Comparison of the Vividtrac™ and Other Videolaryngoscopes in Clinical Practice

Not Applicable

• Conditions: Intubation;Difficult

• Registration Number: NCT03271008
• Lead Sponsor: University of Pecs

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-05-11
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-31
• Last Update Submitted: 2017-08-31
• Study First Posted: 2017-09-01
• Last Update Posted: 2017-09-01
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intubation time	Measured once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of glottic opening (POGO) score	Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.	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.
Tube insertion time	Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.	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.
Laryngoscopy time	Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.	Time necessary to achieve best visualisation of the glottic opening.
Primary intubation attempt success rate	Measured once after intubation. Up to 120 seconds following the start of intubation attempt.	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.

Trial Locations

Locations (1)

University of Pécs, Dept. of Anaesthesia and Intensive Care; 🇭🇺 Pécs, Baranya county, Hungary