We were lucky to have worked with Dr. Ciaglia on developing his products. This summer, in 2014, we learned that we shipped the millionth unit of the Ciaglia Blue Rhino. This milestone came as a bit of a surprise to us—for a procedure that was at first very slow to catch on with clinicians.
Dr. Pasquale “Pat” Ciaglia (pronounced chal-ya) became a physician inventor late in his career. However, this late start didn’t stop him from developing several important products to improve patient care. The most notable one was the Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer in 1996, the one you see being made in the video below.
Learn more about Dr. Ciaglia and the Blue Rhino
Click here to see more interesting facts about Dr. Ciaglia and the Blue Rhino
It started by chance
Dr. Ciaglia was concerned with the number of complications patients experienced using a surgical (or open) tracheostomy technique. He knew that there had to be a better way. One day, at St. Elizabeth Medical Center in Utica, NY, Dr. Ciaglia happened to see a colleague performing a percutaneous kidney stone removal procedure with a set of straight serial dilators, the Amplatz Renal Dilator Set. This device used a minimally invasive, over-the-wire, Seldinger technique to access the kidney.
Realizing that the same principle of using sequentially larger dilators could be used for tracheostomy, Dr. Ciaglia wanted a closer look at those renal dilators. As good fortune would have it, the Cook Medical representative for this hospital happened to be supporting the procedure that day.
Dr. Ciaglia worked with Cook to modify the renal dilator set to better accommodate the anatomy of a trachea. The first percutaneous dilatational tracheostomy (PDT) set was launched in 1987 (see image at right). The first Ciaglia Percutaneous Tracheostomy Introducer Set changed an open surgical technique into a minimally invasive one.
The first PDT product was a set of seven serial dilators that incorporated an angled, tapered tip to accommodate the anatomy of a trachea.
Early adopters were few and far between
After he became comfortable with the new tracheostomy dilator set in the operating room, Dr. Ciaglia sought to move this procedure to the bedside in the ICU, which was unheard of at the time.
Early adopters of bedside PDT were few and far between. One of our sales reps recounted being laughed out of physicians’ offices.
People would tell me, ‘That's the stupidest thing I've ever seen.' We got kicked out of offices all the time.
Current global business unit leader for Critical Care, who was a sales representative when PDT launched
Why use seven dilators when you can use one?
It took about a decade of using the seven-dilator set for PDT to catch on, but Dr. Ciaglia was already busy improving the procedure. He thought: Why use seven dilators when you can use one? He found inspiration in the dilators he saw in nature, including tusked animals like walruses and elephants. This realization was the inspiration for a single, graduated dilator that could dilate the tracheal tissue in one pass. The Blue Rhino was born.
The first Blue Rhino was a major feat for the Cook engineers. According to one of the lead engineers, “Producing a long taper was really challenging. We needed a custom mold, but we weren’t even sure if the product would work.”
Dr. Ciaglia’s passion for using PDT to improve patient care assured us that we needed to pursue the graduated dilator.
There's no going back to the way it was.
Dr. Stuart Lowson Director of Critical Care, University of Virginia Health System
From pellets to an ice bath, these are some of the steps involved in manufacturing the Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer.
A new standard of care
Despite the slow early adoption of the procedure, performing PDT with the Blue Rhino at the bedside is now the standard of care in many hospitals around the world. According to Laura Ogilvie, Asia-Pacific sales and marketing manager for Cook’s Critical Care division, “It’s exciting to see how this product and the percutaneous technique went from something that was not feasible to being an established procedure—and the procedure of choice.”
However, there are areas of the world where the adoption of PDT is still in the early stages. Though our friend Dr. Ciaglia is no longer with us, we maintain his passion for this procedure and continue to train clinicians at new locations on the technique.
PDT revolutionized what we were doing before. Now it's the standard of care.
