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

M

Manuel Ángel Gómez-Ríos

Status

Unknown

Conditions

Endotracheal Intubation

Treatments

Device: Orotracheal intubation with Airtraq
Device: Orotracheal intubation with Totaltrack

Study type

Interventional

Funder types

Other

Identifiers

NCT02395406
MGR-TAT-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) and the Airtraq (Prodol Meditec, Vizcaya, España) been designed specifically for the airway management. However, despite their use in clinical practice, there are no comparative studies.

Enrollment

48 estimated 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 (Mallampati 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)

48 participants in 2 patient groups

Totaltrack
Active Comparator group
Description:
OTI with Totaltrack
Treatment:
Device: Orotracheal intubation with Totaltrack
Airtraq
Active Comparator group
Description:
OTI with Airtraq
Treatment:
Device: Orotracheal intubation with Airtraq

Trial contacts and locations

1

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Central trial contact

Manuel Á Gómez-Ríos, MD

Data sourced from clinicaltrials.gov

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