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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02395445
Enrollment
205
Registered
2015-03-23
Start date
2015-09-30
Completion date
2016-11-30
Last updated
2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Intubation

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

Interventions

DEVICEorotracheal intubation

Sponsors

Manuel Ángel Gómez-Ríos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
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. * 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.

Design outcomes

Primary

MeasureTime frame
Total time of successful intubation with the Macintosh laryngoscope and TotalTrack.Time of Orotracheal intubation (TOTI) (up to 1 hour)

Secondary

MeasureTime frameDescription
POGO ScoreTOTI (up to 1 hour)
number of maneuversTOTI (up to 1 hour)
Number of attempts of endotracheal intubationTOTI (up to 1 hour)
Position taken by the anesthesiologist during orotracheal intubationTOTI (up to 1 hour)
IDS ScaleTOTI (up to 1 hour)
ComplicationsOTI and postintubation ( up to 24 hours)
endotracheal intubation success rate of each deviceTOTI (up to 1 hour)
Degree of satisfactiontime of postintubation (up to 10 minutes)Visual Analogic Scale
hemodynamic responseOTI pre and postintubation (up to 10 minutes)Heart Ratio, Arterial Pressure

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026