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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
Sponsor:
Information provided by (Responsible Party):
Manuel Ángel Gómez-Ríos, Complexo Hospitalario Universitario de A Coruña

Tracking Information
First Submitted Date  ICMJE March 9, 2015
First Posted Date  ICMJE March 23, 2015
Last Update Posted Date November 7, 2016
Study Start Date  ICMJE September 2015
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2015)
Total time of successful intubation with the Macintosh laryngoscope and TotalTrack. [ Time Frame: Time of Orotracheal intubation (TOTI) (up to 1 hour) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02395445 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Routine Airway Management
Official Title  ICMJE A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Routine Airway Management: a Randomised, Controlled Clinical Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Endotracheal Intubation
Intervention  ICMJE Device: orotracheal intubation
Study Arms  ICMJE
  • Active Comparator: Totaltrack
    Indirect laryngoscopy
    Intervention: Device: orotracheal intubation
  • Active Comparator: Macintosh Laryngoscope
    Direct laryngoscopy
    Intervention: Device: orotracheal intubation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2016)
205
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2015)
48
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02395445
Other Study ID Numbers  ICMJE MGR-TT-2015-F1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Manuel Ángel Gómez-Ríos, Complexo Hospitalario Universitario de A Coruña
Study Sponsor  ICMJE Manuel Ángel Gómez-Ríos
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Complexo Hospitalario Universitario de A Coruña
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP