A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Difficult Airway

Study Overview
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Brief Summary
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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.

Official Title
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A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Difficult Airway: a Randomised, Controlled Clinical Trial

Conditions
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Endotracheal Intubation

Intervention / Treatment
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* Device: orotracheal intubation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Totaltrack<br>OTI with Totaltrack | Device: orotracheal intubation<br> <br> |
| Active Comparator: Macintosh Laryngoscope<br>OTI with Macintosh Laryngoscope | Device: orotracheal intubation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time of successful intubation |  | Time of Orotracheal intubation (TOTI) (up to 1 hour) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IDS Scale |  | TOTI (up to 1 hour) | 
| POGO Score |  | TOTI (up to 1 hour) | 
| number of maneuvers |  | TOTI (up to 1 hour) | 
| Number of attempts of endotracheal intubation |  | TOTI (up to 1 hour) | 
| Position taken by the anesthesiologist during orotracheal intubation |  | TOTI (up to 1 hour) | 
| hemodynamic response | heart ratio, Arterial pressure | TOTI pre and postintubation (up to 10 minutes) | 
| Complications | Visual Analogic Scale (0-10) | TOTI and postintubation (up to 24 hours) | 
| endotracheal intubation success rate of each device |  | TOTI (up to 1 hour) | 
| Degree of satisfaction | Visual Analogic Scale (0-10) | time of postintubation (up to 10 minutes) |