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

• ClinicalTrials.gov Identifier: NCT04079387
• Recruitment Status: Active, not recruiting
• First Posted: September 6, 2019
• Last Update Posted: March 20, 2020
• Sponsor: University Hospital, Montpellier
• Information provided by (Responsible Party): University Hospital, Montpellier

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Intubation Complication; Critically Ill	Device: ENDOTRACHEAL TUBE + STYLET; Device: ENDOTRACHEAL TUBE ALONE	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1040 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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"
• Actual Study Start Date: October 1, 2019
• Actual Primary Completion Date: March 16, 2020
• Estimated Study Completion Date: October 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

France

Centre Hospitalier Universitaire Montpellier, Saint Eloi

Montpellier, Languedoc-Roussillon, France, 34295

Sponsors and Collaborators

University Hospital, Montpellier

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT04079387
• Other Study ID Numbers: 7803
• First Posted: September 6, 2019
• Last Update Posted: March 20, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol
• Time Frame: 12 months after the main publication
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Critical Illness; Disease Attributes; Pathologic Processes