended pressure
• “Suction Regulators are Potential Vector for Hospital-Acquired Pathogens” 41

Is there a nationally recognized “standard of care” specifically established for aspiration of subglottic secretion that is followed by most institutions?

Based on data showing what is currently taking place in most institutions, the answer is NO. We believe however, that an issue this serious requires a standard-of-care that can be followed nationally and worldwide

If the most recent RCTs have demonstrated that Intermittent Aspiration (IASS) to be the most ideal system/modality for aspiration of subglottic secretion, why hasn’t it been used and adopted more completely?

Up until today, there have not been any suction devices on the market specifically designed and indicated for Intermittent Subglottic Aspiration. All suction devices currently on the market are for general purpose suction use and not specifically designed nor appropriate for aspiration of secretions from the subglottic space, or for use with subglottic ETT and TT tubes with special dorsal suction lumen.

Are there any aspiration devices on the market specifically designed and indicated for intermittent aspiration of subglottic secretion?

SIMEX cuff S and cuff M are the only subglottic aspiration systems in the market specifically designed and indicated and cleared for automated Intermittent Subglottic Aspiration.

Is SIMEX cuff M and cuff S cleared by FDA?

Yes, and to our knowledge SIMEX subglottic aspiration systems are the only systems approved and indicated for automated intermittent subglottic aspiration of subglottic secretions and to be used in conjunction with specialty subglottic ETT and TT tubes with dorsal suction lumens.

What is the recommend pressure setting for SIMEX cuff S and cuff M?

It is always recommended to start at very low pressure and then build up based on each patient’s need and condition. The factory setting for the SIMEX cuff S and cuff M pump is set at
-100 mbar (-75mmHg).

What is the recommended ON/OFF time setting?

The factory setting for ON/OFF time is 10 seconds aspiration ON time and 10 minutes PAUSE/OFF time. However these time settings can be changed based on each patient’s needs and condition. ON time can be set anywhere between 1-60 seconds and the PAUSE/OFF time can be set anywhere from 1-60 minutes.

Are there ideal pressure and time settings?

This all depends on each patient’s needs and condition. The pressure should be between -100 to -200 mbar (-75 to -150mmHg). The ON/OFF time should be 10 to 15 seconds ON and 10-15 minutes of OFF time.

Are there any contraindications for SIMEX subglottic system?

The SIMEX cuff M and cuff S can not be used for bronchial aspiration.

Are there issues with cross contamination?

The integrated canister design of the cuff M and cuff S pumps minimizes the chances of cross contamination from patient to caregiver and/or patient to patient.

Is device noisy?

Unlike the wall suction regulators or general purpose suction pumps, the SIMEX cuff S and cuff M are virtually silent.

What happens if canister is full?

When the canister of cuff M or cuff S is full, the closed system alarm will sound to indicate that the canister is full and must be replaced. The caretaker must stop the pump, replace the canister and the PVC suction tubing with a new canister and PVC suction tubing (if needed), and make sure the pressure and time settings remain unchanged before re-starting the pump.

Are there clinical experience and evaluations with cuff M and cuff S?

The SIMEX cuff M and S have been in use in Europe since January of 2010 and have been successfully used on over 450 patients in ICU setting and over 50 patients in long term care setting with no complications. In facilities where they have been successfully trialed, they are now being used as the Standard of Care.

What is the daily avg/max amount of secretion aspirated with the use of cuff M and cuff S as compared to conventional systems currently used?

Based on the clinical experience with cuff M and cuff S in both ICU and long term care settings, the volume of secretions aspirated is much higher and up to 10 times the amount aspirated with wall suction or syringe or general purpose suction pumps. This of course is dependent on the patient, and viscosity of the fluid being aspirated. Peak amounts of up to 600 ml of secretion per day have been reported and documented by clinicians both in ICU’s as well as long term care settings.

How does the aspiration of large volumes of secretion impact the frequency of endotracheal/bronchial aspiration?

As more secretion is aspirated from the subglottic region using cuff M or cuff S device, there is less chance of microaspiration of fluid into the lungs and therefore it minimizes the frequency of endotracheal/bronchial aspiration which can be quite excruciating for the patients.

What to do when there is a blockage in the dorsal suction lumen of ETT or TT tube?

Follow the recommendation of ETT and TT manufacturers as stated and instructed in their IFU. Meanwhile the cuff M and S pressure can be increased momentarily to maximum -300 mbar
(-225 mmHg) to help remove the blockage. If this does not resolve the blockage other measures detailed in the IFU of ETT and TT should be considered.

Are most Subglottic ETT and TT tubes compatible with cuff M and S?

Internal SIMEX bench testing with all ETT and TT tubes with special suction lumen on the market, has demonstrated their compatibility and effective aspiration of the fluid accumulated above the ballooned cuff of ETT or TT tube.

Are the SIMEX cuff M and S automatic?

Yes. The pressure and ON/OFF time settings can be selected according to the patient’s needs. The system is then connected to the suction lumen of the ETT or TT tube and the start button will activate the pump. The pump will operate automatically according to the programmed settings until the canister is full and must be replaced.

How do I ensure the settings are locked in and tamper proof?

The SIMEX cuff M and cuff S pumps are equipped with a key lock (automatic locking system). This is automatically activated 15 minutes into the operation and can only be deactivated by the clinician. This is achieved by following the simple instructions in the operating manual.

*Patent Pending