Comparison of the Vividtrac™ and Other Videolaryngoscopes in Clinical Practice

Intubation;Difficult Clinical Trial

Official title:

Comparison of Necessary Time for Successful Intubation With the Vividtrac™ and KingVision™ Videolaryngoscopes and Macintosh Blade Direct Laryngoscopy in Clinical Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03271008
• Other study ID #: 6328
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2017
• Last updated: August 31, 2017
• Start date: January 1, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: August 2017
• Source: University of Pecs
• Contact: Gábor Woth, MD PhD
• Phone: +36703729231
• Email: glwoth[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of various videolaryngoscope devices (Vividtrac™ and KingVision™) and direct laryngoscopy with Macintosh blade regarding laryngoscopy time, intubation time, intubation success rate, percentage of visible glottic opening (POGO score) in elective and acute clinical anaesthesiology practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• written informed consent

• over 18 years of age

• elective intervention

• no anticipated difficult airway or intubation

• preoperative anaesthesia risk assessment by American Society of Anaesthesiologists (ASA) physical status classification: ASA grade I-II

Exclusion Criteria:

Related Conditions & MeSH terms

• Intubation;Difficult

Intervention

Device:
• Direct laryngoscopy
During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a size 4 (or size 3 if necessary) Macintosh blade direct laryngoscope.
• Vividtrac videolaryngoscope
During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a Vividtrac videolaryngoscope connected to a tablet or smartphone.
• KingVision videolaryngoscope
During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a KingVision videolaryngoscope.

Locations

Country	Name	City	State
Hungary	University of Pécs, Dept. of Anaesthesia and Intensive Care	Pécs	Baranya county

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

References & Publications (1)

Rendeki S, Keresztes D, Woth G, Mérei Á, Rozanovic M, Rendeki M, Farkas J, Mühl D, Nagy B. Comparison of VividTrac®, Airtraq®, King Vision®, Macintosh Laryngoscope and a Custom-Made Videolaryngoscope for difficult and normal airways in mannequins by novices. BMC Anesthesiol. 2017 May 26;17(1):68. doi: 10.1186/s12871-017-0362-y. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation time	Time necessary to secure airway during the induction of general anesthesia. Intubation time is measured from the point the airway device crosses the interdental line until the completion of intubation with insufflated cuffed endotracheal tube (secured airway).	Measured once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
Secondary	Laryngoscopy time	Time necessary to achieve best visualisation of the glottic opening.	Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
Secondary	Percentage of glottic opening (POGO) score	The POGO score describes the best view of the glottic opening compared to the anatomical picture of the glottis. During direct laryngoscopy the investigator registers an approximate socre, while video laryngoscopy records are assessed by an independent investigator.	Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
Secondary	Tube insertion time	Time necessary for the operator to insert the cuffed endotracheal tube inside the proximal part of the trachea through the glottic opening. Tube insertion time is measured after the investigator finished the search for the glottic opening, achieved best view and decided to insert the tube into the trachea until the cuff is inflated and the airway is secured.	Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
Secondary	Primary intubation attempt success rate	All intubation attempts must be finished within 120 seconds or the investigator should give up the attempt and reoxygenize the patient before another attempt. If the investigator finished within the 120 seconds time frame we assess endotracheal tube position by capnography and auscultation. The attempt is regarded successful if the tube is in the right position and the airway is secured.	Measured once after intubation. Up to 120 seconds following the start of intubation attempt.