Intubation; Difficult or Failed
Conditions
Keywords
intubation, difficult airway, videolaryngoscope, operating room, Awake intubation
Brief summary
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.
Detailed description
The purpose of this prospective randomized study is to compare successful intubation on the first attempt with the new flexible tip bougie versus endotracheal tube with stylet during awake intubation with videolaryngoscopy in patients with anticipated difficult airway.
Interventions
Patients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with an endotracheal tube + stylet.
DEVICEFlexible Tip Bougie
Patients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie.
Sponsors
Hospital Clinico Universitario de Santiago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Pregnancy * age \<18 years * refusal of the patient * patient's respiratory failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the first attempt intubation success rate (percentage) | During intubation | To compare the difference in the first attempt intubation success rate (percentage) with the two differents devices compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the incidence of complications (percentage) | Participants will be followed from the beginning of the intervention to 30 minutes after the intervention | 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 | During 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 |
| Difference in the overall intubation success rate (percentage) | During intubation | To compare the difference overall intubation success rate (percentage) with the two differents devices compared. |
| Additional airway equipment | During intubation | Need for additional airway equipment |
| Number of intubation attempts | During intubation | Number of intubation attempts |
| Modified Cormack-Lehane grade of glottic view | During intubation | 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 |
Countries
Spain
Contacts
Primary ContactManuel Taboada Muñiz, Ph.D.
Backup ContactManuel Taboada Muñiz, Ph.D.
Outcome results
None listed