Tracheal intubation in the intensive care unit (ICU) is associated with high incidence of difficult intubation and complications. Videolaryngoscopes (VLs) devices have been proposed to improve airway management, and the use of VLs are recommended as first-line or after a first-attempt failure using direct laryngoscopy in ICU airway management algorithms. Although until relatively few years ago there were doubts about whether videolaryngoscopes had advantages over direct laryngoscopy for endotracheal intubation (ETI) in critically ill patients, two recent studies (DEVICE (1), INTUBATE (2)), and a Cochrane review (3) have confirmed that videolaryn should be used?, and what is the best blade? . There are two types of blades commonly used with videolaryngoscopes: the "Macintosh" blade with a slight curvature, and hyperangulated blades. The "Macintosh" blades have a lower angle of vision, but they have the advantage of being similar to the blades commonly used in direct laryngoscopy, making them easy to use for the person performing the ETI. Hyperangulated blades have a greater angle of vision, improving glottic visualization, especially in patients with an anterior glottis. However, the need to overcome this angulation could potentially hinder the passage of the endotracheal tube to the vocal cords. It is unknown if either blade has any advantage for intubating critically ill patients.
The purpose of this prospective multicenter randomized study is to compare successful intubation on the first attempt with the Macintosh videolaryngoscope vs the hyperangulated videolaryngoscope during tracheal intubation in ICU patients.The hypothesis of the study is that tracheal intubation using the hyperangulated videolaryngoscope will improve the frequency of successful intubation on the first attempt in ICU patients requiring intubation in the intensive care unit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
1,036
For patients assigned to the Hyperangulated videolaryngoscope Group, the operator will use a Hyperangulated video laryngoscope on the first laryngoscopy attempt.
For patients assigned to the Macintosh videolaryngoscope Group, the operator will use a Hyperangulated video laryngoscope on the first laryngoscopy attempt.
University Clinical Hospital of Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
RECRUITINGComplexo Hospitalario Universitario de A Coruña
A Coruña, Spain
RECRUITINGHospital General de Albacete
Albacete, Spain
NOT_YET_RECRUITINGHospital de la Santa Creu i Sant Pau, Barcelona
Barcelona, Spain
Difference in the first attempt intubation success rate (percentage)
The primary outcome is defined as placement of an endotracheal tube in the trachea with a single insertion of a videolaryngoscope blade into the mouth and either a single insertion of an endotracheal tube into the mouth or a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube over the bougie into the mouth.
Time frame: During intubation (minutes)
Difference in the overall success rate
To compare the difference overall success rate (percentage) with the two (hyperangulated vs Macintosh blades) videolaryngoscopes
Time frame: During intubation (minutes)
Number of intubation attempts
To compare number of intubations attempts with the two (hyperangulated vs Macintosh blades) videolaryngoscopes
Time frame: During intubation (minutes)
Modified Cormack-Lehane grade of glottic view
To compare Cormack-Lehane grade of glottic view with the two (hyperangulated vs Macintosh blades) videolaryngoscopes. Modified Cormack-Lehane grade of glottic view is defined as: Grade I: full view of the glottis Grade IIa: partial view of the glottis Grade IIb: arytenoid or posterior part of the vocal cords just visible Grade III: only epiglottis visible Grade IV: neither glottis nor epiglottis visible Cormack-Lehane grade of glottic view
Time frame: During intubation (minutes)
Diference in the incidence of "easy intubation"
To compare the difference in the incidence of "easy intubation" defined as a patient with Cormack-Lehane I-II glottic view and intubation on the first attempt.
Time frame: During intubation (minutes)
Duration of tracheal intubation
To compare the interval (in seconds) between the first insertion of a videolaryngoscope blade into the mouth and the final placement of an endotracheal tube in the trachea.
Time frame: Duration of procedure (minutes)
Reason for unsuccessful intubation on the first attempt
Causes of unsuccessful intubation on the first attempt: * Limited visibility of the larynx * Difficulty in properly inserting the endotracheal tube * Challenges in cannulating the trachea with a bougie * Interruption of the attempt due to changes in the patient's condition (such as deteriorating hypoxemia, hypotension, bradycardia, vomiting, or bleeding) * Technical malfunctions with the laryngoscope equipment (such as battery issues, light source malfunction, camera problems, or screen issues) * Other factors
Time frame: Duration of procedure (minutes)
Number of videolaryngoscopy attempts
To compare the number of videolaryngoscope attempts neccesary to successfull tracheal intubation
Time frame: Duration of procedure (minutes)
Number of attempts to cannulate the trachea with a bougie or an endotracheal tube
To compare the number of attempts to cannulate the trachea with a bougie or an endotracheal tube
Time frame: Duration of procedure (minutes)
Operator-assessed difficulty of intubation
To compare operator-assessed subjective difficulty of intubation: * without difficulty * mild difficulty * moderate difficulty * severe difficulty
Time frame: Duration of procedure (minutes)
Need for additional airway equipment
Airway equipment: bougie, stylet, other videolaryngoscope, others
Time frame: Duration of procedure (minutes)
Need to change the device for intubation
Need to replace by another videolaryngoscope, a different angled blade, requirement for a fiberoptic bronchoscope...).
Time frame: Duration of procedure (minutes)
Complications of tracheal intubation
Complications: * Hypoxemia (lowest oxygen saturation measured by pulse oximetry 80%-90%) * Severe hypoxemia (lowest oxygen saturation measured by pulse oximetry \< 80%) * Hypotension (systolic blood pressure between 80-65 mm Hg) * Severe hypotension (systolic blood pressure \< 65 mm Hg) * Pulmonary aspiration * Esophageal intubation * Dental injuries * Airway injuries * Others
Time frame: Duration of procedure (minutes)
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Hospital Universitario de Cáceres
Cáceres, Spain
NOT_YET_RECRUITINGHospital de Denia
Denia, Spain
NOT_YET_RECRUITINGHospital General Universitario de Eche
Elche, Spain
NOT_YET_RECRUITINGHospital Universitario de Cabueñes, Gijón
Gijón, Spain
NOT_YET_RECRUITINGHospital Virgen de las Nieves, Granada
Granada, Spain
NOT_YET_RECRUITINGHospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Spain
NOT_YET_RECRUITING...and 19 more locations