Clinical trial NCT03902704: Safety and Efficacy of Cleverscope. A New Medical Device for Tracheal Intubation
Official title: Safety and Efficacy Assessment of a New Tracheal Intubation Device Cleverscope. Success Rate of Cleverscope in Patients With Suspected Difficult Airway.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia Intubation Complication
Difficult Intubation
Keywords: videolaryngoscopy
tracheal intubation
Lead sponsor: Hospital General Universitario de Valencia
Sponsor class: OTHER
Collaborators: name: FIPSE
First posted: 2019-04-04
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: part 1 its single group of participants(50 patients without difficult airways predictors). this group receives direct laringoscopy with common laryngoscope (L) during the initial phase of the trial, followed by videolaryngoscope (VL) Cleverscope (used for intubation) during a later phase.

part 2 of the study its two-by-two cross-over assignment involves two groups of participants(84 patients with difficult airways predictors). One group receives VL with C-MAC during the initial phase of the trial, followed by Cleverscope for intubation during a later phase. The other group receives VL with Cleverscope during the initial phase, followed by C-MAC VL used for intubation. So during the part 2 trial, participants "cross over" to the other videolaringoscopy.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cormack-Lehane Glotic visualization scale (I(complete view, easy to intubate)-IV(no view, imposible to intubate)
timeFrame: intraoperative
Secondary outcomes:
measure: First attempt intubation success rate
timeFrame: intraoperative
measure: overall success intubation rate with same device
timeFrame: intraoperative
measure: time to success
timeFrame: intraoperative
measure: complications rate
timeFrame: intraoperative
Other outcomes:
Locations:
city: La Pobla De Vallbona
country: Spain
facility: Lucas Rovira
state: Valencia
Study officials:
References: