Effect of the use of an endotracheal tube and stylet versus an endotracheal tube alone on first-attempt intubation success: a multicentre, randomised clinical trial in 999 patients

Samir Jaber, Amélie Rollé, Thomas Godet, Nicolas Terzi, Béatrice Riu, Pierre Asfar, Jeremy Bourenne, Séverin Ramin, Virginie Lemiale, Jean-Pierre Quenot, Christophe Guitton, Eloi Prudhomme, Cyril Quemeneur, Raiko Blondonnet, Mathieu Biais, Laurent Muller, Alexandre Ouattara, Martine Ferrandiere, Piehr Saint-Léger, Thomas Rimmelé, Julien Pottecher, Gerald Chanques, Fouad Belafia, Claire Chauveton, Helena Huguet, Karim Asehnoune, Emmanuel Futier, Elie Azoulay, Nicolas Molinari, Audrey De Jong, STYLETO trial group, Samir Jaber, Gérald Chanques, Fouad Belafia, Audrey De Jong, Séverin Ramin, Xavier Capdevila, Jonathan Charbit, Amélie Rollé, Michel Carles, Thomas Godet, Matthieu Jabaudon, Emmanuel Futier, Raiko Blondonnet, Bertrand Souweine, Nicolas Terzi, Charlotte Cordier, Florian Sigaud, Béatrice Riu, Pierre Asfar, Sigismond Lasocki, Jeremy Bourenne, Marc Gainnier, Laurent Papazian, Eloi Prudhomme, Djamel Mokart, Marc Léone, Virginie Lemiale, Elie Azoulay, Jean-Pierre Quenot, Pascal Andreu, Marie Labruyère, Jean-Baptiste Roudaut, Marine Jacquier, Christophe Guitton, Mona Assefi, Elodie Baron, Cyril Quemeneur, Jean-Michel Constantin, Matthieu Biais, Hadrien Rozé, Alexandre Ouattara, Martin Mahul, Laurent Muller, Jean-Yves Lefrant, Claire Roger, Saber Barbar, Martine Ferrandière, Fabien Lambiotte, Piehr Saint-Léger, Thomas Rimmelé, Céline Monard, Paul Abraham, Julien Pottecher, Pierre-Olivier Ludes, Karim Asehnoune, Emmanuel Pardo, Marc Garnier, Matthias Garot, Anne Bignon, Benoit Tavernier, Benjamin Chousterman, Etienne Gayat, Bruno Levy, Jean Dellamonica, Samir Jaber, Amélie Rollé, Thomas Godet, Nicolas Terzi, Béatrice Riu, Pierre Asfar, Jeremy Bourenne, Séverin Ramin, Virginie Lemiale, Jean-Pierre Quenot, Christophe Guitton, Eloi Prudhomme, Cyril Quemeneur, Raiko Blondonnet, Mathieu Biais, Laurent Muller, Alexandre Ouattara, Martine Ferrandiere, Piehr Saint-Léger, Thomas Rimmelé, Julien Pottecher, Gerald Chanques, Fouad Belafia, Claire Chauveton, Helena Huguet, Karim Asehnoune, Emmanuel Futier, Elie Azoulay, Nicolas Molinari, Audrey De Jong, STYLETO trial group, Samir Jaber, Gérald Chanques, Fouad Belafia, Audrey De Jong, Séverin Ramin, Xavier Capdevila, Jonathan Charbit, Amélie Rollé, Michel Carles, Thomas Godet, Matthieu Jabaudon, Emmanuel Futier, Raiko Blondonnet, Bertrand Souweine, Nicolas Terzi, Charlotte Cordier, Florian Sigaud, Béatrice Riu, Pierre Asfar, Sigismond Lasocki, Jeremy Bourenne, Marc Gainnier, Laurent Papazian, Eloi Prudhomme, Djamel Mokart, Marc Léone, Virginie Lemiale, Elie Azoulay, Jean-Pierre Quenot, Pascal Andreu, Marie Labruyère, Jean-Baptiste Roudaut, Marine Jacquier, Christophe Guitton, Mona Assefi, Elodie Baron, Cyril Quemeneur, Jean-Michel Constantin, Matthieu Biais, Hadrien Rozé, Alexandre Ouattara, Martin Mahul, Laurent Muller, Jean-Yves Lefrant, Claire Roger, Saber Barbar, Martine Ferrandière, Fabien Lambiotte, Piehr Saint-Léger, Thomas Rimmelé, Céline Monard, Paul Abraham, Julien Pottecher, Pierre-Olivier Ludes, Karim Asehnoune, Emmanuel Pardo, Marc Garnier, Matthias Garot, Anne Bignon, Benoit Tavernier, Benjamin Chousterman, Etienne Gayat, Bruno Levy, Jean Dellamonica

