Safety and Efficacy of Cleverscope. A New Medical Device for Tracheal Intubation

Study Overview
=================
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.

Official Title
-----------------
Safety and Efficacy Assessment of a New Tracheal Intubation Device Cleverscope. Success Rate of Cleverscope in Patients With Suspected Difficult Airway.

Conditions
-----------------
Difficult Intubation, Anesthesia Intubation Complication

Intervention / Treatment
-----------------
* Device: Cleverscope
* Device: Laryngoscope / Videolaryngoscope C-MAC® Storz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: part 1: Scheduled Patients for any kind of surgery with general anesthesia with tracheal intubation without predictors of difficult intubation : Arne Test < 10 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 : Arne Test > 10 cervical circunference / tyromental distance > 4. Exclusion Criteria: no mouth openning >2cm required use of awake fiberscope por tracheal intubation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cleverscope<br>Cleverscope is a new videolaryngoscope used for tracheal intubation. in this group we use this device to intubate participants. | Device: Cleverscope<br>* the device is used in patients without difficult airways predictors<br>|
| Active Comparator: Laryngoscope / Videolaryngoscope C-MAC® Storz<br>in this group we use a standart comercial device for intubation (laryngoscope or C-MAC) to intubate participants | Device: Laryngoscope / Videolaryngoscope C-MAC® Storz<br>* the device is used in patients with difficult airways predictors<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cormack-Lehane Glotic visualization scale (I(complete view, easy to intubate)-IV(no view, imposible to intubate) | degree of glotis visualization | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First attempt intubation success rate | the rate of traqueal tube pass through vocal cords at first attemps. | intraoperative | 
| overall success intubation rate with same device | it could include more attempts | intraoperative | 
| time to success | time wasted from device inserted into mouth to inflate tracheal tube | intraoperative | 
| complications rate | register complications during intubation or due device usage. like hemorrage, mucosal laceration, | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
videolaryngoscopy, tracheal intubation