Intubation
Conditions
Keywords
intubation, difficult airway, videolaryngoscope
Brief summary
Patients with anticipated difficult airway are recommended to be managed with an awake tracheal intubation. Initially fibreoptic bronchoscopy was considered the gold standard, but in the last decade videolaryngoscopes have been demonstrated to be an efficacy alternative technique. Recently, a systematic review and meta-analysis was published investigating the efficacy and safety of videolaryngoscopy compared with fibreoptic bronchoscopy for awake tracheal intubation. Eight prospective, randomized studies were included, with different videolaryngoscopes (C-MAC, GlideScope, Pentax AWS, McGraft, and Bullard). However, a direct comparison of two different videolaryngoscopes for awake tracheal intubation in patients with anticipated difficult airway has not been performed.
Detailed description
This is a clinical prospective randomized-controlled trial. The aim of this study is to compare two different devices (C-MAC videolaryngoscope and Airtraq videolaryngoscope) for awake tracheal intubation in patients with difficult airways scheduled for surgery. The primary endpoint will be to compare first-attempt intubation success rate between the two videolaryngoscopes. Secondary outcomes will be to compare: difference in the overall success rate, number of intubation attempts, Cormack-Lehane grade of glottic view, incidence of complications related to intubation, difficulty experienced by the operator, patient's tolerability of the procedure.
Interventions
DEVICEC-MAC videolaryngoscope
Patients with anticipated difficult airway will be awake intubated with a C-MAC videolaryngoscopy
DEVICEAirtraq videolaryngoscope.
Patients with anticipated difficult airway will be awake intubated with a Airtraq videolaryngoscopy
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 awake intubation under local anaesthesia and conscious sedation for general anesthesia. * 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 success rate (percentage) of different awake videolaryngoscope techniques for tracheal intubation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of intubation attempts | during intubation | To compare number of intubations attempts with the two awake videolaryngoscope techniques. |
| Cormack-Lehane grade of glottic view | during intubation | To compare Cormack-Lehane grade of glottic view with the two awake videolaryngoscope techniques for tracheal intubation. |
| Difference in the incidence of complications related to intubation (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 awake videolaryngoscope techniques. 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 esophageal intubation pulmonary aspiration, dental injuries Oral-pharynx and larynx traumatism |
| Difference in the overall success rate (percentage) | during intubation | To compare the difference overall success rate (percentage) with the two awake videolaryngoscope techniques for tracheal intubation. |
| Degree of subjective patient's tolerability of the procedure | during intubation | Operator-assessed subjective patient's tolerance of the procedure by means of a special analogue numerical scale from 0 to 10, where 0=very good subjective tolerance and 10=very bad subjective tolerance |
| Degree of patient's confort of the procedure | 24 hours after intubation | During the postoperative visit on the following day (24 hours after intubation), patient will be asked to rate their confort during the procedure by means of a special analogue numerical scale from 0 to 10, where 0=very good tolerance and 10=worst possible discomfort |
| Degree of subjective difficulty experienced by the operator | 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 |
Countries
Spain
Outcome results
None listed