Intubation;Difficult
Conditions
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.
Interventions
DEVICEDirect 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.
DEVICEVividtrac 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.
DEVICEKingVision videolaryngoscope
During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a KingVision videolaryngoscope.
Sponsors
University of Pecs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Following informed consent participants are randomised into one of the device groups and general anaesthesia is induced. Primary intubation attempt is carried out with the randomised device. We do not disclose the result of randomisation with our participants prior to anaesthesia induction. Participants are already in surgical anaesthesia with muscle relaxation during the intubation attempt. As providers are the users of the intubation device masking is not possible in this regard. During outcome assessment we plan not to disclose which device was used for a certain group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Hungary
Contacts
Primary ContactGábor Woth, MD PhD
Backup ContactDóra Keresztes, MD
Outcome results
None listed