SWALLOW SAFETY, TIMINGS AND CLEARANCE: DO MULTIPLE MEASURES DETECT TREATMENT EFFECTS? ANALYSIS FROM THE SWALLOWING TREATMENT OF ELECTRICAL PHARYNGEAL STIMULATION (STEPS) TRIAL. (ID 1372)
Abstract
Background And Aims
We investigated pharyngeal electrical stimulation (PES), a potential treatment for post-stroke dysphagia, using videofluoroscopy swallow studies (VFSS) from the STEPS trial incorporating multiple measures of safety (penetration aspiration scale-PAS), speed and duration (timing) and efficiency (clearance).
Methods
VFSS from randomised participants (baseline and two weeks), frame rate >25fps with 6 x 5ml and 1 x 50ml thin fluid boli were assessed (PES n=43 v sham n=38). Based on PAS scores, the mode, worst and best bolus (5ml) and worst bolus (50ml) was chosen for analysis. Eight timing measures were performed, including stage transition duration (STD) and pharyngeal transit time (PTT). Clearance measures comprised oral and pharyngeal residue (Modified Barium Impairment Swallowing Profile) and number of swallows to clear. Comparisons of change of scoring outcomes between PES and sham were evaluated at 2 weeks.
Results
Between-group analysis showed no statistically significant differences for any measures. Sub-optimal image quality and frame rate acquisition affected final numbers. Table 1 shows selected results for 5ml mode bolus.
| N | PES mean (SD) | N | No PES mean (SD) | Difference (95% CI) | P Value | |
|---|---|---|---|---|---|---|
| PAS | 38 | -1.45 (3.06) | 33 | -0.85 (2.54) | -0.60 (-1.93, 0.73) | 0.37 |
| STD | 28 | -1.98 (8.94) | 27 | -1.05 (3.39) | -0.92 (-4.60, 2.76) | 0.62 |
| PTT | 15 | -3.66 (12.12) | 10 | -1.49 (5.26) | -2.17 (-9.55, 5.21) | 0.55 |
| Swallows to clear | 38 | 0.11 (1.39) | 33 | 0.12 (1.22) | -0.02 (-0.63, 0.60) | 0.96 |
| Pharyngeal residue | 31 | 0 [0] | 29 | 0 [1] | 0 (-1,0) | 0.53 |
Conclusions
Timing and clearance measures did not detect ‘missed’ improvements in swallowing function that PAS was unable to capture
Trial Registration Number
ISRCTN25681641
