Intubation; Difficult or Failed
Conditions
Brief summary
The present randomized clinical trial wants to compare the efficacy and safety of UED-A videolaryngoscope to Glidescope Titanium for routinely tracheal intubation in 60 adults, in terms of successful rate, no. attempts and manoeuvre duration.
Interventions
DEVICEUED-A Videolaryngoscopy
Tracheal Intubation with UED-A videolaryngoscope
DEVICEGlidescope Videolaryngoscopy
Tracheal Intubation with Glidescope Titanium videolaryngoscope
Sponsors
Campus Bio-Medico University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients candidates for general anesthesia in elective general surgery * Age over 18 years * American Society of Anesthesiologists (ASA) physical status I-III.
Exclusion criteria
* Refusal to sign informed consent * Paediatric population * ASA physical status IV * Emergency tracheal intubation * Independent Predictors of difficult Videolaryngoscopy (Neck extension \< 80°, macroglossia, interincisor distance \< 3 cm, anatomical alterations of the neck, cardiac surgery, ear-nose-throat surgery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cormack-Lehane grade | 15 minutes | Cormack-Lehane grade observed at videolaryngoscopy Grade 1: Full view of glottis Grade 2: Partial view of glottis Grade 3: Only epiglottis seen, none of glottis seen Grade 4: Neither glottis nor epiglottis seen |
| Tracheal intubation rate | 30 minutes | Successful tracheal intubation rate |
| Number of attempts | 30 minutes | Number of attempts for a successful tracheal intubation |
| Total time of intubation | 15 minutes | Time needed to perform a tracheal intubation from the insertion of the video laryngoscope into the patient mouth |
| Time to glottis visualization | 15 minutes | Time needed to visualize the glottis from the insertion of the video laryngoscope into the patient mouth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of of post-laryngoscopy side effects | 24 hours | Rate of of post-laryngoscopy side effects (bleeding, postoperative sore throat and/or dysphonia) |
| Rate of Desaturation | 15 minutes | Rate of Desaturation (spO2 \< 93%) during tracheal intubation attempts |
| Satisfaction Scale | 30 minutes | Clinicians Satisfaction with the use of the videolaryngoscope, expressed by a 0-10 numeric rating scale (0 = the worst videolaryngoscopy ever performed; 10 = the best videolaryngoscopy ever performed) |
| Rate of External laryngeal pressure | 15 minutes | Rate of external laryngeal pressure during laryngoscopy |
Countries
Italy
Outcome results
None listed