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Clinical Trials/NCT02395419
NCT02395419
Unknown
Not Applicable

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

Manuel Ángel Gómez-Ríos1 site in 1 country48 target enrollmentOctober 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endotracheal Intubation
Sponsor
Manuel Ángel Gómez-Ríos
Enrollment
48
Locations
1
Primary Endpoint
Total time of successful intubation
Last Updated
9 years ago

Overview

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) and the Airtraq (Prodol Meditec, Vizcaya, España) been designed specifically for the airway management. However, despite their use in clinical practice, there are no comparative studies.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
November 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Manuel Ángel Gómez-Ríos
Responsible Party
Sponsor Investigator
Principal Investigator

Manuel Ángel Gómez-Ríos

M.D.

Complexo Hospitalario Universitario de A Coruña

Eligibility 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.

Exclusion Criteria

  • Failure to meet the above criteria
  • Pregnancy
  • Allergy to any drug included in the protocol.

Outcomes

Primary Outcomes

Total time of successful intubation

Time Frame: Time of Orotracheal intubation (TOTI)

Secondary Outcomes

  • hemodinamic response(OTI pre and postintubation (time minutes))
  • difficulty in intubation (IDS scale)(TOTI)
  • number of maneuvers(TOTI)
  • percentage of glottic opening (POGO Score)(TOTI)
  • Position taken by the anesthesiologist during orotracheal intubation(TOTI)
  • Number of attempts of endotracheal intubation(TOTI)
  • Complications(OTI and postintubation (24 hours))
  • endotracheal intubation success rate of each device(TOTI)
  • Degree of satisfaction(time of postintubation (ten minutes))

Study Sites (1)

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