Safety and Efficacy of Cleverscope. A New Medical Device for Tracheal Intubation
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|ClinicalTrials.gov Identifier: NCT03902704|
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : June 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia Intubation Complication Difficult Intubation||Device: Cleverscope Device: Laryngoscope / Videolaryngoscope C-MAC® Storz||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||134 participants|
|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)|
|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|
Cleverscope is a new videolaryngoscope used for tracheal intubation. in this group we use this device to intubate participants.
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
- Cormack-Lehane Glotic visualization scale (I(complete view, easy to intubate)-IV(no view, imposible to intubate) [ Time Frame: intraoperative ]degree of glotis visualization
- First attempt intubation success rate [ Time Frame: intraoperative ]the rate of traqueal tube pass through vocal cords at first attemps.
- overall success intubation rate with same device [ Time Frame: intraoperative ]it could include more attempts
- time to success [ Time Frame: intraoperative ]time wasted from device inserted into mouth to inflate tracheal tube
- complications rate [ Time Frame: intraoperative ]register complications during intubation or due device usage. like hemorrage, mucosal laceration,
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
|Contact: Lucas Rovira, PhDfirstname.lastname@example.org|
|La Pobla De Vallbona, Valencia, Spain, 46185|
|Contact: Lucas Rovira, PhD +34659276476 email@example.com|
|Principal Investigator: Lucas Rovira, PhD|