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

NCT02395432 | Completed

• 1 other identifier: MGR-TT-2015-D1
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Endotracheal Intubation

Outcome Measures

Primary Outcomes (1)

• Total time of successful intubation

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

Secondary Outcomes (9)

• 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)

Study Arms (2)

Totaltrack

ACTIVE COMPARATOR

OTI with Totaltrack

Device: orotracheal intubation

Macintosh Laryngoscope

ACTIVE COMPARATOR

OTI with Macintosh Laryngoscope

Device: orotracheal intubation

Interventions

orotracheal intubation DEVICE

Macintosh Laryngoscope; Totaltrack

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective general anesthesia requiring OTI.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Manuel Ángel Gómez-Ríos: lead

Study Sites (1)

Manuel Ángel Gómez Ríos

A Coruña, A Coruña, 15008, Spain

Location

Related Publications (3)

• 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.

  PMID: 16408534 BACKGROUND

• 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.

  PMID: 9416711 BACKGROUND

• 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.

  PMID: 10522589 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 23, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2016
• Last Updated: October 12, 2016

Record last verified: 2016-10

Locations

ES (1)