Abstract

Purpose: The effect of the routine use of a stylet during tracheal intubation on first-attempt intubation success is unclear. We hypothesised that the first-attempt intubation success rate would be higher with tracheal tube + stylet than with tracheal tube alone.

Methods: In this multicentre randomised controlled trial, conducted in 32 intensive care units, we randomly assigned patients to tracheal tube + stylet or tracheal tube alone (i.e. without stylet). The primary outcome was the proportion of patients with first-attempt intubation success. The secondary outcome was the proportion of patients with complications related to tracheal intubation. Serious adverse events, i.e., traumatic injuries related to tracheal intubation, were evaluated.

Results: A total of 999 patients were included in the modified intention-to-treat analysis: 501 (50%) to tracheal tube + stylet and 498 (50%) to tracheal tube alone. First-attempt intubation success occurred in 392 patients (78.2%) in the tracheal tube + stylet group and in 356 (71.5%) in the tracheal tube alone group (absolute risk difference, 6.7; 95%CI 1.4-12.1; relative risk, 1.10; 95%CI 1.02-1.18; P = 0.01). A total of 194 patients (38.7%) in the tracheal tube + stylet group had complications related to tracheal intubation, as compared with 200 patients (40.2%) in the tracheal tube alone group (absolute risk difference, - 1.5; 95%CI - 7.5 to 4.6; relative risk, 0.96; 95%CI 0.83-1.12; P = 0.64). The incidence of serious adverse events was 4.0% and 3.6%, respectively (absolute risk difference, 0.4; 95%CI, - 2.0 to 2.8; relative risk, 1.10; 95%CI 0.59-2.06. P = 0.76).

Conclusions: Among critically ill adults undergoing tracheal intubation, using a stylet improves first-attempt intubation success.

Keywords: Acute respiratory failure; Airway; Complications; Critical care; Intensive care unit; Intubation; Stylet.

Conflict of interest statement

SJ reports receiving consulting fees from Drager, Medtronic, Baxter, Fresenius-Xenios, and Fisher & Paykel. TR is a paid consultant of bioMerieux and Baxter. He has received grant support from bioMerieux, Baxter and Fresenius Medical Care and fees for lectures during industry symposia for bioMerieux, Baxter, Fresenius Medical Care, Bbraun and Nikkiso. VL reported being a member of a research group that has received grants from Alexion, Baxter, MSD, Gilead, Sanofi, Celgène. ADJ reports receiving consulting fees from Medtronic. No conflict of interests is reported for other authors.

Figures

Fig. 1
Fig. 1
Flowchart of patients enrolled in the Styleto Trial. From October 1, 2019, to March 17, 2020, of the 1626 screened patients who met the inclusion criteria, 999 (61.4%) met no exclusion criteria and were enrolled
Fig. 2
Fig. 2
First-attempt intubation success and Complications related to Intubation. The percentages of patients who had the primary outcome, i.e., first-attempt intubation success, and the main secondary outcome, i.e., complications related to intubation are shown in each group. The T bars represent the upper limit of the 95% confidence intervals for the event rate
Fig. 3
Fig. 3
Subgroup Analyses of the Primary Outcome. Shown is the absolute difference risk in the first-attempt intubation success rate between patients receiving tracheal tube + Stylet and those receiving tracheal tube alone in prespecified subgroups. The horizontal bars represent the 95% confidence intervals around the absolute difference. The number of patients in each group is shown. SAPS Simplified Acute Physiologic Score; BIPAP Bilevel Positive Airway Pressure; MACOCHA Mallampati score III or IV, obstructive sleep Apnea syndrome, reduced mobility of Cervical spine, limited mouth Opening, severe Hypoxemia, Coma, non-Anesthesiologist

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