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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

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.

Condition or disease Intervention/treatment Phase
Difficult Airway Intubation Device: Videolaryngoscopy with VL3 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults: a Prospective Pilot Study
Actual Study Start Date : December 4, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019

Arm Intervention/treatment
Experimental: VL3
Tracheal intubation with VL3 videolaryngoscope
Device: Videolaryngoscopy with VL3
Tracheal Intubation aided by VL3 Videolaryngoscope




Primary Outcome Measures :
  1. Tracheal intubation rate [ Time Frame: 30 minutes ]
    successful tracheal intubation rate using VL3 video laryngoscope

  2. Number of attempts [ Time Frame: 30 minutes ]
    Number of attempts for a successful tracheal intubation

  3. 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

  4. 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

  5. Cormack-Lehane grade [ Time Frame: 15 minutes ]
    Cormack-Lehane grade observed at videolaryngoscopy


Secondary Outcome Measures :
  1. Need for external laryngeal pressure [ Time Frame: 15 minutes ]
    Need for external laryngeal pressure during laryngoscopy

  2. Presence of post-laryngoscopy side effects [ Time Frame: 3 days ]
    Presence of post-laryngoscopy side effects (bleeding, postoperative sore throat and/or dysphonia)



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:

  • 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

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): NCT04252222


Locations
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Italy
Università Campus Biomedico
Roma, Italy
Sponsors and Collaborators
Campus Bio-Medico University
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Responsible Party: Giuseppe Pascarella, Medical Doctor, Unit of Anesthesia and Intensive Care, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT04252222    
Other Study ID Numbers: 82/18 OSS ComET CBM
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
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