Anesthesia Intubation Complication, Difficult Intubation
Conditions
Keywords
videolaryngoscopy, tracheal intubation
Brief summary
Cleverscope is a new medical device that transform a laryngoscope into a videolaryngoscope. previous its commercialization we evaluate its safety and efficacy.
Detailed description
the investigators develope two part study. part I: the investigators collect data of 50 patients prospectively programed for general anesthesia and tracheal intubation without predictors of difficult airways. this patients were intubated with cleverscope, the investigators register best cormack-lehane (glottic vision) obtained with Cleverscope and best cormack obtained with direct laryngoscopy. the investigators register intubation succes rate and any complications during its use and after extubation. part II: after confirm safety and efficacy in patients without difficult airways (part I) the investigators use Cleverscope for the same pourpose on difficult airways patients. collecting same data . the investigators compare cormack-lehane in this patients with Cleverscope and commercial Videolaryngoscope C-MAC.
Interventions
DEVICECleverscope
the device is used in patients without difficult airways predictors
DEVICELaryngoscope / Videolaryngoscope C-MAC® Storz
the device is used in patients with difficult airways predictors
Sponsors
FIPSE
Hospital General Universitario de Valencia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
part 1 its single group of participants(50 patients without difficult airways predictors). this group receives direct laringoscopy with common laryngoscope (L) during the initial phase of the trial, followed by videolaryngoscope (VL) Cleverscope (used for intubation) during a later phase. part 2 of the study its two-by-two cross-over assignment involves two groups of participants(84 patients with difficult airways predictors). One group receives VL with C-MAC during the initial phase of the trial, followed by Cleverscope for intubation during a later phase. The other group receives VL with Cleverscope during the initial phase, followed by C-MAC VL used for intubation. So during the part 2 trial, participants cross over to the other videolaringoscopy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* part 1: Scheduled Patients for any kind of surgery with general anesthesia with tracheal intubation without predictors of difficult intubation : 1. Arne Test \< 10 2. cervical circunference / tyromental distance \< 4. * part 2: Scheduled Patients for any kind of surgery with general anesthesia with tracheal intubation with predictors of difficult intubation : 1. Arne Test \> 10 2. cervical circunference / tyromental distance \> 4.
Exclusion criteria
* no mouth openning \>2cm * required use of awake fiberscope por tracheal intubation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cormack-Lehane Glotic visualization scale (I(complete view, easy to intubate)-IV(no view, imposible to intubate) | intraoperative | degree of glotis visualization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall success intubation rate with same device | intraoperative | it could include more attempts |
| time to success | intraoperative | time wasted from device inserted into mouth to inflate tracheal tube |
| complications rate | intraoperative | register complications during intubation or due device usage. like hemorrage, mucosal laceration, |
| First attempt intubation success rate | intraoperative | the rate of traqueal tube pass through vocal cords at first attemps. |
Countries
Spain
Contacts
Primary ContactLucas Rovira, PhD
Outcome results
None listed