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

Difficult Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03902704
• Other study ID #: Rov-Clever-2017
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2022
• Source: Hospital General Universitario de Valencia
• Contact: Lucas Rovira, PhD
• Phone: +34659276476
• Email: lucasrovira[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Intubation Complication
• Difficult Intubation

Intervention

Device:
• Cleverscope
the device is used in patients without difficult airways predictors
• Laryngoscope / Videolaryngoscope C-MAC® Storz
the device is used in patients with difficult airways predictors

Locations

Country	Name	City	State
Spain	Lucas Rovira	La Pobla De Vallbona	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital General Universitario de Valencia	FIPSE

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cormack-Lehane Glotic visualization scale (I(complete view, easy to intubate)-IV(no view, imposible to intubate)	degree of glotis visualization	intraoperative
Secondary	First attempt intubation success rate	the rate of traqueal tube pass through vocal cords at first attemps.	intraoperative
Secondary	overall success intubation rate with same device	it could include more attempts	intraoperative
Secondary	time to success	time wasted from device inserted into mouth to inflate tracheal tube	intraoperative
Secondary	complications rate	register complications during intubation or due device usage. like hemorrage, mucosal laceration,	intraoperative