Clinical trial NCT04079387: Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone
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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Complication
Critically Ill
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 1040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of patients with successful first-pass orotracheal intubation
timeFrame: At intubation
Secondary outcomes:
measure: Complications related to intubation
timeFrame: 1 hour after intubation
Other outcomes:
measure: Lowest SpO2 up to 24 hours after intubation
timeFrame: up to 24 hours after intubation
measure: Highest positive end expiratory pressure (PEEP) up to 24 hours after intubation
timeFrame: up to 24 hours after intubation
measure: Highest fraction of inspired oxygen (FiO2) up to 24 hours after intubation
timeFrame: up to 24 hours after intubation
measure: lowest SpO2 < 90%
timeFrame: during intubation
measure: Change in SpO2
timeFrame: during intubation
measure: desaturation
timeFrame: during intubation
measure: Cormack Lehane
timeFrame: during intubation
measure: difficulty of intubation
timeFrame: during intubation
measure: additional airway equipment or second operator
timeFrame: during intubation
measure: laryngoscopy attempts
timeFrame: during intubation
measure: Lowest SpO2 from 0-1 hour post intubation
timeFrame: up to 1 hour after intubation
measure: Highest FiO2 from 0-1 hour post intubation
timeFrame: up to 1 hour after intubation
measure: Highest PEEP from 0-1 hour post intubation
timeFrame: up to 1 hour after intubation
measure: Lowest SpO2 from 1-6 hours post intubation
timeFrame: From 1 to 6 hours after intubation
measure: Highest FiO2 from 1-6 hours post intubation
timeFrame: From 1 to 6 hours after intubation
measure: Highest PEEP from 1-6 hours post intubation
timeFrame: From 1 to 6 hours after intubation
measure: new infiltrate
timeFrame: Up to 48 hours after intubation
measure: new pneumothorax
timeFrame: Up to 24 hours after intubation
measure: new pneumomediastinum
timeFrame: Up to 24 hours after intubation
measure: Intensive care unit (ICU) length of stay
timeFrame: Up to 90 days after intubation
measure: ICU-free days
timeFrame: Up to 90 days after intubation
measure: invasive ventilator-free days
timeFrame: Up to 90 days after intubation
measure: mortality rate on day 28
timeFrame: Up to 28 days after intubation
measure: In hospital mortality
timeFrame: Up to 90 days after intubation
measure: mortality rate on day 90
timeFrame: Up to 90 days after intubation
Locations:
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire Montpellier, Saint Eloi
state: Languedoc-Roussillon
Study officials:
References:
citation: 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.