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

Manuel Ángel Gómez-Ríos1 site in 1 country133 target enrollmentSeptember 2015

ConditionsEndotracheal Intubation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Endotracheal Intubation
Sponsor: Manuel Ángel Gómez-Ríos
Enrollment: 133
Locations: 1
Primary Endpoint: Total time of successful intubation
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

October 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Manuel Ángel Gómez-Ríos

Responsible Party

Sponsor Investigator

Principal Investigator

Manuel Ángel Gómez-Ríos

M.D.

Complexo Hospitalario Universitario de A Coruña

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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Total time of successful intubation

Time Frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)

Secondary Outcomes

Complications(TOTI and postintubation (up to 24 hours))
POGO Score(TOTI (up to 1 hour))
endotracheal intubation success rate of each device(TOTI (up to 1 hour))
Degree of satisfaction(time of postintubation (up to 10 minutes))
IDS Scale(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(TOTI pre and postintubation (up to 10 minutes))