Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone

Critically Ill Clinical Trial

— STYLETO  

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04079387
• Other study ID #: 7803
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: June 15, 2020

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1040
• Est. completion date: June 15, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Intubation Complication

Intervention

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°
• ENDOTRACHEAL TUBE ALONE
intubating the trachea with an endotracheal tube alone

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Montpellier, Saint Eloi	Montpellier	Languedoc-Roussillon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lowest SpO2 up to 24 hours after intubation	Assessment of the value of the lowest SpO2	up to 24 hours after intubation
Other	Highest positive end expiratory pressure (PEEP) up to 24 hours after intubation	Assessment of the value of the highest PEEP	up to 24 hours after intubation
Other	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
Other	lowest SpO2 < 90%	incidence of lowest SpO2 less than 90% from induction to 2 minutes after intubation	during intubation
Other	Change in SpO2	Change in SpO2 from SpO2 at induction to lowest SpO2	during intubation
Other	desaturation	desaturation, defined as a change in SpO2 of more than 3% from induction to 2 minutes after intubation	during intubation
Other	Cormack Lehane	Cormack-Lehane grade of glottic view	during intubation
Other	difficulty of intubation	operator-assessed difficulty of intubation	during intubation
Other	additional airway equipment or second operator	need for additional airway equipment or a second operator	during intubation
Other	laryngoscopy attempts	number of laryngoscopy attempts	during intubation
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	new infiltrate	new infiltrate on chest imaging in the 48 hours after intubation	Up to 48 hours after intubation
Other	new pneumothorax	new pneumothorax on chest imaging in the 24 hours after intubation	Up to 24 hours after intubation
Other	new pneumomediastinum	new pneumomediastinum on chest imaging in the 24 hours after intubation	Up to 24 hours after intubation
Other	Intensive care unit (ICU) length of stay	ICU length of stay	Up to 90 days after intubation
Other	ICU-free days	ICU-free days	Up to 90 days after intubation
Other	invasive ventilator-free days	invasive ventilator-free days	Up to 90 days after intubation
Other	mortality rate on day 28	mortality rate on day 28	Up to 28 days after intubation
Other	In hospital mortality	in hospital mortality	Up to 90 days after intubation
Other	mortality rate on day 90	mortality rate on day 90	Up to 90 days after intubation
Primary	Number of patients with successful first-pass orotracheal intubation	the proportion of patients with successful first-pass orotracheal intubation	At intubation
Secondary	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