Randomized Controlled Trial

. 2021 Jun;47(6):653-664.

doi: 10.1007/s00134-021-06417-y. Epub 2021 May 25.

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^{1

2}, Amélie Rollé³, Thomas Godet⁴, Nicolas Terzi⁵, Béatrice Riu⁶, Pierre Asfar⁷, Jeremy Bourenne⁸, Séverin Ramin⁹, Virginie Lemiale¹⁰, Jean-Pierre Quenot^{11

12

13}, Christophe Guitton¹⁴, Eloi Prudhomme^{15

16}, Cyril Quemeneur¹⁷, Raiko Blondonnet⁴, Mathieu Biais^{18

19}, Laurent Muller²⁰, Alexandre Ouattara^{21

22}, Martine Ferrandiere²³, Piehr Saint-Léger²⁴, Thomas Rimmelé²⁵, Julien Pottecher²⁶, Gerald Chanques²⁷, Fouad Belafia²⁷, Claire Chauveton^{28

29}, Helena Huguet^{30

29}, Karim Asehnoune³¹, Emmanuel Futier⁴, Elie Azoulay¹⁰, Nicolas Molinari²³, Audrey De Jong²⁷; STYLETO trial group

Collaborators, Affiliations

Collaborators

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

Affiliations

¹ Department of Anesthesia and Intensive Care Unit, Regional University Hospital of Montpellier, St-Eloi Hospital, University of Montpellier, PhyMedExp, INSERM U1046, CNRS UMR, 9214, Montpellier Cedex 5, France. s-jaber@chu-montpellier.fr.
² Département d'Anesthésie Réanimation B (DAR B), Hôpital Saint-Eloi, 80 Avenue Augustin Fliche, 34295, Montpellier, France. s-jaber@chu-montpellier.fr.
³ Department of Intensive Care, Guadeloupe University Hospital, French Caribbean, France.
⁴ Department of Peri-Operative Medicine, CHU Clermont-Ferrand, 63000, Clermont-Ferrand, France.
⁵ Department of Medical Intensive Care, CHU de Grenoble-Alpes, 38000, Grenoble, France.
⁶ Critical Care Unit, University Teaching Hospital of Purpan, Place du Dr Baylac, 31059, Toulouse Cedex 9, France.
⁷ Département de Médecine Intensive-Réanimation, CHU d'Angers, Université d'Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.
⁸ AP-HM, Emergency and Critical Care Medicine, Aix Marseille University, University Hospital Timone, Marseille, France.
⁹ Anesthesiology and Intensive Care, Anesthesia and Critical Care Department A, Lapeyronie Teaching Hospital, Montpellier Cedex 5, France.
¹⁰ Médecine Intensive et Réanimation, Groupe FAMIREA, Hôpital Saint-Louis, Université de Paris, Paris, France.
¹¹ Department of Intensive Care, François-Mitterrand University Hospital, 14, rue Paul Gaffarel, 21000, Dijon, France.
¹² Lipness Team, Inserm Research Center LNC-UMR1231 and LabExLipSTIC, University of Burgundy, 21000, Dijon, France.
¹³ Inserm CIC 1432, Clinical Epidemiology, University, Dijon, France.
¹⁴ Intensive Care Unit, General Hospital Center, Le Mans, France.
¹⁵ Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Médecine Intensive Réanimation, 13015, Marseille, France.
¹⁶ Centre d'Études et de Recherches sur les Services de Santé et qualité de vie EA 3279, Aix-Marseille Université, Faculté de Médecine, 13005, Marseille, France.
¹⁷ Department of Anaesthesiology and Critical Care, Sorbonne University, GRC 29, AP-HP, DMU DREAM, Pitié-Salpêtrière Hospital, Paris, France.
¹⁸ Anesthesiology and Critical Care Department, CHU Bordeaux, 33000, Bordeaux, France.
¹⁹ Univ. Bordeaux Segalen, 33000, Bordeaux, France.
²⁰ Department of Intensive Care, Nîmes University Hospital, Nîmes, France.
²¹ Department of Anaesthesia and Critical Care, CHU Bordeaux,, Magellan Medico-Surgical Centre, 33000, Bordeaux, France.
²² Univ. Bordeaux, INSERM, UMR 1034, Biology of Cardiovascular Diseases, 33600, Pessac, France.
²³ Département Anesthésie Réanimation, Université de Tours, CHU de Tours, Tours, France.
²⁴ Department of Intensive Care, General Hospital Center, Valenciennes, France.
²⁵ Department of Anesthesiology and Intensive Care Medicine, Edouard Herriot Hospital, Hospices Civils de Lyon, University Claude Bernard Lyon 1, EA, 7426, Lyon, France.
²⁶ Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre, Service d'Anesthésie-Réanimation & Médecine Péri-Opératoire-Université de Strasbourg, FMTS, EA3072, Strasbourg, France.
²⁷ Department of Anesthesia and Intensive Care Unit, Regional University Hospital of Montpellier, St-Eloi Hospital, University of Montpellier, PhyMedExp, INSERM U1046, CNRS UMR, 9214, Montpellier Cedex 5, France.
²⁸ Clinical Research Department of Montpellier University Hospital, Montpellier, France.
²⁹ Universite de Montpellier, Montpellier, Languedoc-Roussillon, France.
³⁰ IMAG, CNRS, Univ Montpellier, CHU Montpellier, Montpellier, France.
³¹ Department of Anaesthesia and Critical Care, Hôtel Dieu, University Hospital of Nantes, Nantes, France.

