Although VLs improve glottic visualization, on many occasions it may not be accompanied by intubation at the first attempt, because the endotracheal tube has to pass a sharp angle to enter the trachea. To avoid this limitation, a new flexible tip bougie is designed to flexibly navigate the distal tip and help facilitate precise insertion of the endotracheal tube in the trachea. The flexible tip bougie has an integrated slider along the surface which moves the tip anterior and posterior while the pre-curved distal portion of shaft allows the angulation to provide anterior flexion. This new flexible tip bougie could be used as a rescue when first intubation failure using the videolaryngoscopy, or as a first option to improve the percentage of patients intubated at the first attempt.
18 years and older
Patients with anticipated difficult airway requiring intubation under with a videolaryngoscopy
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.
Pregnancy
age <18 years
refusal of the patient
patient's respiratory failure
Parallel
Endotracheal Tube with Stylet
DevicePatients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with an endotracheal tube + stylet.
Flexible Tip Bougie
DevicePatients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie.
Difference in the first attempt intubation success rate (percentage)
To compare the difference in the first attempt intubation success rate (percentage) with the two differents devices compared.
Difference in the overall intubation success rate (percentage)
To compare the difference overall intubation success rate (percentage) with the two differents devices compared.
Difference in the incidence of complications (percentage)
To compare the difference in complications (percentage) with the two different devices compared: Hypoxemia (SpO2) \< 90 %, Hypoxemia severe (SpO2) \< 80 %, Hypotension defined as systolic blood pressure less than 80 mm Hg, Severe hypotension defined as systolic blood pressure less than 65 mm Hg, Cardiac arrest, death during intubation, Moderate or difficult intubation, oesophageal intubation, pulmonary aspiration, dental injuries.
Difficulty of intubation
Operator-assessed subjective difficulty of intubation by means of a special analogue numerical scale from 0 to 10, where 0=no subjective difficulty and 10=maximal subjective difficulty
Modified Cormack-Lehane grade of glottic view
Modified Cormack-Lehane grade of glottic view: I: full view of the glottis IIa: partial view of the glottis IIb: arytenoid or posterior part of the vocal cords just visible III: only epiglottis visible IV: neither glottis nor epiglottis visible
Click on the lead sponsor to view all of their trials.
