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

Hospital General Universitario de Valencia

Status: Unknown

Conditions: Difficult Intubation; Anesthesia Intubation Complication

Treatments: Device: Laryngoscope / Videolaryngoscope C-MAC® Storz; Device: Cleverscope

Study type: Interventional

Funder types: Other

Identifiers

NCT03902704

Rov-Clever-2017

Details and patient eligibility

About

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

Full 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.

Enrollment: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Cleverscope

Experimental group

Description:

Cleverscope is a new videolaryngoscope used for tracheal intubation. in this group we use this device to intubate participants.

Treatment:

Device: Cleverscope

Laryngoscope / Videolaryngoscope C-MAC® Storz

Active Comparator group

Description:

in this group we use a standart comercial device for intubation (laryngoscope or C-MAC) to intubate participants

Treatment:

Device: Laryngoscope / Videolaryngoscope C-MAC® Storz