Presenting:

Ciaglia Blue Dolphin™

Balloon Percutaneous Tracheostomy Introducer
 Percutaneous Tracheostomy
& Cook Critical Care
June 1985 The technique of Percutaneous
Dilatational Tracheostomy (PDT) first
reported by Dr. Pasquale Ciaglia
1990 Ciaglia Percutaneous
Tracheostomy Introducer Set
(sequential dilator set)
1999 Ciaglia Blue Rhino (single dilator set)
2007 Ciaglia Blue Dolphin Balloon
Percutaneous Tracheostomy
Introducer (balloon dilatation)

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 Development of Percutaneous
Tracheostomy
• August 1997
Patent filed by Dr. Ciaglia on balloon dilatation for
creation of tracheal stoma.

• November 2004
Dr. Michael Zgoda (University of Kentucky Medical
Center, USA) approached Cook with his idea for
further developing the technique of percutaneous
tracheostomy.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 Ciaglia Blue Dolphin Balloon
Percutaneous Tracheostomy Set

2007 – Ciaglia Blue Dolphin Balloon

Percutaneous Tracheostomy Introducer.

A one-step device combining Dr. Ciaglia’s

vision of balloon radial-dilatation and the
method devised by Dr. Zgoda.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 The Evolution of Percutaneous
Tracheostomy

Dr. Zgoda’s aims:

• To simplify the technique of percutaneous
tracheostomy
• To create a device which was intuitive to use
• To create a device which required the minimum
steps possible from incision to ventilation
By achieving these goals, overall procedure time and
the potential for complications may also be reduced.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 The Evolution of Percutaneous
Tracheostomy

The Ciaglia Blue Dolphin embodies the

evolution of the technique of percutaneous
tracheostomy.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

The Advantages
The Blue Dolphin is the
first device to facilitate
creation of the tracheal
stoma and tracheostomy
tube insertion in one step.

The efficient transition

from dilatation to tube
insertion minimizes
airway leak while
optimizing patient
ventilation.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

The Advantages

The Blue Dolphin balloon is firm

and durable enough to dilate
the tough tracheal tissues.

The balloon delivers even and

controlled radial dilatation
which greatly reduces the
downward force typically
needed to create a tracheal
stoma.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 Balloon Dilatation

• The balloon is 5.4 cm long and has

an outer diameter of 16 mm when
fully inflated.
• The maximum inflation pressure of
the balloon is 11 atmospheres (atm).
• The balloon reaches the full 16 mm
outer diameter at 3 atm.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 The Procedure
The Blue Dolphin set includes:
• Balloon catheter, loading • Large fenestrated drape
dilator assembly • Needle cup holder
• Cook Inflation Device 0.035" • Gauze pads
Amplatz wire guide
• 6 cc disposable syringe
• 1 x 18 g introducer needle • Measuring tape
• 1 x 18 g PTFE sheath • Disposable scalpel
introducer needle
• Lubricating jelly
• 14 French, 6.5 cm dilator
• Optional: tracheostomy
tube

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

Preparation
• Patient preparation should be
identical to percutaneous
tracheostomy procedure.
• Prepare and prime Cook Inflation
Device (CID) with 20 ml of sterile
saline
 Note: Do not pre-inflate the Blue
Dolphin balloon – this will disrupt
the low profile of the balloon prior
to insertion.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 The Procedure

• Perform a 2 cm incision over the intended site

of tracheostomy tube placement.
 Ideally between first and second or second and
third tracheal cartilages
• Skin incision must be 2 cm to allow the Blue
Ciaglia Dolphin balloon to fully inflate and
subsequently advance into the trachea.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

The Procedure
Blunt Dissection
• If desired, use a curved mosquito clamp to
gently dissect vertically and transversely
down to the anterior tracheal wall.

• With a fingertip, dissect the front of the

trachea, in the midline, free of any tissue and
identify the cricoid cartilage. Displace the
isthmus of the thyroid downward, if present.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

The Procedure

Withdrawal of the endotracheal tube under

direct vision to a safe area just below the
vocal cords is required.

Bronchoscopic guidance is recommended

throughout the described procedure.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 The Procedure
Percutaneous entry
• Following the Seldinger
technique of entry using a
needle and wire guide, initially
dilate the pre-tracheal tissue
using the supplied 14 Fr dilator.
• Remove the dilator while
maintaining the wire guide in
position.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 The Procedure
Inflate
Pre-load a tracheostomy
tube onto the lubricated
Blue Dolphin balloon
catheter.
 Be sure to align taper of
loading obturator with taper
of trach tube as shown.


Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers
 The Procedure
Inflate
Attach the prepared Cook
Inflation Device (CID) to
the port marked
BALLOON on the balloon
catheter assembly.
 Do not connect to port
marked WIRE.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 The Procedure
Inflate
• With the balloon fully
deflated advance the
balloon catheter
tracheostomy tube
assembly over the wire
guide as a unit.
• Use distal and proximal
markers on wire guide
for correct alignment.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 The Procedure
Inflate
With the balloon still deflated
advance the balloon catheter
tracheostomy tube assembly
with the wire guide until the
balloon is halfway into the
trachea.
 The black mark on the
balloon catheter
indicates the midpoint
of the balloon.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 The Procedure
Dilate
• Disengage the lock
lever on the CID and
inflate the balloon firmly.
• Engage the lock lever
on the CID to maintain
pressure.
• Rotate the palm grip on
the CID until the desired
pressure is reached.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 The Procedure
Dilate
• To minimize chance
of balloon rupture, do
not exceed 11 atm.
• Maintain maximum
inflation pressure for
5-10 seconds.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 The Procedure
Deflate
• Disengage the lock
lever on the CID.
• Immediately deflate the
balloon until all infused
saline is withdrawn.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 The Procedure
Ventilate
• Advance the following as one
unit into the trachea
 Deflated balloon catheter
 Loading dilator
 Tracheostomy tube
 Wire guide assembly
• Direct assembly
perpendicular to tracheal
wall until tracheostomy tube
is within the tracheal lumen.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 The Procedure
Ventilate
• Once the tracheostomy tube
is within the tracheal lumen
the assembly may be
directed caudad.
• Advance the tracheostomy
tube to its flange.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 The Procedure
Ventilate
• Slowly remove the balloon
catheter-loading dilator-wire
guide assembly.
• Inflate the cuff and
connect the tracheostomy
tube to the ventilator.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

 Technique Highlights

• Do not pre-inflate the Blue Dolphin balloon – this will

disrupt the low profile of the balloon prior to insertion.
• Perform a 2 cm skin incision and blunt dissection – this is
necessary to allow full balloon inflation.
• To minimize chances of balloon rupture, DO NOT exceed
11 atm pressure during balloon inflation.
• Maintain maximum inflation pressure for 5-10 seconds.
• Ensure all saline is removed from balloon before
removal through tracheostomy tube.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

Points To Remember

• The Ciaglia Blue Dolphin is intended for controlled,

elective subcricoid insertion of a tracheostomy tube.
• Bronchoscopic guidance is recommended
throughout the procedure.
• Absolute contraindications include:
 Emergency tracheostomy tube placement
 Pediatric applications
 Patients with enlarged thyroids
 Non-palpable cricoid cartilage

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers

Conclusion

The research and development of the Ciaglia

Blue Dolphin Balloon Percutaneous
Tracheostomy Introducer has focused on
creating a one-step device, which is simple to
use and retains the safety with which the Cook
brand is synonymous.

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducers