STYLETO: Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone
Study Details
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 |
|---|---|---|
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N/A |
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
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
- Number of patients with successful first-pass orotracheal intubation [At intubation]
the proportion of patients with successful first-pass orotracheal intubation
Secondary Outcome Measures
- Complications related to intubation [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
- Lowest SpO2 up to 24 hours after intubation [up to 24 hours after intubation]
Assessment of the value of the lowest SpO2
- Highest positive end expiratory pressure (PEEP) up to 24 hours after intubation [up to 24 hours after intubation]
Assessment of the value of the highest PEEP
- Highest fraction of inspired oxygen (FiO2) up to 24 hours after intubation [up to 24 hours after intubation]
Assessment of the value of the highest FiO2
- lowest SpO2 < 90% [during intubation]
incidence of lowest SpO2 less than 90% from induction to 2 minutes after intubation
- Change in SpO2 [during intubation]
Change in SpO2 from SpO2 at induction to lowest SpO2
- desaturation [during intubation]
desaturation, defined as a change in SpO2 of more than 3% from induction to 2 minutes after intubation
- Cormack Lehane [during intubation]
Cormack-Lehane grade of glottic view
- difficulty of intubation [during intubation]
operator-assessed difficulty of intubation
- additional airway equipment or second operator [during intubation]
need for additional airway equipment or a second operator
- laryngoscopy attempts [during intubation]
number of laryngoscopy attempts
- Lowest SpO2 from 0-1 hour post intubation [up to 1 hour after intubation]
Assessment of the value of the lowest SpO2 from 0-1 hours after intubation
- Highest FiO2 from 0-1 hour post intubation [up to 1 hour after intubation]
Assessment of the value of the highest FiO2 from 0-1 hours after intubation
- Highest PEEP from 0-1 hour post intubation [up to 1 hour after intubation]
Assessment of the value of the highest PEEP from 0-1 hours after intubation
- Lowest SpO2 from 1-6 hours post intubation [From 1 to 6 hours after intubation]
Assessment of the value of the lowest SpO2 from 1-6 hours after intubation
- Highest FiO2 from 1-6 hours post intubation [From 1 to 6 hours after intubation]
Assessment of the value of the highest FiO2 from 1-6 hours after intubation
- Highest PEEP from 1-6 hours post intubation [From 1 to 6 hours after intubation]
Assessment of the value of the highest PEEP from 1-6 hours after intubation
- new infiltrate [Up to 48 hours after intubation]
new infiltrate on chest imaging in the 48 hours after intubation
- new pneumothorax [Up to 24 hours after intubation]
new pneumothorax on chest imaging in the 24 hours after intubation
- new pneumomediastinum [Up to 24 hours after intubation]
new pneumomediastinum on chest imaging in the 24 hours after intubation
- Intensive care unit (ICU) length of stay [Up to 90 days after intubation]
ICU length of stay
- ICU-free days [Up to 90 days after intubation]
ICU-free days
- invasive ventilator-free days [Up to 90 days after intubation]
invasive ventilator-free days
- mortality rate on day 28 [Up to 28 days after intubation]
mortality rate on day 28
- In hospital mortality [Up to 90 days after intubation]
in hospital mortality
- mortality rate on day 90 [Up to 90 days after intubation]
mortality rate on day 90
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients must be present in the intensive care unit (ICU) and require mechanical ventilation through an orotracheal tube.
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Adult (age ≥ 18 years)
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Subjects must be covered by public health insurance
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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:
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Refusal of study participation or to pursue the study by the patient
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Pregnancy or breastfeeding
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Absence of coverage by the French statutory healthcare insurance system
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protected person
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intubation in case of cardio circulatory arrest
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Previous intubation during the same ICU stay and already included in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Universitaire Montpellier, Saint Eloi | Montpellier | Languedoc-Roussillon | France | 34295 |
Sponsors and Collaborators
- University Hospital, Montpellier
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 7803