RSI procedure gets low level of oversight in Texas
By Danny Robbins
Fort Worth Star-Telegram
Copyright 2008 Fort Worth Star-Telegram
HUNT COUNTY, Texas — Not long after complaining of shortness of breath at her Quinlan home, Patricia Cannon was in a Hunt County ambulance heading north toward Greenville with a drug dripping into her veins capable of paralyzing every muscle in her body.
The drug, succinylcholine, was administered by a paramedic. The intent was for Cannon, thought to be suffering from a blood clot in the lung, to be immobilized while a breathing tube was placed in her windpipe.
But something happened along the way that prevented the tube from being inserted correctly. The job wasn't done until the ambulance delivered Cannon, 41, to the emergency room at Greenville's Presbyterian Hospital. By then, her condition had worsened considerably.
She was found to have suffered brain damage from an extensive period of insufficient oxygen. She died a week later after her family, told there was no hope, requested that she be removed from life support.
Cannon's death is one of several incidents involving Texas EMS providers that demonstrate the perils of a controversial procedure that can be used without restriction in the state even though it is heavily regulated elsewhere.
An examination by the Star-Telegram found that at least two people in Texas have died and another has become permanently disabled after being deprived of oxygen during the procedure, known as Rapid Sequence Intubation.
The incidents, detailed in court records stemming from lawsuits filed by the patients' families, show the harrowing downside of the procedure, which requires that endotracheal intubation, a difficult skill under any circumstances, be performed in the field on people who can no longer breathe on their own.
And the three incidents may indicate a much wider problem, according to some involved in EMS, because the majority of such cases remain unknown to outsiders, even the families of those affected.
"My gut feeling is that, for every one of these cases, there's probably a handful of others you never hear about," said Henry Wang, an assistant professor of emergency medicine at the University of Pittsburgh who has closely examined intubation by EMS personnel.
The situation also raises larger questions about EMS in Texas, illustrating what some believe is a state system that allows paramedics with minimal training to engage in increasingly invasive procedures.
"The elephant in the room is prehospital personnel have a difficult time managing airways," said Robert Simonson, director of emergency services at Methodist Dallas Medical Center and the medical director for CareFlite and six North Texas ground EMS providers. "And they get into particular problems when they paralyze patients. That is a very unforgiving thing."
A powerful procedure
Debate has been raging nationally for years over Rapid Sequence Intubation, or RSI, as the emergency medical procedure has found its way into use by EMS units.
The procedure calls for EMS personnel to induce paralysis with drugs before intubating patients whose airways otherwise would be difficult to manage because of gagging, clenched teeth, combativeness or other factors.
The most commonly used drug is succinylcholine, a short-acting paralytic that's also used when criminals are put to death by lethal injection.
RSI is considered a particularly valuable tool for air medical services, which typically deal with the most serious cases.
But while it has the potential to save lives, it can also be extremely risky. If the breathing tube is improperly inserted or becomes dislodged, the consequences can be disastrous. And because intubation can often be a challenge for paramedics, the stakes are high.
"I compare [RSI] to an M-16 — extremely powerful in the hands of a master who's well-trained and gets a lot of practice, extremely dangerous in the hands of a beginner," said Wang. "Once you give the drugs, it is the point of no return. You must secure that airway."
The controversy has caused some states to limit the procedure, particularly for ground EMS.
Texas has followed a different path, allowing it to be used indiscriminately, even though it has backfired horribly in the hands of some of the state's providers.
The difference lies in that the states restricting RSI have statewide protocols that impose the same clinical standards on all EMS units, while Texas leaves such decisions to the physicians who serve as EMS medical directors.
Although Texas' approach to EMS, known as delegated practice, has long been considered a necessity because of the state's size and diversity, it may be put to the test by RSI.
"If you have a good medical director, somebody who's actively engaged and involved in EMS, you can kind of push the envelope," said Bryan Bledsoe, a Midlothian emergency physician and the author of several EMS textbooks. "The problem is a lot of these services have someone who just signs the chart."
Standard tools not used
In each of the cases examined by the Star-Telegram, records show that EMS personnel failed to use the rudimentary tools that are standard for checking whether breathing tubes are in the proper place.
And while the cases, all of which were settled out of court, generated thousands of pages of deposition testimony and other material on the public record, they never came to the attention of the Department of State Health Services, the agency that licenses EMS providers and paramedics in Texas.
Particularly compelling were the events surrounding Cannon's death in May 2000, just 11 days after she gave birth to her first child.
