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 2007 Ciaglia Blue Rhino (single dilator set) 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: • 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 • Balloon catheter, loading 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
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