Effect of endotracheal tube plus stylet versus endotracheal tube alone on successful first-attempt tracheal intubation among critically ill patients: the multicentre randomised STYLETO study protocol. 2020

Samir Jaber, and Amélie Rolle, and Boris Jung, and Gerald Chanques, and Helena Bertet, and David Galeazzi, and Claire Chauveton, and Nicolas Molinari, and Audrey De Jong
Department of Anaesthesiology and Critical Care Medicine B (DAR B), Saint-Eloi Hospital, University Teaching Hospital of Montpellier, 80 avenue Augustin Fliche, 34295 Montpellier, France, Universite de Montpellier, Montpellier, Languedoc-Roussillon, France s-jaber@chu-montpellier.fr.

Tracheal intubation is one of the most daily practiced procedures performed in intensive care unit (ICU). It is associated with severe life-threatening complications, which can lead to intubation-related cardiac arrest. Using a preshaped endotracheal tube plus stylet may have potential advantages over endotracheal tube without stylet. The stylet is a rigid but malleable introducer which fits inside the endotracheal tube and allows for manipulation of the tube shape; to facilitate passage of the tube through the laryngeal inlet. However, some complications from stylets have been reported including mucosal bleeding, perforation of the trachea or oesophagus and sore throat. The use of a stylet for first-attempt intubation has never been assessed in ICU and benefit remains to be established. The endotracheal tube plus stylet to increase first-attempt success during orotracheal intubation compared with endotracheal tube alone in ICU patients (STYLETO) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation. Patients will be randomly assigned to undergo the initial intubation attempt with endotracheal tube alone (ie,without stylet, control group) or endotracheal tube + stylet (experimental group). The primary outcome is the proportion of patients with successful first-attempt orotracheal intubation. The single, prespecified, secondary outcome is the incidence of complications related to intubation, in the hour following intubation. Other outcomes analysed will include safety, exploratory procedural and clinical outcomes. The study project has been approved by the appropriate ethics committee 'Comité-de-Protection-des-Personnes Nord-Ouest3-19.04.26.65808 Cat2 RECHMPL19_0216/STYLETO2019-A01180-57'". Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If combined use of endotracheal tube plus stylet facilitates tracheal intubation of ICU patients compared with endotracheal tube alone, its use will become standard practice, thereby decreasing first-attempt intubation failure rates and, potentially, the frequency of intubation-related complications. ClinicalTrials.gov Identifier: NCT04079387; Pre-results.

UI MeSH Term Description Entries
D007362 Intensive Care Units Hospital units providing continuous surveillance and care to acutely ill patients. ICU Intensive Care Units,Intensive Care Unit,Unit, Intensive Care
D007442 Intubation, Intratracheal A procedure involving placement of a tube into the trachea through the mouth or nose in order to provide a patient with oxygen and anesthesia. Intubation, Endotracheal,Endotracheal Intubation,Endotracheal Intubations,Intratracheal Intubation,Intratracheal Intubations,Intubations, Endotracheal,Intubations, Intratracheal
D007830 Larynx A tubular organ of VOICE production. It is located in the anterior neck, superior to the TRACHEA and inferior to the tongue and HYOID BONE. Anterior Commissure, Laryngeal,Anterior Commissure, Larynx,Laryngeal Anterior Commissure,Laryngeal Posterior Commissure,Posterior Commissure, Laryngeal,Posterior Commissure, Larynx,Anterior Commissures, Laryngeal,Anterior Commissures, Larynx,Commissure, Laryngeal Anterior,Commissure, Laryngeal Posterior,Commissure, Larynx Anterior,Commissure, Larynx Posterior,Commissures, Laryngeal Anterior,Commissures, Laryngeal Posterior,Commissures, Larynx Anterior,Commissures, Larynx Posterior,Laryngeal Anterior Commissures,Laryngeal Posterior Commissures,Larynx Anterior Commissure,Larynx Anterior Commissures,Larynx Posterior Commissure,Larynx Posterior Commissures,Posterior Commissures, Laryngeal,Posterior Commissures, Larynx
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014132 Trachea The cartilaginous and membranous tube descending from the larynx and branching into the right and left main bronchi. Tracheas
D015337 Multicenter Studies as Topic Works about controlled studies which are planned and carried out by several cooperating institutions to assess certain variables and outcomes in specific patient populations, for example, a multicenter study of congenital anomalies in children. Multicenter Trials,Multicentre Studies as Topic,Multicentre Trials,Multicenter Trial,Multicentre Trial,Trial, Multicenter,Trial, Multicentre,Trials, Multicenter,Trials, Multicentre
D016032 Randomized Controlled Trials as Topic Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table. Clinical Trials, Randomized,Controlled Clinical Trials, Randomized,Trials, Randomized Clinical
D016638 Critical Illness A disease or state in which death is possible or imminent. Critically Ill,Critical Illnesses,Illness, Critical,Illnesses, Critical

Related Publications

Samir Jaber, and Amélie Rolle, and Boris Jung, and Gerald Chanques, and Helena Bertet, and David Galeazzi, and Claire Chauveton, and Nicolas Molinari, and Audrey De Jong
April 2022, JAMA,
Samir Jaber, and Amélie Rolle, and Boris Jung, and Gerald Chanques, and Helena Bertet, and David Galeazzi, and Claire Chauveton, and Nicolas Molinari, and Audrey De Jong
April 2022, JAMA,
Samir Jaber, and Amélie Rolle, and Boris Jung, and Gerald Chanques, and Helena Bertet, and David Galeazzi, and Claire Chauveton, and Nicolas Molinari, and Audrey De Jong
April 2022, JAMA,
Samir Jaber, and Amélie Rolle, and Boris Jung, and Gerald Chanques, and Helena Bertet, and David Galeazzi, and Claire Chauveton, and Nicolas Molinari, and Audrey De Jong
December 2021, JAMA,
Samir Jaber, and Amélie Rolle, and Boris Jung, and Gerald Chanques, and Helena Bertet, and David Galeazzi, and Claire Chauveton, and Nicolas Molinari, and Audrey De Jong
June 2021, Intensive care medicine,
Samir Jaber, and Amélie Rolle, and Boris Jung, and Gerald Chanques, and Helena Bertet, and David Galeazzi, and Claire Chauveton, and Nicolas Molinari, and Audrey De Jong
October 2018, Annals of internal medicine,
Samir Jaber, and Amélie Rolle, and Boris Jung, and Gerald Chanques, and Helena Bertet, and David Galeazzi, and Claire Chauveton, and Nicolas Molinari, and Audrey De Jong
March 2009, Acta anaesthesiologica Scandinavica,
Samir Jaber, and Amélie Rolle, and Boris Jung, and Gerald Chanques, and Helena Bertet, and David Galeazzi, and Claire Chauveton, and Nicolas Molinari, and Audrey De Jong
December 2018, JMIR research protocols,
Samir Jaber, and Amélie Rolle, and Boris Jung, and Gerald Chanques, and Helena Bertet, and David Galeazzi, and Claire Chauveton, and Nicolas Molinari, and Audrey De Jong
June 2018, JAMA,
Samir Jaber, and Amélie Rolle, and Boris Jung, and Gerald Chanques, and Helena Bertet, and David Galeazzi, and Claire Chauveton, and Nicolas Molinari, and Audrey De Jong
June 2023, Annals of emergency medicine,
Copied contents to your clipboard!