Background
Methods
Results
Average force for 2 cm displacement (N) | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
SolidAIRity® | Thomas™ | Anchor Fast | Tape & Mallinckrodt | Twill & Mallinckrodt | Tape & Securisyn tube | Twill & Securisyn tube | ||||||||
Test point | Mean | Standard deviation | Mean | Standard deviation | Mean | Standard deviation | Mean | Standard deviation | Mean | Standard deviation | Mean | Standard deviation | Mean | Standard deviation |
1
| 209 | 0.00 | 31 | 7.70 | 96 | 6.79 | 85 | 26.69 | 50 | 13.59 | 107 | 23.11 | 50 | 6.79 |
2
| 175 | 12.84 | 58 | 26.69 | 83 | 2.57 | 61 | 20.55 | 47 | 2.57 | 82 | 11.19 | 73 | 2.57 |
3
| 90 | 6.79 | 55 | 5.14 | 46 | 2.57 | 82 | 9.26 | 50 | 10.27 | 79 | 28.25 | 62 | 8.90 |
4
| 172 | 13.59 | 65 | 5.14 | 71 | 4.45 | 96 | 11.19 | 55 | 15.62 | 93 | 4.45 | 61 | 5.14 |
5
| 74 | 18.52 | 82 | 2.57 | 65 | 2.57 | 67 | 0.00 | 50 | 6.79 | 68 | 2.57 | 83 | 2.57 |
6
| 193 | 2.57 | 68 | 11.19 | 86 | 6.79 | 98 | 19.39 | 40 | 0.00 | 108 | 28.94 | 79 | 2.57 |
7
| 162 | 13.59 | 85 | 7.70 | 70 | 6.79 | 82 | 20.06 | 44 | 0.00 | 79 | 13.59 | 99 | 13.59 |
8
| 200 | 30.82 | 98 | 7.70 | 92 | 5.14 | 132 | 5.14 | 50 | 5.14 | 96 | 16.84 | 55 | 6.79 |
9
| 113 | 22.83 | 58 | 7.70 | 67 | 4.45 | 67 | 27.06 | 40 | 7.70 | 89 | 20.38 | 80 | 4.45 |
10
| 156 | 4.45 | 68 | 2.57 | 59 | 2.57 | 65* | 13.59 | 39 | 2.57 | 61* | 18.52 | 52 | 6.79 |
11
| 225 | 9.26 | 53 | 4.45 | 73 | 2.57 | 83* | 29.62 | 65 | 2.57 | 102* | 31.14 | 64 | 6.79 |
12
| 224 | 2.57 | 85 | 20.38 | 89 | 4.45 | 77* | 14.30 | 49 | 23.11 | 92* | 21.02 | 59 | 5.14 |
13
| 148 | 5.14 | 71 | 4.45 | 62 | 8.90 | 64* | 11.19 | 36 | 0.00 | 65 | 9.26 | 64 | 5.14 |
Average
|
165
|
11.00
|
67
|
8.72
|
74
|
4.66
|
81
|
16.00
|
47
|
6.92
|
84
|
16.73
|
68
|
5.94
|
Average force for 5 cm displacement or failure (N)
| ||||||||||||||
1
| 215 | 6.79 | 82 | 12.84 | 147 | 15.41 | 144 | 21.02 | 129 | 24.77 | 138 | 27.06 | 145 | 40.36 |
2
| 203 | 26.81 | 83 | 18.52 | 130 | 6.79 | 95 | 2.57 | 104 | 31.56 | 120 | 33.58 | 245 | 11.77 |
3
| 233 | 16.84 | 96 | 11.19 | 129 | 0.00 | 136 | 5.14 | 99 | 12.84 | 179 | 16.84 | 197 | 28.94 |
4
| 234 | 13.59 | 113 | 11.19 | 153 | 24.50 | 175 | 24.50 | 120 | 22.24 | 175 | 6.79 | 202 | 21.94 |
5
| 234 | 20.06 | 129 | 8.90 | 178 | 35.31 | 163 | 21.02 | 87 | 12.84 | 154 | 33.97 | 199 | 35.95 |
6
| 212 | 13.59 | 101 | 9.26 | 86 | 43.66 | 128 | 5.14 | 87 | 14.30 | 142 | 42.90 | 190 | 24.50 |
7
| 218 | 11.77 | 133 | 4.45 | 190 | 25.68 | 162 | 6.79 | 107 | 19.39 | 193 | 31.56 | 227 | 29.17 |
8
| 228 | 21.02 | 130 | 5.14 | 165 | 29.17 | 157 | 2.57 | 130 | 28.94 | 194 | 32.18 | 176 | 56.50 |
9
| 231 | 8.90 | 99 | 9.26 | 130 | 6.79 | 87 | 22.39 | 85 | 30.82 | 128 | 26.06 | 254 | 32.08 |
10
| 251 | 15.62 | 99 | 26.06 | 123 | 11.19 | 65 | 13.59 | 133 | 4.45 | 61 | 18.52 | 205 | 4.45 |
11
| 283 | 12.84 | 93 | 16.04 | 99 | 30.28 | 83 | 29.62 | 126 | 10.27 | 102 | 31.14 | 258 | 31.14 |
12
| 289 | 4.45 | 136 | 20.06 | 98 | 11.77 | 77 | 14.30 | 86 | 9.26 | 92 | 21.02 | 135 | 13.59 |
13
| 273 | 17.98 | 135 | 25.29 | 83 | 5.14 | 64 | 11.19 | 90 | 12.84 | 122 | 17.98 | 128 | 20.06 |
Average
|
239
|
14.64
|
110
|
13.71
|
132
|
18.90
|
118
|
13.83
|
107
|
18.04
|
138
|
26.12
|
197
|
26.96
|
Comparison of force values at 2 cm displacement (N) | ||||||||
---|---|---|---|---|---|---|---|---|
