Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone (STYLETO)

Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone on Successful First-Pass Orotracheal Intubation Among Critically Ill Patients: the Randomised STYLETO Study Protocol"

Patients admitted to Intensive Care Units (ICU) often require respiratory support. Orotracheal intubation is one of the most frequent procedures performed in ICU.When performed in emergency settings, intubation is a challenging issue as it may be associated with life-threatening complications in up to one third of cases

Using a preshaped endotracheal tube plus stylet may have potential advantages over endotracheal tube alone without stylet. The stylet is a rigid but malleable introducer which fits inside the endotracheal tube and allows for manipulation of the tube shape; usually into a hockey stick shape, to facilitate passage of the tube through the laryngeal inlet. The stylet can help to increase success of intubation in operating rooms

Study Overview

• Status: Completed
• Conditions: Critically Ill; Intubation Complication
• Intervention / Treatment: Device: ENDOTRACHEAL TUBE + STYLET; Device: ENDOTRACHEAL TUBE ALONE

Detailed Description

Patients admitted to Intensive Care Units (ICU) often require respiratory support. Orotracheal intubation is one of the most frequent procedures performed in ICU. When performed in emergency settings, intubation is a challenging issue as it may be associated with life-threatening complications in up to one third of cases.Severe hypoxaemia occurring during intubation procedure can result in cardiac arrest,cerebral anoxia, and death.Difficult intubation is known to be associated with life-threatening complications both in operating room and in emergent conditions.ICU intubation conditions are worse than intubation conditions in operative rooms.A non-planned and urgent intubation procedure, severity of patient disease and ergonomic issues explain the morbidity associated with intubation in ICU.To prevent and limit the incidence of severe hypoxemia following intubation and its complications, several intubation algorithms have been developed ,and specific risk factors for difficult intubation in ICU have been identified.

In 2018, a large multicenter study reported first-attempt intubation success rates using direct laryngoscopy of 70% and videolaryngoscopy of 67%. In 2019, a multicentre randomized trial,assessing whether positive-pressure ventilation with a bag-mask device (bag-mask ventilation) during tracheal intubation of critically ill adults prevents hypoxemia, reported a first-attempt success rate of 81%. Other authors reported an overall first-attempt intubation success rate of 74%. The 20% to 40% first-attempt failure rates throughout studies highlight the opportunity to improve the safety and efficiency of this critical procedure. Using a preshaped endotracheal tube plus stylet may have potential advantages over endotracheal tube alone without stylet. The stylet is a rigid but malleable introducer which fits inside the endotracheal tube and allows for manipulation of the tube shape; usually into a hockey stick shape, to facilitate passage of the tube through the laryngeal inlet. The stylet can help to increase success of intubation in operating rooms.

However, some complications from intubating stylets have been reported including mucosal bleeding, perforation of the trachea or esophagus, and sore throat. In 2018, one study has assessed the effect of adding a stylet in case of difficult intubation in prehospital setting.However, in ICU, the systematic use of a stylet is still debated and recent recommendations do not recommend to use or not to use such devices for first-pass intubation. The device chosen for intubation may therefore be a confounding factor between the relation of stylet use and first-attempt success.The routine use of a stylet for first-pass intubation using laryngoscopes in ICU has never been assessed and benefit remains to be established.

The investigators hypothesis that adding stylet to endotracheal tube will increase the frequency of successful first-pass intubation compared with use endotracheal tube alone (i.e, without stylet) in ICU patients needing mechanical ventilation.

• Study Type: Interventional
• Enrollment (Actual): 1040
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Languedoc-Roussillon
    • Montpellier, Languedoc-Roussillon, France, 34295
      • Centre Hospitalier Universitaire Montpellier, Saint Eloi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients must be present in the intensive care unit (ICU) and require mechanical ventilation through an orotracheal tube.
• Adult (age ≥ 18 years)
• Subjects must be covered by public health insurance
• Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

Exclusion Criteria:

