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

Not Applicable

• Conditions: Anesthesia Intubation Complication; Difficult Intubation
• Interventions: Device: Cleverscope; Device: Laryngoscope / Videolaryngoscope C-MAC® Storz

• Registration Number: NCT03902704
• Lead Sponsor: Hospital General Universitario de Valencia

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.

Study Timeline

• Study First Submitted: 2019-03-31
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-04
• Study Start: 2019-10-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-13
• Last Update Posted: 2022-05-16
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cleverscope	Cleverscope	Cleverscope is a new videolaryngoscope used for tracheal intubation. in this group we use this device to intubate participants.
Laryngoscope / Videolaryngoscope C-MAC® Storz	Laryngoscope / Videolaryngoscope C-MAC® Storz	in this group we use a standart comercial device for intubation (laryngoscope or C-MAC) to intubate participants

Primary Outcome Measures

Name	Time	Method
Cormack-Lehane Glotic visualization scale (I(complete view, easy to intubate)-IV(no view, imposible to intubate)	intraoperative	degree of glotis visualization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lucas Rovira; 🇪🇸 La Pobla De Vallbona, Valencia, Spain