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A Study of Laryngoscopic Vision With the TotalTrack Device Versus Indirect Laryngoscopy

NCT03208140 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2018-05-11

No results posted yet for this study

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.

Conditions

  • Airway Obstruction
  • Difficult Intubation

Sponsors & Collaborators

  • Formacion Internacional para la Docencia e Investigación de la Vía Aérea

    lead OTHER

Principal Investigators

  • pedro Charco-Mora, MD, PhD · Formacion Internacional para la Docencia e Investigación de la Vía Aérea

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-01
Primary Completion
2017-11-01
Completion
2017-12-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03208140 on ClinicalTrials.gov