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. 2021 Dec 15:8:767182.
doi: 10.3389/fmed.2021.767182. eCollection 2021.

Tracheal Tube-Mounted Camera Assisted Intubation vs. Videolaryngoscopy in Expected Difficult Airway: A Prospective, Randomized Trial (VivaOP Trial)

Jörn Grensemann  1 , Emma Möhlenkamp  1 , Philipp Breitfeld  1 , Pischtaz A Tariparast  1 , Tanja Peters  1 , Mark A Punke  1 , Stefan Kluge  1 , Martin Petzoldt  1
Affiliations

Tracheal Tube-Mounted Camera Assisted Intubation vs. Videolaryngoscopy in Expected Difficult Airway: A Prospective, Randomized Trial (VivaOP Trial)

Jörn Grensemann et al. Front Med (Lausanne). .

Abstract

Background: Tracheal intubation in patients with an expected difficult airway may be facilitated by videolaryngoscopy (VL). The VL viewing axis angle is specified by the blade shape and visualization of the larynx may fail if the angle does not meet anatomy of the patient. A tube with an integrated camera at its tip (VST, VivaSight-SL) may be advantageous due to its adjustable viewing axis by means of angulating an included stylet. Methods: With ethics approval, we studied the VST vs. VL in a prospective non-inferiority trial using end-tidal oxygen fractions (etO2) after intubation, first-attempt success rates (FAS), visualization assessed by the percentage of glottis opening (POGO) scale, and time to intubation (TTI) as outcome parameters. Results: In this study, 48 patients with a predicted difficult airway were randomized 1:1 to intubation with VST or VL. Concerning oxygenation, the VST was non-inferior to VL with etO2 of 0.79 ± 0.08 (95% CIs: 0.75-0.82) vs. 0.81 ± 0.06 (0.79-0.84) for the VL group, mean difference 0.02 (-0.07 to 0.02), p = 0.234. FAS was 79% for VST and 88% for VL (p = 0.449). POGO was 89 ± 21% in the VST-group and 60 ± 36% in the VL group, p = 0.002. TTI was 100 ± 57 s in the VST group and 68 ± 65 s in the VL group (p = 0.079). TTI with one attempt was 84 ± 31 s vs. 49 ± 14 s, p < 0.001. Conclusion: In patients with difficult airways, tracheal intubation with the VST is feasible without negative impact on oxygenation, improves visualization but prolongs intubation. The VST deserves further study to identify patients that might benefit from intubation with VST.

Keywords: VivaSight; airway management (MeSH); intubation (intratracheal); laryngoscope and intubation; laryngoscopy; respiration (artificial).

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Conflict of interest statement

JG has received research support from Adroit Surgical, Ambu, ETView, and Infectopharm, and received consultant and lecture fees from Drägerwerk, Fresenius Medical, GE Healthcare, and Smith Medical; SK received research support from Ambu, Daiichi Sankyo, ETView Ltd., Fisher & Paykel, Pfizer, and Xenios, lecture fees from Astra, C.R.Bard, Baxter, Biotest, Cytosorbents, Daiichi Sankyo, Fresenius, Gilead, Mitsubishi Tanabe Pharma, MSD, Pfizer, Philips, and Zoll, and consultant fees from Bayer, Fresenius, Gilead, MSD, and Pfizer; MP received a research grant awarded by Verathon. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Depiction of the setup of VivaSight-SL tubes. Prepared “optimal” stylet angulation achieved by superposition of 60 intubations in a pretrial manikin training (prepared for difficult airways) by 15 operators. VivaSight-SL tube connected to aView monitor; arrow indicates camera rinsing port; inset depicts camera of tube.
Figure 2
Figure 2
CONSORT diagram. RSI, rapid sequence induction.
Figure 3
Figure 3
Overview of success rate, oxygenation, visualization, and duration for VivaSight and videolaryngoscopy. FAS, first attempt success rate; etO2, end-tidal oxygen fraction after intubation; POGO, percentage of glottis opening scale; TTI 1st, time to intubation with success in the first attempt. Error bars indicate 95% CIs; n.s., not statistically significant.
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