A Prospective, Multicenter Comparative Study of Laryngoscopic Vision With the TotalTrack Device Versus Indirect Laryngoscopy in Patients With an Uncomplicated Airway Scheduled for Surgery in the Context of Routine Anesthetic Practice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- To determine whether the new TTK device improves laryngoscopic visualization
Study Overview
Brief Summary
Assessment of the airway forms part of routine anesthetic practice. However, the predictions referred to intubation or ventilation difficulties are usually inconclusive. In effect, the failure rate in predicting such difficulties exceeds 60%. In this scenario it is not possible to know whether a given patient will be difficult to intubate and ventilate. These are referred to as non-intubate and non-ventilate cases with a high risk of severe neurological complications and even death due to hypoxemia. According to all the clinical guides, the solution in such cases usually involves the use of supraglottic devices that rescue oxygenation through effective ventilation.
In the event of ventilation failure with a supraglottic device, it is currently not possible to know whether the device is correctly positioned, unless some other instrument such as a flexible fiberscope is used to visualize the anatomy beyond the ventilation device.
The TotalTrack is a new device with all the characteristics of a supraglottic device that moreover includes a camera at the tip, allowing us to confirm anatomical positioning with respect to the glottic structures. This device also allows intubation under indirect visualization of the glottis, thus adding the possibility of definitive patient lung isolation.
The primary objective of this study is to determine the capacity to visualize the glottic structures through the camera of the TotalTrack device, compared with glottic visualization afforded by indirect laryngoscopy in the same patient. The Cormack-Lehane scale and percentage of glottic opening (POGO) are used for this purpose.
The secondary objectives comprise assessment of the ventilation, intubation and TotalTrack device withdrawal times. The hemodynamic changes associated to both techniques during intubation and TotalTrack device withdrawal are also evaluated. Minimum patient oxygenation throughout the procedure is assessed. The sealing and ventilation pressures during operation of the TotalTrack device are recorded. Likewise, an analysis is made of the number of placement attempts, visualization improvement maneuvers, and minor complications associated to the use of the TotalTrack device (presence of blood upon withdrawal or pharyngeal pain), with their degree of severity.
Detailed Description
The study hypothesis is that the new TTK device improves laryngoscopic visualization compared with direct laryngoscopy, thereby facilitating orotracheal intubation success.
The null hypothesis is that the new TTK device does not improve visualization of the glottic structures, the intubation conditions, or intubation success compared with direct laryngoscopy.
- Objectives 3.1 Primary objective To determine whether the new TTK device improves laryngoscopic visualization as determined by the Cormack-Lehane scale and percentage of glottic opening (POGO), versus conventional laryngoscopy.
3.2 Secondary objectives
- To assess intubation success, the laryngoscopy and intubation times, sealing pressure and subjective difficulty with the TTK intubation device.
- To evaluate the hemodynamic impact, oxygenation and complications associated to the use of both intubation techniques.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with ASA score I-III
- •Age > 18 years
- •Signing of the informed consent document
Exclusion Criteria
- •Age < 18 years
- •Pregnant or breast-feeding women
- •Patients with known difficult airways
- •Patients requiring rapid sequence intubation
Outcomes
Primary Outcomes
To determine whether the new TTK device improves laryngoscopic visualization
Time Frame: Time of Orotracheal intubation (up to 1 hour)
To determine whether the new TTK device improves laryngoscopic visualization as determined by the Cormack-Lehane, versus conventional laryngoscopy.
Secondary Outcomes
- To assess the laryngoscopy times(Time of Orotracheal intubation (up to 1 hour))
- To assess the intubation times(Time of Orotracheal intubation (up to 1 hour))
- To determinate pressure sealing of the totaltrack device (laryngeal mask)(post totaltrack introduction and correct pressure ventilation (until 10 minutes))
- To determinate hemodynamic parameters during totaltrack insertion(Time postTotaltrack insertion (up to 10 minutes))
- To assess intubation success,(Time of Orotracheal intubation (up to 1 hour))
- To determinate hemodynamic parameters during direct laryngoscopy(Time post direct laryngoscopy (up to 10 minutes))
- To determinate hemodynamic parameters during intubation(Time postOrotracheal intubation (up to 10 minutes))
- To determinate complication of the technical intubation(immediately postintubation and 24 hours later (up to 24 hours))
Investigators
pedro charco mora
Director
Formacion Internacional para la Docencia e Investigación de la Vía Aérea