CompletedNCT02395432Updated Oct 12, 2016

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

An interventional study of orotracheal intubation in Endotracheal Intubation, sponsored by Manuel Ángel Gómez-Ríos. Completed at 1 site in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-10-12.

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

Phase: Not applicable
Study type: Interventional
Enrollment: 133
Allocation: Randomized
Ages: 18 Years to 100 Years
Sex: All

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) has been designed specifically for the airway management. However, despite its use in clinical practice, there are no comparative studies regarding direct laryngoscopy.

Conditions studied

Endotracheal Intubation

In context

Lead sponsor

Manuel Ángel Gómez-Ríos is the lead sponsor of 5 studies on the registry; none are open to participants now.

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

Who can participate

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

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

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 133 participants (actual)

Study arms

Active comparator
Totaltrack
OTI with Totaltrack
Device: orotracheal intubation
Active comparator
Macintosh Laryngoscope
OTI with Macintosh Laryngoscope
Device: orotracheal intubation

Interventions

Deviceorotracheal intubation

What researchers measure

Primary outcomes

Total time of successful intubation
Time frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)

Secondary outcomes

IDS Scale
Time frame: TOTI (up to 1 hour)
POGO Score
Time frame: TOTI (up to 1 hour)
number of maneuvers
Time frame: TOTI (up to 1 hour)
Number of attempts of endotracheal intubation
Time frame: TOTI (up to 1 hour)
Position taken by the anesthesiologist during orotracheal intubation
Time frame: TOTI (up to 1 hour)
hemodynamic response
heart ratio, Arterial pressure
Time frame: TOTI pre and postintubation (up to 10 minutes)
Complications
Visual Analogic Scale (0-10)
Time frame: TOTI and postintubation (up to 24 hours)
endotracheal intubation success rate of each device
Time frame: TOTI (up to 1 hour)
Degree of satisfaction
Visual Analogic Scale (0-10)
Time frame: time of postintubation (up to 10 minutes)

Study locations

1 site

Manuel Ángel Gómez Ríos
A Coruña, 15008, Spain

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02395432
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: Sep 2015
Primary completion: Oct 2016
Last update: Oct 12, 2016

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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

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