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Status unknownNCT02395406Updated Oct 19, 2016

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

An interventional study of Orotracheal intubation with Totaltrack and Orotracheal intubation with Airtraq in Endotracheal Intubation, sponsored by Manuel Ángel Gómez-Ríos. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-10-19.

Sponsored by Manuel Ángel Gómez-Ríos · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
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Study 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) 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.

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Conditions studied

  • Endotracheal Intubation
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In context

Lead sponsor

Manuel Ángel Gómez-Ríos is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    Totaltrack

    OTI with Totaltrack

    Device: Orotracheal intubation with Totaltrack

  • Active comparator
    Airtraq

    OTI with Airtraq

    Device: Orotracheal intubation with Airtraq

Interventions

  • DeviceOrotracheal intubation with Totaltrack
  • DeviceOrotracheal intubation with Airtraq
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What researchers measure

Primary outcomes

  1. Total time of successful intubation

    Time frame: Time of Orotracheal intubation (TOTI)

Secondary outcomes

  1. difficulty in intubation (IDS Scale)

    Time frame: TOTI

  2. percentage of glottic opening (POGO Score)

    Time frame: TOTI

  3. number of maneuvers

    Time frame: TOTI

  4. Number of attempts of endotracheal intubation

    Time frame: TOTI

  5. Position taken by the anesthesiologist during orotracheal intubation

    Time frame: TOTI

  6. hemodynamic response

    Heart Ratio

    Time frame: TOTI pre and postintubation (ten minutes)

  7. Complications

    Time frame: OTI and postintubation (24 hours)

  8. endotracheal intubation success rate of each device

    Time frame: TOTI

  9. Degree of satisfaction

    Visual Analogic Scale

    Time frame: time of postintubation (ten minutes)

  10. hemodynamic response

    Arterial Pressure

    Time frame: TOTI pre and postintubation (ten minutes

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Study locations

1 of 1 sites recruiting
  • Manuel Ángel Gómez-Ríos
    A Coruña, Galicia 15008, Spain
    Recruiting
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References and documents

Publications

  • 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. PubMed 16408534 ↗
  • 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. PubMed 9416711 ↗
  • 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. PubMed 10522589 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02395406
Lead sponsor
Manuel Ángel Gómez-Ríos
Responsible party
Manuel Ángel Gómez-Ríos (M.D., Complexo Hospitalario Universitario de A Coruña) — Sponsor-investigator
First posted
Mar 23, 2015
Start date
Oct 2016
Primary completion
Nov 2017 (estimated)
Last update
Oct 19, 2016

Study contacts

Manuel Á Gómez-Ríos, MD
Contact
magoris@hotmail.com
+34636909413

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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