PMID: 34032882
PMCID: PMC8144872
DOI: 10.1007/s00134-021-06417-y

Randomized Controlled Trial

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 et al. Intensive Care Med. 2021 Jun.

. 2021 Jun;47(6):653-664.

doi: 10.1007/s00134-021-06417-y. Epub 2021 May 25.

Authors

Collaborators

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

Affiliations

¹ Department of Anesthesia and Intensive Care Unit, Regional University Hospital of Montpellier, St-Eloi Hospital, University of Montpellier, PhyMedExp, INSERM U1046, CNRS UMR, 9214, Montpellier Cedex 5, France. s-jaber@chu-montpellier.fr.
² Département d'Anesthésie Réanimation B (DAR B), Hôpital Saint-Eloi, 80 Avenue Augustin Fliche, 34295, Montpellier, France. s-jaber@chu-montpellier.fr.
³ Department of Intensive Care, Guadeloupe University Hospital, French Caribbean, France.
⁴ Department of Peri-Operative Medicine, CHU Clermont-Ferrand, 63000, Clermont-Ferrand, France.
⁵ Department of Medical Intensive Care, CHU de Grenoble-Alpes, 38000, Grenoble, France.
⁶ Critical Care Unit, University Teaching Hospital of Purpan, Place du Dr Baylac, 31059, Toulouse Cedex 9, France.
⁷ Département de Médecine Intensive-Réanimation, CHU d'Angers, Université d'Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.
⁸ AP-HM, Emergency and Critical Care Medicine, Aix Marseille University, University Hospital Timone, Marseille, France.
⁹ Anesthesiology and Intensive Care, Anesthesia and Critical Care Department A, Lapeyronie Teaching Hospital, Montpellier Cedex 5, France.
¹⁰ Médecine Intensive et Réanimation, Groupe FAMIREA, Hôpital Saint-Louis, Université de Paris, Paris, France.
¹¹ Department of Intensive Care, François-Mitterrand University Hospital, 14, rue Paul Gaffarel, 21000, Dijon, France.
¹² Lipness Team, Inserm Research Center LNC-UMR1231 and LabExLipSTIC, University of Burgundy, 21000, Dijon, France.
¹³ Inserm CIC 1432, Clinical Epidemiology, University, Dijon, France.
¹⁴ Intensive Care Unit, General Hospital Center, Le Mans, France.
¹⁵ Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Médecine Intensive Réanimation, 13015, Marseille, France.
¹⁶ Centre d'Études et de Recherches sur les Services de Santé et qualité de vie EA 3279, Aix-Marseille Université, Faculté de Médecine, 13005, Marseille, France.
¹⁷ Department of Anaesthesiology and Critical Care, Sorbonne University, GRC 29, AP-HP, DMU DREAM, Pitié-Salpêtrière Hospital, Paris, France.
¹⁸ Anesthesiology and Critical Care Department, CHU Bordeaux, 33000, Bordeaux, France.
¹⁹ Univ. Bordeaux Segalen, 33000, Bordeaux, France.
²⁰ Department of Intensive Care, Nîmes University Hospital, Nîmes, France.
²¹ Department of Anaesthesia and Critical Care, CHU Bordeaux,, Magellan Medico-Surgical Centre, 33000, Bordeaux, France.
²² Univ. Bordeaux, INSERM, UMR 1034, Biology of Cardiovascular Diseases, 33600, Pessac, France.
²³ Département Anesthésie Réanimation, Université de Tours, CHU de Tours, Tours, France.
²⁴ Department of Intensive Care, General Hospital Center, Valenciennes, France.
²⁵ Department of Anesthesiology and Intensive Care Medicine, Edouard Herriot Hospital, Hospices Civils de Lyon, University Claude Bernard Lyon 1, EA, 7426, Lyon, France.
²⁶ Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre, Service d'Anesthésie-Réanimation & Médecine Péri-Opératoire-Université de Strasbourg, FMTS, EA3072, Strasbourg, France.
²⁷ Department of Anesthesia and Intensive Care Unit, Regional University Hospital of Montpellier, St-Eloi Hospital, University of Montpellier, PhyMedExp, INSERM U1046, CNRS UMR, 9214, Montpellier Cedex 5, France.
²⁸ Clinical Research Department of Montpellier University Hospital, Montpellier, France.
²⁹ Universite de Montpellier, Montpellier, Languedoc-Roussillon, France.
³⁰ IMAG, CNRS, Univ Montpellier, CHU Montpellier, Montpellier, France.
³¹ Department of Anaesthesia and Critical Care, Hôtel Dieu, University Hospital of Nantes, Nantes, France.