SolidAIRity® | Thomas™ | Anchor Fast | Tape & Malllinckrodt | Twill & Mallinckrodt | Tape & Securisyn | Twill & Securisyn | ||
SolidAIRity®
|
0.000
|
0.000
|
0.000
|
0.000
|
0.000
|
0.000
|
P values
| |
Thomas™
| 97 [61.99; 126.68] | 0.320 | 0.057 |
0.001
|
0.009
| 0.957 | ||
Anchor Fast
| 91 [55.90; 120.00] | -6 [-19.37; 6.60] | 0.188 |
0.000
|
0.052
| 0.296 | ||
Tape & Malllinckrodt
| 83 [42.52; 110.28] | -14 [-36.48; 0.62] | -8 [-29.49; 6.40] |
0.001
| 0.887 |
0.053
| ||
Twill & Mallinckrodt
| 117 [82.75; 145.84] | 20 [8.83; 31.10] | 26 [16.70; 36.02] | 34 [20.90; 54.88] |
0.000
|
0.000
| ||
Tape & Securisyn
| 78 [42.84; 107.46] | -19 [-33.13; -5.24] | -12 [-25.74; 0.15] | -5 [-19.76; 17.25] | -39 [-50.31; -27.98] |
0.006
| ||
Twill & Securisyn
| 97 [61.99; 126.00] | 0 [-13.18; 12.50] | 6 [-5.63; 17.72] | 14 [-0.27; 35.45] | -20 [-29.75; -10.86] | 18 [6.04; 31.64] | ||
Difference between means and 95% confidence interval
| ||||||||
Difference in standard deviation of means at 2 cm displacement
| ||||||||
SolidAIRity®
|
Thomas™
|
Anchor Fast
|
Tape & Malllinckrodt
|
Twill & Mallinckrodt
|
Tape & Securisyn
|
Twill & Securisyn
| ||
SolidAIRity®
| 0.481 |
0.027
| 0.166 | 0.211 | 0.124 | 0.074 |
P values
| |
Thomas™
| 2.27 [-4.30; 8.85] | 0.068 |
0.030
| 0.522 |
0.022
| 0.212 | ||
Anchor Fast
| 6.33 [0.822; 11.85] | 4.06 [-0.35; 8.47] |
0.001
| 0.288 |
0.001
| 0.223 | ||
Tape & Malllinckrodt
| -5.00 [-12.23; 2.22] | -7.28 [-13.81; -0.75] | -11.3 [-16.79; -5.89] |
0.008
| 0.840 |
0.002
| ||
Twill & Mallinckrodt
| 4.08 [-2.48; 10.64] | 1.8 [-3.93; 7.54] | -2.26 [-6.64; 2;12] | 9.08 [2.56; 15.60] |
0.006
| 0.652 | ||
Tape & Securisyn
| -6.64 [-13.16; 1.69] | -8.91 [-14.76; -1.26] | -12.97 [-17.81; -6.33] | -1.63 [-8.11; 6.65] | -10.72 [-16.55; -3.08] |
0.001
| ||
Twill & Securisyn
| 5.06 [-0.55; 10.66] | 2.8 [-1.75; 7.32] | -1.28 [-3.40; 0.84] | 10.06 [4.51; 15.61] | 0.98 [-3.53; 5.48] | 11.7 [4.96; 16.62] | ||
Difference between means and 95% confidence interval
|
Comparison of force values at 5 cm displacement or failure (N) | ||||||||
---|---|---|---|---|---|---|---|---|
SolidAIRity® | Thomas™ | Anchor Fast | Tape & Malllinckrodt | Twill & Mallinckrodt | Tape & Securisyn | Twill & Securisyn | ||
SolidAIRity®
|
0.000
|
0.000
|
0.000
|
0.000
|
0.000
|
0.007
|
P values
| |
Thomas™
| 129 [109.13; 148.41] | 0.065 | 0.530 | 0.651 | 0.036 |
0.000
| ||
Anchor Fast
| 107 [82.07; 132.35] | -22 [-44.59; 1.47] | 0.371 |
0.032
| 0.645 |
0.000
| ||
Tape & Malllinckrodt
| 121 [92.35; 149.00] | -8 [-34.66; 18.46] | 13 [-17.01; 43.93] | 0.365 | 0.214 |
0.000
| ||
Twill & Mallinckrodt
| 132 [113.09; 151.53] | 4 [-12.39; 19.46] | 25 [2.40; 47.49] | 12 [-14.66; 37.92] |
0.019
|
0.000
| ||
Tape & Securisyn
| 100 [72.22; 128.52] | -28 [-54.78; -2.02] | -7 [-37.17; 23.48] | -20 [-53.13; 12.53] | -32 [-58.04; -5.83] |
0.002
| ||
Twill & Securisyn
| 42 [12.60; 71.35] | -87 [-114.51; -59.08] | -65 [-96.67; -33.81] | -79 [-112.52; -44.87] | -90 [-117.79; -62.88] | -58 [-92.10; -24.70] | ||
Difference between means and 95% confidence interval
| ||||||||
Difference in standard deviation of means at 5 cm displacement or failure
| ||||||||
SolidAIRity ®
|
Thomas™
|
Anchor Fast
|
Tape & Malllinckrodt
|
Twill & Mallinckrodt
|
Tape & Securisyn
|
Twill & Securisyn
| ||
SolidAIRity ®
| 0.723 | 0.311 | 0.795 | 0.267 |
0.002
|
0.008
|
P values
| |
Thomas™
