Potential Adverse Events - COOK Medical Rapi-Fit Gebrauchsanweisung

PRECAUTIONS
• The product is intended for use by clinicians trained and experienced in
airway management techniques. Standard techniques for placement and
exchange of ETTs should be employed.
• This product is not intended for intravascular use.
• Lubricate the catheter and ETT (with a sterile lubricant) before use.
• This device is not recommended for definitive, long-term airway
management.

POTENTIAL ADVERSE EVENTS

• Barotrauma
• Pneumothorax
• Hypoxia
• Perforation of the trachea, bronchi, or lung parenchyma
• Catheter migration
• Failed endotracheal tube placement
INSTRUCTIONS FOR USE
1. Before advancing the Cook Airway Exchange Catheter (CAE) into the ETT
to be replaced, verify correct ETT position.
2. Using the outer margin of the patient's mouth or nasal orifice as a
landmark, note the marking on the ETT. A piece of tape or other marker
may be placed on the CAE at the corresponding distance from the tip to
aid in correct placement within the ETT.
3. Advance the CAE, sideported end first, into the ETT to be replaced.
(Fig. 1) NOTE: It is recommended that a sterile medical-grade lubricant,
approved for use in the airway, according to hospital protocol, be applied
to the orifice of the ETT prior to introduction of the CAE.
4. Properly position the CAE within the ETT by aligning the appropriate
centimeter mark on the CAE with the corresponding centimeter mark
on the ETT. This placement is determined by visualizing the indicated
centimeter length of the ETT, in place, as shown on its surface scale. (For
example, an ETT that has been shortened to 24 cm should have the 24 cm
marker of the CAE catheter aligned at the 24 cm mark of the ETT.)
5. Fully deflate the cuff of the ETT. While maintaining the position of the
CAE, remove the ETT, leaving the CAE in place. (Fig. 2)
6. While maintaining the position of the CAE, use the patient's mouth or
nasal orifice (depending on approach) as a landmark and advance the
new tube over the CAE into appropriate position. (Fig. 3) NOTE: It is
recommended that a sterile lubricant be applied to the tip of the ETT
prior to advancing the ETT.
7. Remove the CAE and inflate the cuff of the new ETT. Verify the new ETT's
position using standard methods (e.g., capnography, breath sounds, and
chest x-ray). Resume ventilation and secure the new ETT in place. (Fig. 4)
Use of Rapi-Fit® Adapter
Rapi-Fit adapters should only be used when oxygen requirements are
high and intubation is unsuccessful. Use of an oxygen source should only
be considered if the patient has sufficient egression of the insufflated gas
volume. If an oxygen source is used for insufflation, begin at a lower pressure
and work up gradually. Observe the chest for outward and inward movements
to confirm oxygen insufflation and egression. Pulse oximetry and oral air flow
should be carefully monitored as well. In cases of upper airway obstruction,
gas discharge from the patient's lungs may require more time.
1. To attach the Rapi-Fit Adapter, position the adapter on the catheter, then
push the white collar forward and lock into position. (Fig. 5)
2. To remove the adapter, pull the white collar back to release, and then
remove from the catheter. (Fig. 6)
Catheter Oxygenation
The Cook Airway Exchange Catheters are designed for both positive airway
pressure ventilation (Rapi-Fit Adapter – 15 mm connector) and jet ventilation
(Rapi-Fit Adapter – Luer lock connector) for both adult and pediatric patients. In
the table below, the delivered minute volume and the measured airway pressure
are given for jet ventilation in adult and pediatric patients with healthy lung tissue.
Real
Part Patient Subgroup and Age
Number Range
(RPN)
Infant
Child
C-CAE-
8.0-45-
01
Adolescent
Adult
Delivered
Minute
Volume
(L/min)
> 1 month
to 2 years
> 2 years to
12 years
> 12 years
through 21
years
> 21 years
5
Measured Airway
Pressure
1
Mean
0.6 8.9
0.1 2.1
0.1 2.2
0.7 3.0
(cm H O)
1
2
Maximum
9.5
2.5
2.6
3.2