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

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

Cleverscope is a new medical device that transform a laryngoscope into a videolaryngoscope. previous its commercialization we evaluate its safety and efficacy.

Study Overview

• Status: Recruiting
• Conditions: Difficult Intubation; Anesthesia Intubation Complication
• Intervention / Treatment: Device: Cleverscope; Device: Laryngoscope / Videolaryngoscope C-MAC® Storz

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 Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucas Rovira, PhD; Phone Number: +34659276476; Email: lucasrovira@gmail.com

Study Locations

• Spain
  • Valencia
    • La Pobla De Vallbona, Valencia, Spain, 46185
      • Recruiting
      • Lucas Rovira
      • Contact: Lucas Rovira, PhD; Phone Number: +34659276476; Email: lucasrovira@gmail.com
      • Principal Investigator: Lucas Rovira, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Hospital General Universitario de Valencia
• Collaborators: FIPSE

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 31, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: tracheal intubation; videolaryngoscopy
• Other Study ID Numbers: Rov-Clever-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No