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

Manuel Ángel Gómez-Ríos

Status: Completed

Conditions: Endotracheal Intubation

Treatments: Device: orotracheal intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT02395432

MGR-TT-2015-D1

Details and patient eligibility

About

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.

Enrollment: 133 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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133 participants in 2 patient groups

Totaltrack

Active Comparator group

Description:

OTI with Totaltrack

Treatment:

Device: orotracheal intubation

Macintosh Laryngoscope

Active Comparator group

Description:

OTI with Macintosh Laryngoscope

Treatment:

Device: orotracheal intubation