https://www.medpagetoday.com/meetingcoverage/isc/70811?
LOS ANGELES -- A novel feeding tube device that electrically stimulates the throat in stroke patients with dysphagia substantially increased readiness to lose the tracheostomy tube, the sham-controlled PHAST-TRAC trial showed.
In the treated group, 49% were ready for removal of their tube, as determined by fiberoptic endoscopic examination of swallowing, after 10 minutes of treatment a day for 3 days compared with 9% in the sham control group (17 versus 3 patients,
(ISC).
For those not ready for decannulation at that point, four responded with repeated open-label treatment for a total of almost 60%. None of the responders needed to be re-intubated.
"[There] is this observation that people are sitting in your ICU and can't get out because they need airway control, but they don't>
Larry Goldstein, MD, of the University of Kentucky in Lexington and chair of an ISC press conference where the results were discussed, cautioned that the data was preliminary and did not include certain key clinical endpoints of interest.
"It would be important to know whether patients began oral nutrition earlier, were able to avoid [percutaneous endoscopic gastrostomy] tube placement, and whether the rate of pneumonia is decreased," he told MedPage Today.
While the 70-patient randomized trial did not include a formal cost analysis, "there's a hint there it might be financially worthwhile" based on a "profound difference in length of stay" -- half of the responders were released by day 17 or 18 days compared with median more like 40 days in nonresponders.
When the results were combined with the "comparable" ones from the pilot study, the odds ratio for readiness for tube removal was 10.49. "You don't see an odds ratio like that every day," Bath said.
The device involves a regular feeding tube with ring electrodes on the outside to stimulate the back of the throat, with the idea that it will stimulate nerves leading to any remaining undamaged area of the brain that controls swallowing and get it to reorganize to become dominant. The device has European approval but the FDA will require a U.S. trial, which is under way (PhEED, set to start enrolling in March in an non-ICU population in rehabilitation wards), Bath said.
If the trial is positive, Goldstein speculated that it could also prove useful for the larger group of stroke patients with dysphagia who are not intubated.
The treatment starts at no current then amps up until the patient expresses it is uncomfortable, then backs down by a quarter and remains at that level for 10 minutes.
"You would expect [response] to be current dependent," Bath said in an interview. However, "the people who responded required reasonably high currents but actually lower currents than the people who didn't respond. One of the predictors of nonresponse was people who had been in the intensive care unit for many weeks or even months ... It's quite possible that the lack of response is because of atrophy [of the swallowing system]. So we believe that if you're going to do this, you're going to want to do it quickly -- once the person is off the ventilator but still dysphagic."
Bath cautioned it was a small trial with sequential design, that the person programming the device was unblinded, and that long-term results could not be examined because all nonresponders were allowed pharyngeal stimulation with the device after the initial study- or sham-treatment.
The PHAST-TRAC trial was supported by Phagenesis.
Bath disclosed relevant relationships with Phagenesis.
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