Table 2.
Details of treatment cycles and device-related events for all enrolled participants.
| MS ID | Order in study | Days with tube (total #) | Cycles done (total #) | Anchor issues (Y/N) | Tube issues (Y/N) | Wished to continue (Y/N) | Reason for stopping | Device-related issues |
|---|---|---|---|---|---|---|---|---|
| 1 | 3 | 0 | 0 | N | NA | N | Too busy | Minor buccal mucosal irritation. |
| 2 | 9 | 0 | 0 | Y | NA | N | Unable to place anchor | Unable to place anchor comfortably on low-profile molar. |
| 3 | 13 | 0 | 0 | Y | NA | Y | Unable to tolerate anchor | Shallow buccal mucosal ulcer due to mucosa lying on sharp edge of channel on single isolated molar. |
| 4 | 15 | 0 | 0 | NA | NA | Y | End of the study | None |
| 5 | 11 | 0 | 0 | N | Y | N | Anxiety after tube placement and test MM | Discomfort at anchor site in mouth on tube placement. |
| 6 | 2 | 0.5 | 0 | N | Y | N | Gagging on reclining at home first evening | Reported tube riding up into throat possibly due to high intra-abdominal pressure with BMI of 92.5 kg/m2. |
| 7 | 16 | 5 | 0.2 | Y | Y | N | Multiple minor problems, including busy schedule and anxiety after tube placement and test MM. | Discomfort at anchor site in mouth on tube placement, sore throat for 5 days, unable to administer feeds, likely due to kinked tube. |
| 8 | 4 | 7 | 0.25 | Y | N | Y | Unable to tolerate anchor after 7 days. | Shallow buccal mucosal ulcer due to mucosa lying on sharp edge of channel on single isolated molar. |
| 9 | 6 | 14 | 1 | N | N | N | Intercurrent unrelated clinical tests | None |
| 10 | 10 | 14 | 1 | N | N | N | Non-adherent to intervention | None |
| 11 | 8 | 28 | 2 | N | N | Y | Too busy | None |
| 12 | 12 | 42 | 3 | N | N | Y | End of the study | Tube removed by participant on one occasion after gagging while brushing teeth. Replaced next day without incident. |
| 13 | 14 | 42 | 3 | N | N | Y | End of the study | None |
| 14 | 7 | 56 | 4 | N | N | Y | Too busy | Tube removed by study team 1 day early on 1 occasion as precaution. Participant had lower back pain likely due to unrelated urinary tract infection. |
| 15 | 1 | 56 | 4 | N | N | Y | End of the study | Participant repeatedly bit on tube while eating. On one occasion, this caused a small perforation. Thus, tube replaced prophylactically each week. |
| 16 | 5 | 70 | 5 | Y | Y | Y | Too busy | Channel developed calculus between two cycles requiring reaming out by dentist. Participant felt nauseous twice after strong cooking smells, leading to tube recoil and removal by the participant. |
| Avg (SD) for all enrollees | 20.9 (24.4) | 1.5 (1.8) | Y: 5 | Y:4 | ||||
| N:10 | N:8 | Y:9 | ||||||
| Avg (SD) for 10 enrollees with tube > 1 day | 33.4 (23.1) | 2.4 (1.7) | NA:1 | NA:4 | N:7 | |||
| Total | 334 | 23.8 | ||||||