PMID: 34032882
PMCID: PMC8144872
DOI: 10.1007/s00134-021-06417-y

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.

PubMed Disclaimer

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**
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**
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**
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

See this image and copyright information in PMC

Comment in

Use of stylet and airway management procedure in critically ill patients.
Masuda T, Nosaka N, Uchimido R, Nagashima M. Masuda T, et al. Intensive Care Med. 2021 Dec;47(12):1497-1498. doi: 10.1007/s00134-021-06476-1. Epub 2021 Jul 10. Intensive Care Med. 2021. PMID: 34245314 No abstract available.
Intubation in intensive care unit: Is it time to update guidelines?
Quintard H. Quintard H. Anaesth Crit Care Pain Med. 2021 Oct;40(5):100946. doi: 10.1016/j.accpm.2021.100946. Epub 2021 Aug 31. Anaesth Crit Care Pain Med. 2021. PMID: 34478873 No abstract available.
Use of stylet and airway management procedure in critically ill patients. Author's reply.
Jaber S, De Jong A. Jaber S, et al. Intensive Care Med. 2021 Dec;47(12):1499-1500. doi: 10.1007/s00134-021-06518-8. Epub 2021 Sep 14. Intensive Care Med. 2021. PMID: 34522982 No abstract available.
Securing the airway in critical care scenarios: questioning the fundamentals.
Bhakta P, Walsh S, Karim HMR, Mugawar M, O'Brien B. Bhakta P, et al. Intensive Care Med. 2021 Dec;47(12):1501-1502. doi: 10.1007/s00134-021-06547-3. Epub 2021 Oct 5. Intensive Care Med. 2021. PMID: 34609550 No abstract available.
[Focus ventilation, oxygen therapy and weaning : Intensive medical care studies from 2020/2021].
Fiedler MO, Reuß CJ, Bernhard M, Beynon C, Hecker A, Jungk C, Nusshag C, Michalski D, Brenner T, Weigand MA, Dietrich M. Fiedler MO, et al. Anaesthesist. 2021 Nov;70(11):967-976. doi: 10.1007/s00101-021-00979-8. Epub 2021 Oct 6. Anaesthesist. 2021. PMID: 34613457 Free PMC article. German. No abstract available.
Securing the airway in critical care scenarios-questioning the fundamentals Author's reply.
Jaber S, De Jong A. Jaber S, et al. Intensive Care Med. 2021 Dec;47(12):1503-1504. doi: 10.1007/s00134-021-06552-6. Epub 2021 Nov 2. Intensive Care Med. 2021. PMID: 34727213 No abstract available.

References

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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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

Comment in

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

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Medical