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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENDOTRACHEAL TUBE + STYLET | Experimental | 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 | Active Comparator | The control group consists in intubating the trachea with an endotracheal tube alone (i.e, without stylet). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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° |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Montpellier, Saint Eloi | Montpellier | Languedoc-Roussillon | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34032882 | Result | 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. | |
| 33033014 |
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12 months after the main publication
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.
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ENDOTRACHEAL TUBE ALONE | Device | intubating the trachea with an endotracheal tube alone |
|
| 1 hour 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 |
| Derived |
| 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. |