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

• ClinicalTrials.gov Identifier: NCT02395445
• Recruitment Status: Completed
• First Posted: March 23, 2015
• Last Update Posted: November 7, 2016
• Sponsor: Manuel Ángel Gómez-Ríos
• Information provided by (Responsible Party): Manuel Ángel Gómez-Ríos, Complexo Hospitalario Universitario de A Coruña

Study Description

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

Condition or disease	Intervention/treatment	Phase
Endotracheal Intubation	Device: orotracheal intubation	Not Applicable

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Totaltrack; Indirect laryngoscopy	Device: orotracheal intubation
Active Comparator: Macintosh Laryngoscope; Direct laryngoscopy	Device: orotracheal intubation

Outcome Measures

Primary Outcome Measures :

1. Total time of successful intubation with the Macintosh laryngoscope and TotalTrack. [ Time Frame: Time of Orotracheal intubation (TOTI) (up to 1 hour) ]

Secondary Outcome Measures :

1. IDS Scale [ Time Frame: TOTI (up to 1 hour) ]
2. POGO Score [ Time Frame: TOTI (up to 1 hour) ]
3. number of maneuvers [ Time Frame: TOTI (up to 1 hour) ]
4. Number of attempts of endotracheal intubation [ Time Frame: TOTI (up to 1 hour) ]
5. Position taken by the anesthesiologist during orotracheal intubation [ Time Frame: TOTI (up to 1 hour) ]
6. hemodynamic response [ Time Frame: OTI pre and postintubation (up to 10 minutes) ]
   Heart Ratio, Arterial Pressure
7. Complications [ Time Frame: OTI and postintubation ( up to 24 hours) ]
8. endotracheal intubation success rate of each device [ Time Frame: TOTI (up to 1 hour) ]
9. Degree of satisfaction [ Time Frame: time of postintubation (up to 10 minutes) ]
   Visual Analogic Scale

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Spain

Manuel Ángel Gómez-Ríos

A Coruña, Spain, 15008

Sponsors and Collaborators

Manuel Ángel Gómez-Ríos

More Information

Publications:

Pearce A. Evaluation of the airway and preparation for difficulty. Best Pract Res Clin Anaesthesiol. 2005 Dec;19(4):559-79. Review.

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.

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.

• 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
• Last Update Posted: November 7, 2016
• Last Verified: November 2016