Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone

Study Overview
=================
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

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.

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

Conditions
-----------------
Intubation Complication, Critically Ill

Intervention / Treatment
-----------------
* Device: ENDOTRACHEAL TUBE + STYLET
* Device: ENDOTRACHEAL TUBE ALONE


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENDOTRACHEAL TUBE + STYLET<br>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<br>* 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°<br>|
| Active Comparator: ENDOTRACHEAL TUBE ALONE<br>The control group consists in intubating the trachea with an endotracheal tube alone (i.e, without stylet). | Device: ENDOTRACHEAL TUBE ALONE<br>* intubating the trachea with an endotracheal tube alone<br>|

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 |