A lawsuit filed by Cannon's husband, Gary, against American Medical Response, the EMS provider for Hunt County, painted a troubling picture of a paramedic struggling to perform RSI in a moving ambulance.
Records and deposition testimony revealed that Cannon may have gone without oxygen for as long as 20 minutes and that the paramedic did not verify tube placement with any type of carbon dioxide monitoring device.
No action was taken against the paramedic by his superiors, even though it was the Hunt County EMS medical director himself who ultimately intubated Cannon correctly in the emergency room.
The same type of issues were raised as a result of a lawsuit filed against Air Evac Lifeteam by the children of Lu Allen, a volleyball coach at Graham High School who died in August 2003.
Allen's breathing tube was discovered in her esophagus when she arrived at a Wichita Falls hospital after being transported by helicopter from Graham, where she was struck by a pickup.
She was found to have suffered hypoxia, a lack of oxygen, and spent eight days on life support before her family asked that it be terminated.
Deposition testimony generated by the suit indicated that Allen, 58, received RSI while on the helicopter, which was staffed by both a nurse and a paramedic, yet no carbon dioxide monitoring devices were used.
"I'll say this flat out: There is no excuse for a misplaced tube," said William E. Gandy, an EMS educator in Tucson, Ariz., who is known nationally for his expertise in airway management. "We have the means to verify that a tube is in the right place. There's no excuse for not verifying."
While it is difficult to know how widespread such problems might be, many familiar with EMS issues say the incidents that reach the legal system are likely just the tip of the iceberg.
R. Jack Ayres, an Addison attorney who holds a paramedic's license and has long been involved in EMS at the state and local levels, said he knows of at least 50 cases in which botched intubations caused death or disability.
In some of those situations, the patient's family never suspected anything unusual because it was assumed that the outcome stemmed from the injuries or illness that caused the patient to be treated by EMS.
"The reality is the average family doesn't even know a problem occurred," he said.
Simonson said records he has reviewed at CareFlite show that the air medical service regularly has to "bail out" ground EMS crews that fail to intubate paralyzed patients.
"You sit and you look and you go, 'So we got there and the ground service paralyzed the patient and then couldn't get the patient intubated?'" he said.
Simonson said he has come to believe that RSI "needs to go away" when it comes to ground EMS. To that end, he has removed it from the protocols of all but two of the units under his direction because, he said, only those units had the necessary experience.
Wide leeway in Texas
Texas' EMS philosophy means that any provider can use RSI as long as its medical director gives the OK.
Although the system allows providers to attempt a cutting-edge procedure without dealing with a state bureaucracy, it also means the training for it is in the hands of physicians whose only requirement is that they be licensed to practice medicine in the state.
Ayres said RSI is a prime example of how the state has made medical directors "judge, jury and executioner."
State officials acknowledge that there is a risk in allowing RSI to be used without restriction, but they point out that making it off limits wouldn't be satisfactory either.
"If you do it by rule and prohibit it, then the potential is you decrease the ability for that procedure to save someone's life," said Ed Racht, an Austin emergency physician and chairman of the Governor's EMS and Trauma Advisory Council. "If you don't do that, the risk is you have systems with minimal medical oversight that are hurting people because they're not doing it properly.
"The question is, where's the balance? And, nationally, I don't think we really know where that is right now."
The attitude in Texas contrasts sharply to that in other states, including Pennsylvania, Georgia, Colorado and Kentucky. These states have statewide EMS protocols that prohibit the use of RSI by ground providers or allow its use only under tightly controlled conditions.
"Even in the nice, clean environment of an emergency department, it can be a challenging procedure," said Tim Price, state medical adviser for the Kentucky Board of EMS. "You can't just sort of willy-nilly give this over to [EMS] providers in the state."
Wang said it is "alarming" that Texas has no state regulations regarding RSI.
"If you are going to perform a technique as advanced as this, you should be able to demonstrate that you have the tools, resources and training to optimize its performance," he said. "And you should be able to back it up with clinical data."
Intubation is a standard part of paramedic training in Texas, although some question whether it can be taught and practiced sufficiently well enough to ensure safety with RSI.
Anyone the state licenses as a paramedic or an EMT-intermediate can perform intubations.
Paramedics must complete at least 624 "clock hours" of prescribed course work after first becoming a basic EMT, which requires 140 hours. The EMT-intermediate level can be reached by completing at least 160 hours on top of the initial 140.
