Table 2.
Primary and secondary outcome parameter(s) for the evaluation of the Provox Vega Puncture Set (PVPS) in comparison with the traditional Provox trocar and cannula method (PTCM); + favoring PVPS; = PVPS equals PTCM; − favoring PTCM; < easier/less time/less risk for PVPS; > less easy/more time/risk for PVPS
| Stage 1 (N = 20) | Stage 2 (N = 27) | |
|---|---|---|
| Primary outcome measure | ||
| Insertion in ‘one-go’ | 18 (90%) | 24 (89%) |
| Extra instruments | 18 none / 2 + 2 hemostats | 24 none / 2 + 2 hemostats / 1 + 3 hemostats |
| Secondary outcome measures | ||
| Mean time PVPSa | 110 s (SD = 48; range 60–224) | 155 s (SD = 116; range 58–600)b |
| Mean estimate PTCM | 201 s (SD = 66; range 90–360); P ≤ 0.0001 | 221 s (SD = 58; range 120–330); P = 0.002 |
| Appreciation | 18 + / 1 =/ 1 − | 25 + / 2 − |
| Ease of use | 17 < / 2 =/ 1 > | 26 < / 1 > |
| Time needed | 16 < / 3 =/ 1 > | 23 < / 3 =/1 > |
| Risk | 14 < / 5 =/ 1 missing | 20 < / 7 = |
| Preference | 17 + / 3 − | 26 + / 1 − |
aMean PVPS time for stage 1 and 2 is not significantly different (P = 0.115)
bThere were two outliers with 600 and 360 s, because of an unsuspected stenosis of the pharynx, which required dilatation first. Without those outliers, the mean PVPS time was 110 s with a range of 58–224 s. Mean PVPS time for stage 1 and 2 is again not significantly different (P = 0.268)