Austin Joseph Winkler is a bright-eyed, mop-headed infant full of smiles. At 2-plus months, he isn't old enough to know that technology being pioneered at LDS Hospital has given him something to really smile about - the opportunity to grow up knowing his mother.
Three things saved Treasure Winkler, 35, when she developed adult respiratory distress syndrome after Austin was delivered by Caesarean section July 12 in a Roseville, Calif., hospital, said her husband, Tony."They were her own will to live, faith in God and the excellent treatment she has received," said Winkler of his wife's "miracle."
"God has spared my life," Treasure Winkler agreed. She greedily watches her husband interact with Austin and looks forward to the day she can leave LDS Hospital and switch from being patient to being mother. "He bonded with Tony first," she said. "Look how he recognizes his voice."
That Treasure Winkler will be returning to her home in El Dorado Hills, a town near Sacramento, can be attributed to advances in treatment of the respiratory distress syndrome, a highly fatal condition in which the lungs swell due to illness or injury. LDS Hospital is conducting a clinical trial to compare the effects of two different treatments for the ailment.
An effective treatment could have potential for saving thousands of lives in the United States each year, said Dr. Alan H. Morris of the hospital's pulmonary division. Morris is director of research in the division and also professor of medicine in the University of Utah School of Medicine.
Even in comparatively mild cases of the syndrome, the survival rate is only about 50 percent, Morris said. "In severe cases, the survival rate is much lower - about 10 percent." In the United States each year, approximately 150,000 patients are diagnosed with the ailment, with 15,000 of these cases in the more serious and highly fatal form.
"There are two organs that cannot tolerate swelling - the brain and the lungs," said Morris.
Treasure Winkler's case was severe. The Roseville hospital quickly exhausted its expertise, and it appeared the disease would take its usual course.
A soccer game led the Winklers to LDS Hospital and the successful treatment of the disease.
"The Roseville doctor's son played soccer with the son of a doctor at University of California-Davis who was aware of the research that was going on at LDS Hospital," said Winkler, who has stayed at his wife's bedside throughout the ordeal - in addition to helping care for Austin.
On July 26, Treasure Winkler was flown by Life Flight from California to Salt Lake City and admitted to LDS Hospital to be evaluated for enrollment in the clinical trial.
The clinical trial has been developed at the hospital to evaluate two different treatments for the syndrome. Patients who meet the criteria of the research project are randomly assigned to either the treatment regimen commonly accepted by today's American pulmonary experts or to a new therapy developed in Milan, Italy, that includes use of a heart-lung machine.
The machine circulates the blood outside the patient's body. It removes carbon dioxide and oxygenates the blood, allowing the lungs to rest, presumably contributing to the healing process.
Although the new procedure has been used in more than 100 patients in Italy and Germany, it has not been evaluated in a controlled, randomized manner. It is too early to make any definitive claims for its success, Morris said.
In the Milan research, a 77 percent survival rate was claimed, "which would put it into the same category as the so-called `miracle drugs,' " Morris said. However, he said, the Italian project was conducted without the definitive research required in America.
At LDS Hospital, 10 patients have been treated, and another one was admitted this week. Two of six treated with the new therapy (one patient with the heart-lung machine) have survived. Three of four of those who received (more conventional) treatment also survived.
In either case, the survival rate exceeds historical expectations of only one surviving patient in 10.
However, Morris said, "The numbers are just too small to arrive at any conclusions. We could lose the next 10 patients _ or save the next 10. We expect that 60 patients will have to enter the randomized clinical trial to allow us to establish a reliable result and make a recommendation to the medical community," he said.
LDS Hospital has an important added component for its research on the syndrome _ the use of a computer to develop consistent treatment protocols and to help doctors make therapy decisions.
The variables that go into medical decisions are many, Morris said, up to and including the physician's training background and the physical and mental condition of caregivers at any given moment. The LDS Hospital clinical trial team spent three years developing detailed treatment plans (protocols) that incorporate the best published logic and the experience of the entire group. These protocols guide the two treatments being compared in the clinical trial. All those involved in patient care abide by them.
Although a physician's discretion can still override any protocol "decision" _ and always will in all likelihood _ the consistency provided by the computerized protocols is invaluable in creating valid research results, he said. "The computer-human combination closes the loop."
There is a detailed protocol for each step of each of the two treatments being compared, as well as a diagnostic protocol common to all treatments. The consistency in the protocols may improve results for those patients who are on standard therapy, as well as those receiving the new therapy that may include use of a heart-lung bypass machine, Morris said.
LDS Hospital has a history of innovation in developing medical applications of computer science. The HELP computer system developed over a 30-year period by Dr. Homer Warner and colleagues created a unique approach that completely integrates all patient information from all sections of the hospital.
Information from admitting offices, pharmacy, labs and patient care areas are integrated and becomes, in essence, the patient's "file folder," Morris said. It also creates a finely detailed record for the researchers. "We are able to minutely describe to colleagues what we did." Sometime in the future, he said, they may test computer-assisted care against a non-computerized protocol to see if they can quantify differences.
Morris and other LDS Hospital physicians visited Milan to discuss the syndrome research with scientists there before approaching the National Heart, Lung and Blood Institute for financial support to develop the clinical trial at the Salt Lake hospital. Approximately $1 million was provided for the three-year project. The grant supports the clinical trial staff, which, at no additional cost to the patient, helps the large LDS Hospital clinical staff that actually provides patient care.
The clinical trial has been slowed by a lack of referred patients, Morris said. He is encouraging other physicians to refer patients to complete the trial. The computerized protocols will be published in a medical journal, as will the clinical trial results when they are available. The Salt Lake group also is communicating with pulmonary specialists in other American cities and at the University of Paris, France, regarding requests to use the protocols.
Another snag lies in convincing health insurance companies to underwrite the costs of care for patients transferred to the special care environment at LDS Hospital for patients with the syndrome.
The Winklers got their insurance company's permission to participate in the clinical trial.
For Treasure Winkler, the most important parts of her treatment took place without her knowledge. She was too ill to be aware of any of the procedures that are required by the uneven course of the syndrome.
"I have no recollection of anything until two weeks ago," she said. She still faces unpleasant procedures and probably two to three weeks more hospitalization _ thoughts that "still make me feel very afraid. I get panicky."
After seeing another patient, however, who is just beginning along the path she has traveled, she said, "It made me feel I really may be doing better. Others think I am looking better, but I don't always see it."
Despite all the rough spots behind and those that lie ahead, Treasure Winkler is grateful and appreciative of the LDS staff that "has personally cared about me. I feel very blessed. I'll be able to raise my son."