Centre Hospitalier Universitaire Montpellier, Saint Eloi
Montpellier, Languedoc-Roussillon, 34295, France
NCT Number: NCT04079387
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
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All sexes
Interventional
Not applicable
Montpellier, Languedoc-Roussillon, 34295, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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°
intubating the trachea with an endotracheal tube alone
Time frame: At intubation
the proportion of patients with successful first-pass orotracheal 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
Time frame: up to 24 hours after intubation
Assessment of the value of the lowest SpO2
Time frame: up to 24 hours after intubation
Assessment of the value of the highest PEEP
Time frame: up to 24 hours after intubation
Assessment of the value of the highest FiO2
Time frame: during intubation
incidence of lowest SpO2 less than 90% from induction to 2 minutes after intubation
Time frame: during intubation
Change in SpO2 from SpO2 at induction to lowest SpO2
Time frame: during intubation
desaturation, defined as a change in SpO2 of more than 3% from induction to 2 minutes after intubation
Time frame: during intubation
Cormack-Lehane grade of glottic view
Time frame: during intubation
operator-assessed difficulty of intubation
Time frame: during intubation
need for additional airway equipment or a second operator
Time frame: during intubation
number of laryngoscopy attempts
Time frame: up to 1 hour after intubation
Assessment of the value of the lowest SpO2 from 0-1 hours after intubation
Time frame: up to 1 hour after intubation
Assessment of the value of the highest FiO2 from 0-1 hours after intubation
Time frame: up to 1 hour after intubation
Assessment of the value of the highest PEEP from 0-1 hours after intubation
Time frame: From 1 to 6 hours after intubation
Assessment of the value of the lowest SpO2 from 1-6 hours after intubation
Time frame: From 1 to 6 hours after intubation
Assessment of the value of the highest FiO2 from 1-6 hours after intubation
Time frame: From 1 to 6 hours after intubation
Assessment of the value of the highest PEEP from 1-6 hours after intubation
Time frame: Up to 48 hours after intubation
new infiltrate on chest imaging in the 48 hours after intubation
Time frame: Up to 24 hours after intubation
new pneumothorax on chest imaging in the 24 hours after intubation
Time frame: Up to 24 hours after intubation
new pneumomediastinum on chest imaging in the 24 hours after intubation
Time frame: Up to 90 days after intubation
ICU length of stay
Time frame: Up to 90 days after intubation
ICU-free days
Time frame: Up to 90 days after intubation
invasive ventilator-free days
Time frame: Up to 28 days after intubation
mortality rate on day 28
Time frame: Up to 90 days after intubation
in hospital mortality
Time frame: Up to 90 days after intubation
mortality rate on day 90
University Hospital, Montpellier
Other
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
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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.
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