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

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

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.

Study Overview

• Status: Completed
• Conditions: Endotracheal Intubation
• Intervention / Treatment: Device: orotracheal intubation

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain, 15008
    • Manuel Ángel Gómez Ríos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Totaltrack; OTI with Totaltrack	Device: orotracheal intubation
Active Comparator: Macintosh Laryngoscope; OTI with Macintosh Laryngoscope	Device: orotracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Manuel Ángel Gómez-Ríos

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: March 9, 2015
• First Submitted That Met QC Criteria: March 17, 2015
• First Posted (Estimate): March 23, 2015

Study Record Updates

• Last Update Posted (Estimate): October 12, 2016
• Last Update Submitted That Met QC Criteria: October 11, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: MGR-TT-2015-D1