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The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252222
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Giuseppe Pascarella, Campus Bio-Medico University

Tracking Information
First Submitted Date  ICMJE January 30, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE December 4, 2018
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • Tracheal intubation rate [ Time Frame: 30 minutes ]
    successful tracheal intubation rate using VL3 video laryngoscope
  • Number of attempts [ Time Frame: 30 minutes ]
    Number of attempts for a successful tracheal intubation
  • Total time of intubation [ Time Frame: 15 minutes ]
    Time needed to perform a tracheal intubation from the insertion of VL3 video laryngoscope into the patient mouth
  • Time to glottis visualization [ Time Frame: 15 minutes ]
    Time needed to visualize the glottis from the insertion of VL3 video laryngoscope into the patient mouth
  • Cormack-Lehane grade [ Time Frame: 15 minutes ]
    Cormack-Lehane grade observed at videolaryngoscopy
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • Need for external laryngeal pressure [ Time Frame: 15 minutes ]
    Need for external laryngeal pressure during laryngoscopy
  • Presence of post-laryngoscopy side effects [ Time Frame: 3 days ]
    Presence of post-laryngoscopy side effects (bleeding, postoperative sore throat and/or dysphonia)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults
Official Title  ICMJE The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults: a Prospective Pilot Study
Brief Summary We conducted an observational prospective pilot study to assess the efficacy of the VL3 videolaryngoscope for routinely tracheal intubation in 56 adults, in terms of successful rate, no. attempts and manoeuvre duration, including both normal and difficult airways.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Difficult Airway Intubation
Intervention  ICMJE Device: Videolaryngoscopy with VL3
Tracheal Intubation aided by VL3 Videolaryngoscope
Study Arms  ICMJE Experimental: VL3
Tracheal intubation with VL3 videolaryngoscope
Intervention: Device: Videolaryngoscopy with VL3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2020)
56
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 1, 2019
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients candidates for general anesthesia in elective surgery
  • Age over 18 years
  • ASA physical status I-III.

Exclusion Criteria:

  • Paediatric population
  • ASA physical status IV
  • Emergency tracheal intubation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04252222
Other Study ID Numbers  ICMJE 82/18 OSS ComET CBM
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Giuseppe Pascarella, Campus Bio-Medico University
Study Sponsor  ICMJE Campus Bio-Medico University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Campus Bio-Medico University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP