A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Routine Airway Management
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ClinicalTrials.gov Identifier: NCT02395445 |
Recruitment Status :
Completed
First Posted : March 23, 2015
Last Update Posted : November 7, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endotracheal Intubation | Device: orotracheal intubation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 205 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Routine Airway Management: a Randomised, Controlled Clinical Trial |
Study Start Date : | September 2015 |
Actual Primary Completion Date : | November 2016 |
Actual Study Completion Date : | November 2016 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Totaltrack
Indirect laryngoscopy
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Device: orotracheal intubation |
Active Comparator: Macintosh Laryngoscope
Direct laryngoscopy
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Device: orotracheal intubation |
- Total time of successful intubation with the Macintosh laryngoscope and TotalTrack. [ Time Frame: Time of Orotracheal intubation (TOTI) (up to 1 hour) ]
- 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 [ Time Frame: OTI pre and postintubation (up to 10 minutes) ]Heart Ratio, Arterial Pressure
- Complications [ Time Frame: OTI and postintubation ( up to 24 hours) ]
- endotracheal intubation success rate of each device [ Time Frame: TOTI (up to 1 hour) ]
- Degree of satisfaction [ Time Frame: time of postintubation (up to 10 minutes) ]Visual Analogic Scale

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395445
Spain | |
Manuel Ángel Gómez-Ríos | |
A Coruña, Spain, 15008 |
Publications:
Responsible Party: | Manuel Ángel Gómez-Ríos, M.D., Complexo Hospitalario Universitario de A Coruña |
ClinicalTrials.gov Identifier: | NCT02395445 History of Changes |
Other Study ID Numbers: |
MGR-TT-2015-F1 |
First Posted: | March 23, 2015 Key Record Dates |
Last Update Posted: | November 7, 2016 |
Last Verified: | November 2016 |