ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02395445
Recruitment Status : Completed
First Posted : March 23, 2015
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
Manuel Ángel Gómez-Ríos, Complexo Hospitalario Universitario de A Coruña

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Spain
Manuel Ángel Gómez-Ríos
A Coruña, Spain, 15008
Sponsors and Collaborators
Manuel Ángel Gómez-Ríos
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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