A new medical device that Converts a LaryngoscopE into a low-cost VideolaryngoscopE Reusable. (C.LE.VE.R.scope)

L. Rovira, I. Leon , J. Hernandez, L. Alcover,, J. Moreno, J. De Andres 
Hospital General Universitario de Valencia - Valencia (Spain)

Background: Direct laryngoscopy (DL) is still the gold standard for tracheal intubation. Video laryngoscopy (VL) decrease Cormack enhancing glottic vision, it is used as rescue device when DL fails or when a patient has difficult airway predictors.Then, why is not VL first-line device for tracheal intubation? Price is the problem.VL are expensive, they are not in every place, and each model has different way of use, different from DL. CLEVERscope(CL) is a new medical device that fits on Macintosh and McCoy blades, and convert them into a video laryngoscope. It produces the most economic VL in the market, very simple to mount–unmount, used like DL. Previous its commercialization we test in humans its safety and efficacy.
Material and Methods: After ethics committee and regulatory agency approval we start observational (PHASE I) study of 50 patients programmed for surgery with general anesthesia without difficult airway predictors. All patients signed consent. After induction we first do a DL with a Macintosh nº4 blade, and then we perform tracheal intubation with CL mounted on the same blade, we registered Cormack of both attempts, time of CL procedure,success rate (first attempt and global), and any complications associated with CL use (blood, teeth, mucosal or glottic lesions) both intra and postoperative.We interview patients at PACU looking for complications (pain, dysphonia). CLEVERscope has different parts, the gadget that anchors the laryngoscope blade(Utility Model certificate 201630976 and international extension PCT/ES2017/070540), microcamera and a 7” monitor that can be replaced by an Android smartphone.
Results and Discussion: Partial sample collected(15/50) shows that Cormack I with CL was 90%(36/40) but only 57,5% (23/40) with DL. CL reduce Cormack 1.45 degrees when DL shows Cormack > I. 
All patients could be intubated with CL, 95% at first attempt, only 5%(2/40) need a second attempt (one preforming tracheal tube with a stylet and another increasing blade number). Mean time for tracheal intubation was 41.1 seg. None of 40 patients suffered immediate complications during CL use. At PACU interview only two patients report a mild sore throat (VAS<4).

Conclusion: This study shows that CLEVERscope is a safe medical device without serious complications, being an effective Videolaryngoscope that increase glottic vision over Direct laryngoscopy (at least reduce one Cormack degree), with a high intubation success rate and reduced intubation time.

04 / A new medical device that Converts a LaryngoscopE into a low-cost VideolaryngoscopE Reusable. (C.LE.VE.R.scope)