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

Not Applicable

Completed

• Conditions: Endotracheal Intubation
• Interventions: Device: orotracheal intubation

• Registration Number: NCT02395432
• Lead Sponsor: Manuel Ángel Gómez-Ríos

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-23
• Study Start: 2015-09
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Last Update Submitted: 2016-10-11
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Totaltrack	orotracheal intubation	OTI with Totaltrack
Macintosh Laryngoscope	orotracheal intubation	OTI with Macintosh Laryngoscope

Primary Outcome Measures

Name	Time	Method
Total time of successful intubation	Time of Orotracheal intubation (TOTI) (up to 1 hour)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Manuel Ángel Gómez Ríos; 🇪🇸 A Coruña, Spain