Becoming certified at either level also requires passing the National Registry exam, part of which is successfully demonstrating intubation on a manikin.
"You can become a paramedic in Texas with less than 700 contact hours, but it takes between 1,000 and 1,500 [to get a license] to cut hair," said Jay Cloud, an EMS instructor at San Jacinto College in Pasadena. "What's wrong with this picture?"
The bigger problem with intubations, according to many in EMS, is staying proficient, mainly because liability issues have made it increasingly difficult for most paramedics to work in hospital settings.
"Nobody is built like a manikin, and, unfortunately, that's where most of our training comes from," said Robert Knappage, EMS lieutenant in the Dallas suburb of Sachse.
The ability of the Department of State Health Services to monitor RSI and intubations is itself limited in several ways.
The agency's EMS/trauma registry does not collect the one piece of data that could show statistically whether a problem exists: the success or failure of an intubation.
EMS providers can lose their licenses if they do not report violations of the state's Health and Safety Code, but there is nothing spelled out as to what must be reported or when it must be done.
Moreover, there are no full-time investigators to scrutinize those matters that are reported.
The cumulative effect, some say, is a system that encourages providers to keep problems in-house and hides serious issues from public scrutiny.
"Presumably, if the public knew that the medics in Chicken Switch were intubating the esophagus 75 percent of the time, they would then go to their city leaders and raise hell about it," Ayres said. "But they don't have that option because they can't get the information."
DSHS officials realize that there are problems with EMS data collection and reporting regulations and are working to correct them, said Maxie Bishop, the agency's EMS director.
"As far as medical control and things that have happened out there, they don't always get reported to the state, and we know that," he said.
The issue of whether RSI should be practiced by ground EMS was underscored by the Cannon lawsuit, which charged that American Medical Response never retrained the paramedic who attempted to intubate Patricia Cannon even after the company, based in Greenwood Village, Colo., became aware of the facts of the case.
The paramedic, Jeffrey Dektor, stated in a deposition that he made two attempts to intubate Cannon, the second time with the ambulance stopped at a parking lot.
He testified that he believed his first attempt was successful but tried again with a larger tube when he noticed that Cannon's oxygen saturation levels continued to decline. During that attempt, he said, the tube became dislodged.
Asked why he didn't use any form of carbon dioxide monitoring, even though it would have been available on the ambulance, he replied: "I cannot state why I did not."
Twenty minutes passed from the time of Dektor's first attempt until Cannon was successfully intubated at Presbyterian Hospital, records show.
Robert Kowalski, who was the hospital's director of emergency medicine as well as Hunt County EMS medical director at the time, confirmed in his deposition that he was the physician who finally intubated Cannon.
He stated repeatedly during the deposition that the matter did not cause him any concern.
Kowalski, who now lives in Cadillac, Mich., said recently he doesn't remember the case well enough to discuss its details.
"It was not a paramedic we had problems with, I can tell you that, because I know the [paramedics] we had problems with, and he wasn't one of them," he said.
Dektor, who remains with Hunt County EMS and has the title "training coordinator," did not respond to phone messages from the Star-Telegram.
The settlement in the case resulted in a $500,000 payment to Gary Cannon and no admission of liability on the part of American Medical Response or other defendants.
The Allen incident involved EMS personnel attached to the Air Evac base in Wichita Falls. It occurred just four months after the company opened the base, its first in Texas.
Allen was intubated seven minutes before the helicopter landed at the United Regional Health Care center in Wichita Falls, according to records. The tube became dislodged before she was treated in the emergency room, the records indicate.
Both the flight nurse and the paramedic acknowledged in depositions that they did not use carbon dioxide monitoring, even though it was available.
The medical director for Air Evac's Wichita Falls base at the time was S. Addison Beeson, a Tulsa emergency physician. She did not respond to messages from the Star-Telegram.
Policies in area cities
Are paramedics allowed to use Rapid Sequence Intubation? Why or why not?
Fort Worth: A "core" of closely supervised paramedics that handles numerous calls every day makes it feasible for MedStar, the city's ambulance service, according to medical director John Griswell. Additionally, he said, paramedics must go through an intensive course before using paralytic drugs and perform two successful intubations on a manikin before every shift.
Arlington: Short transportation times and the inability to train a large number of paramedics are cited by Cynthia Simmons, the local medical director for the city's ambulance provider, American Medical Response.
Dallas: Paramedics in a large system don't have enough opportunities to sharpen their intubation skills, according to medical director Paul Pepe.