Clinical trial NCT02395432: A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Difficult Airway
Official title: A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Difficult Airway: a Randomised, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Intubation
Lead sponsor: Complexo Hospitalario Universitario de A Coruña
Sponsor class: OTHER
First posted: 2015-03-23
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endotracheal intubation is usually required to allow unrestricted surgical approach. The Macintosh laryngoscope is the standard method. However in certain situations as difficult airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic intubation is the gold standard in this scenario, however sometimes it is not possible due to failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA, Barcelona, Spain) has been designed specifically for the airway management. However, despite its use in clinical practice, there are no comparative studies regarding direct laryngoscopy.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective general anesthesia requiring OTI.
* Patients duly informed and they have signed the informed consent during the pre-anesthetic consultation, or be sought after due meditation, expressing its consent to the inclusion in the study.
* Age ≥18 years.
* ASA I-III.
* Sufficient intellectual capacity to understand the procedure and equipment used.
* Predictors of difficult airway (Mallampatti class III or IV; thyromental distance \<6 cm, sternomental distance \<12.5 cm, interincisal distance\<4.0 cm, bite test II or III, cervical mobility \<90 ° or history of difficult intubation).
* Thyroid surgery or present pharyngolaryngeal, glottic or cervical pathology
* BMI \>30kg / m2
* Not presenting risk factors for aspiration
* Not presenting respiratory disease, coronary or cerebral vascular.
* Do not have a preoperative sore throat

Exclusion Criteria:

* Failure to meet the above criteria
* Pregnancy
* Allergy to any drug included in the protocol.

Primary outcomes:
measure: Total time of successful intubation
timeFrame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
Secondary outcomes:
measure: IDS Scale
timeFrame: TOTI (up to 1 hour)
measure: POGO Score
timeFrame: TOTI (up to 1 hour)
measure: number of maneuvers
timeFrame: TOTI (up to 1 hour)
measure: Number of attempts of endotracheal intubation
timeFrame: TOTI (up to 1 hour)
measure: Position taken by the anesthesiologist during orotracheal intubation
timeFrame: TOTI (up to 1 hour)
measure: hemodynamic response
timeFrame: TOTI pre and postintubation (up to 10 minutes)
measure: Complications
timeFrame: TOTI and postintubation (up to 24 hours)
measure: endotracheal intubation success rate of each device
timeFrame: TOTI (up to 1 hour)
measure: Degree of satisfaction
timeFrame: time of postintubation (up to 10 minutes)
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Manuel Ángel Gómez Ríos
Study officials:
References:
citation: Pearce A. Evaluation of the airway and preparation for difficulty. Best Pract Res Clin Anaesthesiol. 2005 Dec;19(4):559-79. doi: 10.1016/j.bpa.2005.07.004.
citation: Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
citation: Ochroch EA, Hollander JE, Kush S, Shofer FS, Levitan RM. Assessment of laryngeal view: percentage of glottic opening score vs Cormack and Lehane grading. Can J Anaesth. 1999 Oct;46(10):987-90. doi: 10.1007/BF03013137.