Skip to main content
OpenTrials
Completed

NCT Number: NCT04079387

Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Montpellier, Saint Eloi

Montpellier, Languedoc-Roussillon, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ENDOTRACHEAL TUBE + STYLET

Device

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°

ENDOTRACHEAL TUBE ALONE

Device

intubating the trachea with an endotracheal tube alone

Primary outcomes

  1. Number of patients with successful first-pass orotracheal intubation

    Time frame: At intubation

    the proportion of patients with successful first-pass orotracheal intubation

Secondary outcomes

  1. Complications related to intubation

    Time frame: 1 hour after 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

Other outcomes

  1. Lowest SpO2 up to 24 hours after intubation

    Time frame: up to 24 hours after intubation

    Assessment of the value of the lowest SpO2

  2. Highest positive end expiratory pressure (PEEP) up to 24 hours after intubation

    Time frame: up to 24 hours after intubation

    Assessment of the value of the highest PEEP

  3. Highest fraction of inspired oxygen (FiO2) up to 24 hours after intubation

    Time frame: up to 24 hours after intubation

    Assessment of the value of the highest FiO2

  4. lowest SpO2 < 90%

    Time frame: during intubation

    incidence of lowest SpO2 less than 90% from induction to 2 minutes after intubation

  5. Change in SpO2

    Time frame: during intubation

    Change in SpO2 from SpO2 at induction to lowest SpO2

  6. desaturation

    Time frame: during intubation

    desaturation, defined as a change in SpO2 of more than 3% from induction to 2 minutes after intubation

  7. Cormack Lehane

    Time frame: during intubation

    Cormack-Lehane grade of glottic view

  8. difficulty of intubation

    Time frame: during intubation

    operator-assessed difficulty of intubation

  9. additional airway equipment or second operator

    Time frame: during intubation

    need for additional airway equipment or a second operator

  10. laryngoscopy attempts

    Time frame: during intubation

    number of laryngoscopy attempts

  11. Lowest SpO2 from 0-1 hour post intubation

    Time frame: up to 1 hour after intubation

    Assessment of the value of the lowest SpO2 from 0-1 hours after intubation

  12. Highest FiO2 from 0-1 hour post intubation

    Time frame: up to 1 hour after intubation

    Assessment of the value of the highest FiO2 from 0-1 hours after intubation

  13. Highest PEEP from 0-1 hour post intubation

    Time frame: up to 1 hour after intubation

    Assessment of the value of the highest PEEP from 0-1 hours after intubation

  14. Lowest SpO2 from 1-6 hours post intubation

    Time frame: From 1 to 6 hours after intubation

    Assessment of the value of the lowest SpO2 from 1-6 hours after intubation

  15. Highest FiO2 from 1-6 hours post intubation

    Time frame: From 1 to 6 hours after intubation

    Assessment of the value of the highest FiO2 from 1-6 hours after intubation

  16. Highest PEEP from 1-6 hours post intubation

    Time frame: From 1 to 6 hours after intubation

    Assessment of the value of the highest PEEP from 1-6 hours after intubation

  17. new infiltrate

    Time frame: Up to 48 hours after intubation

    new infiltrate on chest imaging in the 48 hours after intubation

  18. new pneumothorax

    Time frame: Up to 24 hours after intubation

    new pneumothorax on chest imaging in the 24 hours after intubation

  19. new pneumomediastinum

    Time frame: Up to 24 hours after intubation

    new pneumomediastinum on chest imaging in the 24 hours after intubation

  20. Intensive care unit (ICU) length of stay

    Time frame: Up to 90 days after intubation

    ICU length of stay

  21. ICU-free days

    Time frame: Up to 90 days after intubation

    ICU-free days

  22. invasive ventilator-free days

    Time frame: Up to 90 days after intubation

    invasive ventilator-free days

  23. mortality rate on day 28

    Time frame: Up to 28 days after intubation

    mortality rate on day 28

  24. In hospital mortality

    Time frame: Up to 90 days after intubation

    in hospital mortality

  25. mortality rate on day 90

    Time frame: Up to 90 days after intubation

    mortality rate on day 90

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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"

Acronym: STYLETO

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 6, 2019
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.