| 0.93 [-4.40; 6.26] | 0.232 | 0.969 | 0.181 |
0.001
|
0.006
| ||
Anchor Fast
| -4.26 [-12.90; 4.36] | -5.19 [-14.00; 3.62] | 0.273 | 0.849 | 0.128 | 0.140 | ||
Tape & Malllinckrodt
| 0.80 [-5.54; 7.14] | -0.13 [-6.74; 6.49] | 5.07 [-4.29; 14.42] | 0.246 |
0.003
|
0.008
| ||
Twill & Mallinckrodt
| -3.40 [-9.62; 2.81] | -4.33 [-10.83; 2.17] | 0.86 [-8.42; 10.14] | -4.21 [-11.5; 3.09] |
0.035
| 0.060 | ||
Tape & Securisyn
| -11.49 [-18.05; -4.92] | -12.42 [-19.25; -5.59] | -7.22 [-16.71; 2.26] | -12.29 [-19.87; -4.71] | -8.08 [-15.56; -0.60] | 0.857 | ||
Twill & Securisyn
| -12.32 [-21.00; -3.65] | -13.5 [-22.10; -4.40] | -8.06 [-18.94; 2.82] | -13.12 [-22.51; -3.73] | -8.92 [-18.24; 0.40] | -0.83 [-10.35; 8.69] | ||
Difference between means and 95% confidence interval
|
Failure modes
Mode | SolidAIRity® | Thomas™ | Anchor Fast | Tape & Mallinckrodt tube | Twill & Mallinckrodt tube | Tape & Securisyn tube | Twill & Securisyn tube |
---|---|---|---|---|---|---|---|
1
|
Tube slipped through stabilizer: Ribs on the tube would deform and flatten out enough to slide through the stabilization device. Loading from any angles except center would sometimes cause the stabilizer parts to separate (splay) enough for the tube to slip through (Test points 1, 2, 3, 4, 6, 9, 11, 12). |
Tube slipped through clamp: This mode of failure did not result in any damage to the device rather it just failed to prevent tube motion by allowing the tube to slide through the clamp mechanism. |
Clip broke at attachment point of sliding member: A feature for lateral adjustment of tube placement is included with this device. It consists of a clip that slides along a bar. This clip would fail catastrophically, with pieces breaking off (test points 1, 2, 3, 4, 6, 7, 8, 9, 11). |
Tape tore between tube and cheek: All angles demonstrated same failure mechanism of tape tearing. |
Knot lost Tension: All failures were the same. |
Tape tore between tube and cheek or at tape-tube interface: All angles demonstrated same failure mechanism of the tape tearing where it came in contact with the ribs of the ET tube. |
Knot lost Tension: All tests that failed exhibited a gradual loss in knot tension and progressive slipping of the tube through the knot. Certain angles allowed the knot to maintain tension generating very large force values (test points 2, 7, 9, 11). |
2
| Depending upon angle of force application, at very large loads (>200 N) sometimes the entire stabilization device would fail by cracking of the plastic stabilization pieces (Test points 5, 7, 8, 10, 13). |
Clip slid off bar: Alternatively, the clip mechanism would fail by sliding off the end of the bar on which it travels (test point 13) or both slide off and break (test point 10). |
Discussion
Conclusions
Key messages
-
Force data can aid in optimization of use, and development of new, methods for endotracheal tube fixation
-
Forces required to displace an endotracheal tube depend upon the angle at which the forces are applied
-
Force values and standard deviations for extubation vary significantly with method used and angle of applied force
-
When evaluating methods of endotracheal tube restraint, standard deviation could be used as a measure of method reliability
-
Significant differences in standard deviations were observed between methods of fixation and angle of force application