Dr. Demetrios Demetriades, Director of Acute Care Surgery at University of Southern California
Behind Dr. Ciaglia's surgical mask: an inventor, a friend, a husband
Dr. Ciaglia began inventing medical products toward the end his career as a thoracic surgeon. When he began working with Cook on the serial dilator project, he forged strong relationships with the engineers and product development team.
“There was a time when my phone would ring every morning at 8 a.m. and I knew it would be Dr. Ciaglia. Even without Caller ID, I knew it was him. And every morning, he would ask, ‘What are we working on today?'” said Frank Fischer, an engineer at Cook.
“He really believed in the Blue Rhino and would carry one in his pocket just in case somebody asked him about it,” said Bruce Gingles, who worked in the Cook Critical Care division during the development of PDT.
If Cook was exhibiting at a medical meeting, Dr. Ciaglia (center) and his wife would have their own booth to show doctors the PDT procedure.
Dr. Ciaglia’s wife, Jacqueline, was very supportive of the work he did. She would accompany him to medical meetings and help him demonstrate his products and teach physicians his technique.
A shared history
While Dr. Ciaglia was passionate about helping his patients, there was one thing he loved more: his family. Dr. Ciaglia served in France during WWII, and it was there that he met and married Jacqueline. A fellow soldier and physician, Dr. Cesare Gianturco, served as best man at the wedding. Coincidentally, Dr. Gianturco also later developed products with Cook—for embolization, vascular stenting, and the prevention of life-threatening blood clots.
After the war, the two physicians lost touch. Many years later, during a visit to Cook headquarters, Dr. Ciaglia recognized a picture of Dr. Gianturco, which prompted a discussion regarding their unique friendship. It was interesting that neither were aware that the other had been working with Cook. This led to organizing a surprise meeting between the two at a medical meeting nearly 50 years after Dr. Ciaglia and Jacqueline’s wedding.
Dr. Ciaglia and Dr. Gianturco served in WWII together, stood up as best man at each other’s weddings, and also both invented medical devices with Cook.
Passion and compassion
Inside and outside of the hospital, Dr. Ciaglia was known as a man of passion and compassion. Toward the end of his life, he wrote his own “obitulogy” including an excerpt below:
Pat was proud of very few things.
One was the fact that he did not send unpaid patient bills to a Collection Agency.
Neither were the wages of a non-paying patient ever garnished.
Dr. Ciaglia wrote his own “obitulogy.”
As the millionth-plus Blue Rhino travels along the production line, we reflect back on the milestones Dr. Ciaglia achieved. We want to say “thank you” to a man who revolutionized patient care. And then we’ll move forward to help more patients by carrying on the good doctor’s vision.
Grazie, dottore.
Join the conversation on Twitter using #PercTrach.
Interesting facts about Dr. Ciaglia and Blue Rhino
Dr. Ciaglia befriended everyone at Cook.
Mariano Esco, Monika Lochner, and Dr. Ciaglia at a medical meeting in the 1990s.
We held a contest to name the product
Andy Cron, current global leader for the Cook Surgery division, held a naming contest when he was the marketing manager during the Blue Rhino product launch.
The visuals came naturally
Once the name Blue Rhino was selected, the visuals came naturally.
A global impact
The Blue Rhino impacted medicine around the world, particularly in Europe where PDT at the bedside is the standard of care.
A passion for learning
Dinner with Dr. Ciaglia was a true experience filled with lively discussion about his love of the arts and new technology.
Nature’s dilators
Dr. Ciaglia believed that many dilators already existed in nature. This depiction of a rhinoceros with a blue horn is one interpretation.
Innovation can come from anywhere
Dan Sirota, global leader for the Cook Critical Care division, believes that anybody anywhere can be innovative.
See how it’s done
PDT allows physicians to perform tracheostomies at the bedside.
Testing
As the millionth-plus Blue Rhino travels along the production line, we reflect back on the milestones Dr. Ciaglia achieved. We want to say “thank you” to a man who revolutionized patient care. And then we’ll move forward to help more patients by carrying on the good doctor’s vision.
Grazie, dottore.
Join the conversation on Twitter using #PercTrach.