Acute Respiratory Failure, Intubation, Intubation Complication, Intubation; Difficult or Failed, Videolaryngoscopy
Conditions
Keywords
videolaryngoscopy, tracheal intubation, complication
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHyperangulated blade videolaryngoscope
For patients assigned to the Hyperangulated videolaryngoscope Group, the operator will use a Hyperangulated video laryngoscope on the first laryngoscopy attempt.
DEVICEMacintosh blade videolaryngoscope
For patients assigned to the Macintosh videolaryngoscope Group, the operator will use a Hyperangulated video laryngoscope on the first laryngoscopy attempt.
Sponsors
Hospital Clinico Universitario de Santiago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older. * Admitted to an Intensive Care Unit. * Need for tracheal intubation during the stay in the ICU. * The device to be used for intubation is a videolaryngoscope
Exclusion criteria
* Pregnancy or lactation. * Emergent tracheal intubation that does not allow for the randomization of the procedure. * Need for tracheal intubation with a device other than the videolaryngoscope (fiberoptic bronchoscope, direct laryngoscopy, tracheostomy, etc.). * Tracheal intubation performed outside the ICU (Emergency Department, Hospital ward, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the first attempt intubation success rate (percentage) | During intubation (minutes) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of intubation attempts | During intubation (minutes) | To compare number of intubations attempts with the two (hyperangulated vs Macintosh blades) videolaryngoscopes |
| Modified Cormack-Lehane grade of glottic view | During intubation (minutes) | 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 |
| Diference in the incidence of easy intubation | During intubation (minutes) | 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. |
| Duration of tracheal intubation | Duration of procedure (minutes) | 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. |
| Reason for unsuccessful intubation on the first attempt | Duration of procedure (minutes) | 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 |
| Difference in the overall success rate | During intubation (minutes) | To compare the difference overall success rate (percentage) with the two (hyperangulated vs Macintosh blades) videolaryngoscopes |
| Number of attempts to cannulate the trachea with a bougie or an endotracheal tube | Duration of procedure (minutes) | To compare the number of attempts to cannulate the trachea with a bougie or an endotracheal tube |
| Operator-assessed difficulty of intubation | Duration of procedure (minutes) | To compare operator-assessed subjective difficulty of intubation: * without difficulty * mild difficulty * moderate difficulty * severe difficulty |
| Need for additional airway equipment | Duration of procedure (minutes) | Airway equipment: bougie, stylet, other videolaryngoscope, others |
| Need to change the device for intubation | Duration of procedure (minutes) | Need to replace by another videolaryngoscope, a different angled blade, requirement for a fiberoptic bronchoscope...). |
| Complications of tracheal intubation | Duration of procedure (minutes) | 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 |
| Number of videolaryngoscopy attempts | Duration of procedure (minutes) | To compare the number of videolaryngoscope attempts neccesary to successfull tracheal intubation |
Countries
Spain
Contacts
Primary ContactManuel Taboada, Ph.D.
Backup ContactManuel Taboada
Outcome results
None listed