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

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.

Study Overview

• Status: Unknown
• Conditions: Endotracheal Intubation
• Intervention / Treatment: Device: Orotracheal intubation with Totaltrack; Device: Orotracheal intubation with Airtraq

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel G Gómez-Ríos, MD; Phone Number: +34636909413; Email: magoris@hotmail.com

Study Locations

• Spain
  • A Coruña, Spain, 15006
    • Recruiting
    • Manuel Gómez Ríos
    • Contact: Manuel Á Gómez-Ríos; Phone Number: +34636909413; Email: magoris@hotmail.com

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.
• Do not submit 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).
• Do not undergo 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 sore throat preoperative

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: Airtraq; OTI with Airtraq	Device: Orotracheal intubation with Airtraq
Active Comparator: Totaltrack; OTI with TotalTrack	Device: Orotracheal intubation with Totaltrack

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total time of successful intubation	Time of Orotracheal intubation (TOTI)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of glottic opening (POGO Score)		TOTI
number of maneuvers		TOTI
Number of attempts of endotracheal intubation		TOTI
Position taken by the anesthesiologist during orotracheal intubation		TOTI
Complications		OTI and postintubation (24 hours)
endotracheal intubation success rate of each device		TOTI
Degree of satisfaction	Visual Analogic Scale	time of postintubation (ten minutes)
difficulty in intubation (IDS scale)		TOTI
hemodinamic response	heart ratio, arterial pressure	OTI pre and postintubation (time minutes)
hemodinamic response	arterial pressure	OTI pre and postintubation (time 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: October 1, 2016
• Primary Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: March 10, 2015
• First Submitted That Met QC Criteria: March 17, 2015
• First Posted (Estimate): March 23, 2015

Study Record Updates

• Last Update Posted (Estimate): October 17, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: MGR-TAT-2015-F1