• Refusal of study participation or to pursue the study by the patient
• Pregnancy or breastfeeding
• Absence of coverage by the French statutory healthcare insurance system
• protected person
• intubation in case of cardio circulatory arrest
• Previous intubation during the same ICU stay and already included in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ENDOTRACHEAL TUBE + STYLET; The experimental group consists in intubating the trachea with an endotracheal tube + stylet with a "straight-to-cuff" shape and a bend angle of 25° to 35°.	Device: ENDOTRACHEAL TUBE + STYLET; The experimental group consists in intubating the trachea with an endotracheal tube + stylet with a "straight-to-cuff" shape and a bend angle of 25° to 35°
Active Comparator: ENDOTRACHEAL TUBE ALONE; The control group consists in intubating the trachea with an endotracheal tube alone (i.e, without stylet).	Device: ENDOTRACHEAL TUBE ALONE; intubating the trachea with an endotracheal tube alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with successful first-pass orotracheal intubation	the proportion of patients with successful first-pass orotracheal intubation	At intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications related to intubation	severe hypoxemia defined by lowest oxygen saturation (SpO2) < 80 %, severe cardiovascular collapse, defined as systolic blood pressure less than 65 mm Hg recorded at least once or less than 90 mm Hg lasting 30 minutes despite 500-1,000 ml of fluid loading (crystalloids solutions) or requiring introduction or increasing doses by more than 30% of vasoactive support, cardiac arrest, death during intubation; moderate: difficult intubation, severe ventricular or supraventricular arrhythmia requiring intervention, oesophageal intubation, agitation, pulmonary aspiration, dental injuries	1 hour after intubation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lowest SpO2 up to 24 hours after intubation	Assessment of the value of the lowest SpO2	up to 24 hours after intubation
Highest positive end expiratory pressure (PEEP) up to 24 hours after intubation	Assessment of the value of the highest PEEP	up to 24 hours after intubation
Highest fraction of inspired oxygen (FiO2) up to 24 hours after intubation	Assessment of the value of the highest FiO2	up to 24 hours after intubation
lowest SpO2 < 90%	incidence of lowest SpO2 less than 90% from induction to 2 minutes after intubation	during intubation
Change in SpO2	Change in SpO2 from SpO2 at induction to lowest SpO2	during intubation
desaturation	desaturation, defined as a change in SpO2 of more than 3% from induction to 2 minutes after intubation	during intubation
Cormack Lehane	Cormack-Lehane grade of glottic view	during intubation
difficulty of intubation	operator-assessed difficulty of intubation	during intubation
additional airway equipment or second operator	need for additional airway equipment or a second operator	during intubation
laryngoscopy attempts	number of laryngoscopy attempts	during intubation
Lowest SpO2 from 0-1 hour post intubation	Assessment of the value of the lowest SpO2 from 0-1 hours after intubation	up to 1 hour after intubation
Highest FiO2 from 0-1 hour post intubation	Assessment of the value of the highest FiO2 from 0-1 hours after intubation	up to 1 hour after intubation
Highest PEEP from 0-1 hour post intubation	Assessment of the value of the highest PEEP from 0-1 hours after intubation	up to 1 hour after intubation
Lowest SpO2 from 1-6 hours post intubation	Assessment of the value of the lowest SpO2 from 1-6 hours after intubation	From 1 to 6 hours after intubation
Highest FiO2 from 1-6 hours post intubation	Assessment of the value of the highest FiO2 from 1-6 hours after intubation	From 1 to 6 hours after intubation
Highest PEEP from 1-6 hours post intubation	Assessment of the value of the highest PEEP from 1-6 hours after intubation	From 1 to 6 hours after intubation
new infiltrate	new infiltrate on chest imaging in the 48 hours after intubation	Up to 48 hours after intubation
new pneumothorax	new pneumothorax on chest imaging in the 24 hours after intubation	Up to 24 hours after intubation
new pneumomediastinum	new pneumomediastinum on chest imaging in the 24 hours after intubation	Up to 24 hours after intubation
Intensive care unit (ICU) length of stay	ICU length of stay	Up to 90 days after intubation
ICU-free days	ICU-free days	Up to 90 days after intubation
invasive ventilator-free days	invasive ventilator-free days	Up to 90 days after intubation
mortality rate on day 28	mortality rate on day 28	Up to 28 days after intubation
In hospital mortality	in hospital mortality	Up to 90 days after intubation
mortality rate on day 90	mortality rate on day 90	Up to 90 days after intubation

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Publications and helpful links

General Publications

• Jaber S, Rolle A, Godet T, Terzi N, Riu B, Asfar P, Bourenne J, Ramin S, Lemiale V, Quenot JP, Guitton C, Prudhomme E, Quemeneur C, Blondonnet R, Biais M, Muller L, Ouattara A, Ferrandiere M, Saint-Leger P, Rimmele T, Pottecher J, Chanques G, Belafia F, Chauveton C, Huguet H, Asehnoune K, Futier E, Azoulay E, Molinari N, De Jong A; STYLETO trial group. 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. Intensive Care Med. 2021 Jun;47(6):653-664. doi: 10.1007/s00134-021-06417-y. Epub 2021 May 25.
• Jaber S, Rolle A, Jung B, Chanques G, Bertet H, Galeazzi D, Chauveton C, Molinari N, De Jong A. 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. BMJ Open. 2020 Oct 7;10(10):e036718. doi: 10.1136/bmjopen-2019-036718.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): March 17, 2020
• Study Completion (Actual): June 15, 2020

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness
• Other Study ID Numbers: RECHMPL19_0216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 12 months after the main publication
• IPD Sharing Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and institutional review board (IRB) review. Dataset will be shared after careful examination by the study board of investigators.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No