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

Endotracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395432
• Other study ID #: MGR-TT-2015-D1
• Status: Completed
• Phase: N/A
• First received: March 9, 2015
• Last updated: October 11, 2016
• Start date: September 2015

Study information

• Verified date: October 2016
• Source: Complexo Hospitalario Universitario de A Coruña
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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:

• Failure to meet the above criteria

• Pregnancy

• Allergy to any drug included in the protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endotracheal Intubation

Intervention

Device:
• orotracheal intubation

Locations

Country	Name	City	State
Spain	Manuel Ángel Gómez Ríos	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Manuel Ángel Gómez-Ríos

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total time of successful intubation		Time of Orotracheal intubation (TOTI) (up to 1 hour)	No
Secondary	IDS Scale		TOTI (up to 1 hour)	No
Secondary	POGO Score		TOTI (up to 1 hour)	No
Secondary	number of maneuvers		TOTI (up to 1 hour)	No
Secondary	Number of attempts of endotracheal intubation		TOTI (up to 1 hour)	No
Secondary	Position taken by the anesthesiologist during orotracheal intubation		TOTI (up to 1 hour)	No
Secondary	hemodynamic response	heart ratio, Arterial pressure	TOTI pre and postintubation (up to 10 minutes)	No
Secondary	Complications	Visual Analogic Scale (0-10)	TOTI and postintubation (up to 24 hours)	No
Secondary	endotracheal intubation success rate of each device		TOTI (up to 1 hour)	No
Secondary	Degree of satisfaction	Visual Analogic Scale (0-10)	time of postintubation (up to 10 minutes)	No