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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902704
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : June 7, 2019
Sponsor:
Collaborator:
FIPSE
Information provided by (Responsible Party):
Lucas Rovira, 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.

Condition or disease Intervention/treatment Phase
Anesthesia Intubation Complication Difficult Intubation Device: Cleverscope Device: Laryngoscope / Videolaryngoscope C-MAC® Storz Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Assessment of a New Tracheal Intubation Device Cleverscope. Success Rate of Cleverscope in Patients With Suspected Difficult Airway.
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

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




Primary Outcome Measures :
  1. Cormack-Lehane Glotic visualization scale (I(complete view, easy to intubate)-IV(no view, imposible to intubate) [ Time Frame: intraoperative ]
    degree of glotis visualization


Secondary Outcome Measures :
  1. First attempt intubation success rate [ Time Frame: intraoperative ]
    the rate of traqueal tube pass through vocal cords at first attemps.

  2. overall success intubation rate with same device [ Time Frame: intraoperative ]
    it could include more attempts

  3. time to success [ Time Frame: intraoperative ]
    time wasted from device inserted into mouth to inflate tracheal tube

  4. complications rate [ Time Frame: intraoperative ]
    register complications during intubation or due device usage. like hemorrage, mucosal laceration,



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902704


Contacts
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Contact: Lucas Rovira, PhD +34659276476 lucasrovira@gmail.com

Locations
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Spain
Lucas Rovira Recruiting
La Pobla De Vallbona, Valencia, Spain, 46185
Contact: Lucas Rovira, PhD    +34659276476    lucasrovira@gmail.com   
Principal Investigator: Lucas Rovira, PhD         
Sponsors and Collaborators
Hospital General Universitario de Valencia
FIPSE
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Responsible Party: Lucas Rovira, Principal Investigator, Hospital General Universitario de Valencia
ClinicalTrials.gov Identifier: NCT03902704    
Other Study ID Numbers: Rov-Clever-2017
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lucas Rovira, Hospital General Universitario de Valencia:
videolaryngoscopy
tracheal intubation