The Egret Extended Term™ Closed Suction System is intended to maintain a patient’s airway by aspirating excess fluids, secretions and exudates through the artificial airway. The device allows for saline lavage to the distal airway, and the sizes designated for neonatal use also provide a port for surfactant delivery. The closed system device allows for multiple suction episodes using the same catheter. The protective sleeve of the closed system isolates the flora from the patient’s secretions.
Egret Medical Products Inc.
Extended Term™ Closed Suction System
The device is indicated for patients with indwelling oral or nasal endotracheal tubes, and tracheostomy tubes, and who may require a range of airway and respiratory support. They may be spontaneously breathing, on mechanical ventilation, or partially supported by mechanical devices. The Egret Extended Term™ Closed Suction System is designed for single patient use and is to be used up until soiled or per hospital procedure.
A significant number of RCP’s rated the Egret catheter as an improvement compared to the Ballard catheter in the following five categories: suction valve ease of use; valve locking safety feature; catheter positioning and ease of manipulating; product flexibility to patient movement; comfort to patient.
COMPARATIVE STUDY
The Egret and Ballard catheters were both Adult 14 Fr. models. The Egret catheters were used continuously for up to 10 days as the condition of the patient warranted. The Ballard catheters were changed out daily per the supplier’s recommendation and current Medical City Hospital policy1. Immediately after patient use, the catheters bagged and transported to MicroChem Laboratory and were assayed for aerobic bioburden in a similar manner as had been done for the baseline study.
The Egret catheters were tested for bioburden levels after 1, 3, 5, 8, and 10 days of continuous use. The Protocol called for 20 Egret catheters to be tested at each of the 5 time periods. However, 21 Egret catheters were actually tested after 1 day of use, and 19 Egret catheters were tested after 8 days of use. Twenty Egret catheters were tested at each of the other time periods.
Twenty Ballard catheters were tested after 1 day of use at each of the 5 Egret catheter sampling points. The 20 Ballard catheters that were in use on day 1 of Egret catheter use were tested immediately following that single day of use. The 20 Ballard catheters that were in use on day 3 of Egret catheter use were tested immediately following that single day of use. The 20 Ballard catheters that were in use on day 5 of Egret catheter use were tested immediately following that
single day of use. And similarly for days 8 and 10 of Egret catheter use.
Table 1. Egret Adult 14 Fr. T-Piece Catheter.
| Study Group | # of days used | # of patients assigned | # of Catheters used |
|---|---|---|---|
| 1 | 1 | 21 | 21 |
| 2 | 3 | 20 | 20 |
| 3 | 5 | 20 | 20 |
| 4 | 8 | 19 | 19 |
| 5 | 10 | 20 | 20 |
| Total | 100 | 100 |
Table 2. Ballard Adult 24 Fr. Elbow Catheter.
| Study Group | # of days used | # of patients assigned | # of Catheters used |
|---|---|---|---|
| 1 | 1 | 20 | 20 |
| 2 | 1 | 20 | 60 |
| 3 | 1 | 20 | 100 |
| 4 | 1 | 20 | 160 |
| 5 | 1 | 20 | 200 |
| Total | 100 | 540 |
As per Protocol RT 2008-001, clinicians who participated with Egret’s clinical trial were asked to complete a questionnaire (see attached). In total, 90 questionnaires were completed and returned to the sponsor.
Egret’s clinical trial results
| Not Acceptable | Same as Current | Improved | |
|---|---|---|---|
| Use of Change-Out Label | 62 | 28 | |
| Connection to Suction Tube | 62 | 28 | |
| Suction Valve – Ease of Use | 6 | 84 | |
| Gage and Feel of Sheath Material | 48 | 42 | |
| Valve Locking Safety Feature | 3 | 87 | |
| Ease of Connection to the Trach or ET Tube | 53 | 37 | |
| Catheter Positioning and Ease of Manipulation | 18 | 72 | |
| Communication\Visibility of Depth Markings | 72 | 18 | |
| Use of Saline Ports | 71 | 19 | |
| Tip Cleaning Process and Result | 65 | 25 | |
| Product Flexibility to Patient Movement | 14 | 76 | |
| Affect of Heat on Product Function | 73 | 17 | |
| Perceived Weight of Product | 36 | 54 | |
| Comfort to Patient | 13 | 77 | |
| Did Sheath Remain Dry During Use? | 67 | 23 | |
| Did End Cap Remain Secure? | 79 | 11 | |
| Ease of Use After Disconnect | 40 | 50 |
Key Benefits & Features of the Extended Term™ Closed Suction System:
- Clinical Proven to reduce bio-burden levels
- Green – Less inventory, less waste, contains no solvents
- Safety – The suction valve is easier to operate than conventional valves. A safety key clearly communicates whether the valve is open or locked.
- Ease of Use – Product is designed to facilitate usage by the care giver. The swivel design allows the product to move easily with interfaces.
- Protection to Caregiver – A micro porous filter prevents bacteria from escaping the device. This feature provides for a true closed system.
- Tip Cleaning – Tip can be easily cleaned from all angles – Just rotate it!
- Extended Use – Extended use results in less exposure to environmental contamination for your patient
- Ease of Selection – Egret’s products are designed to meet an array of usages and needs
- MRI Safe – Egret’s products contain no metals in their valves