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Completed

NCT Number: NCT02395445

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

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

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Key information

Conditions

Endotracheal Intubation

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manuel Ángel Gómez-Ríos

A Coruña, 15008, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

orotracheal intubation

Device

Primary outcomes

  1. Total time of successful intubation with the Macintosh laryngoscope and TotalTrack.

    Time frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Manuel Ángel Gómez-Ríos

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 23, 2015
Registry last updated
Nov 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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