TABLE 3.
Procedure information for participants undergoing balloon dilation
| Randomized to Balloon Dilation | Control Crossed Over to Balloon Dilation | All Participants Undergoing Balloon Dilation | |
| Procedure Details | N = 30a | N = 23 | N = 53 |
| Procedure location | |||
| Clinic office | 70.0% (21/30) | 73.9% (17/23) | 71.7% (38/53) |
| Ambulatory surgical center | 26.7% (8/30) | 17.4% (4/23) | 22.6% (12/53) |
| Hospital outpatient | 3.3% (1/30) | 8.7% (2/23) | 5.7% (3/53) |
| Anesthesia type | |||
| Local anesthesia only | 70.0% (21/30) | 73.9% (17/23) | 71.7% (38/53) |
| General anesthesia | 30.0% (9/30) | 26.1% (6/23) | 28.3% (15/53) |
| Converted from local to general | 0.0% (0/30) | 0.0% (0/23) | 0.0% (0/53) |
| Eustachian tubes treated | |||
| Bilateral | 66.7% (20/30) | 78.3% (18/23) | 71.7% (38/53) |
| Unilateral | 33.3% (10/30) | 21.7% (5/23) | 28.3% (15/53) |
| Total Eustachian tubes treated | 50 | 41 | 91 |
| Technical success rate (unit = ET) | 100% (50/50) | 100% (41/41) | 100% (91/91) |
| Procedure pain scoreb | 3.4 ± 2.9 (21) | 5.0 ± 2.5 (17) | 4.1 ± 2.8 (38) |
| Total number of inflations (unit = ET) | 1.0 ± 0.2 (50) | 1.0 ± 0.0 (41) | 1.0 ± 0.1 (91) |
| Total inflation time (min) (unit = ET) | 2.1 ± 0.2 (50) | 2.0 ± 0.0 (41) | 2.0 ± 0.2 (91) |
aOne participant randomized to balloon dilation was lost to follow-up before undergoing the balloon dilation procedure.
bPain assessments were evaluated for participants undergoing local anesthesia only. Score of 0 = no pain, 10 = worst pain.
Numbers are mean ± SD (n) or percents (count/N). N is participant unless otherwise specified. ET indicates Eustachian tube.