NCT02395445

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 23, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 7, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

March 9, 2015

Last Update Submit

November 4, 2016

Conditions

Endotracheal Intubation

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (9)

  • IDS Scale

    TOTI (up to 1 hour)

  • POGO Score

    TOTI (up to 1 hour)

  • number of maneuvers

    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)

  • +4 more secondary outcomes

Study Arms (2)

Totaltrack

ACTIVE COMPARATOR

Indirect laryngoscopy

Device: orotracheal intubation

Macintosh Laryngoscope

ACTIVE COMPARATOR

Direct laryngoscopy

Device: orotracheal intubation

Interventions

orotracheal intubationDEVICE
Macintosh LaryngoscopeTotaltrack

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective general anesthesia requiring OTI.
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manuel Ángel Gómez-Ríos

A Coruña, A Coruña, 15008, Spain

Location

Related Publications (3)

  • Pearce A. Evaluation of the airway and preparation for difficulty. Best Pract Res Clin Anaesthesiol. 2005 Dec;19(4):559-79. doi: 10.1016/j.bpa.2005.07.004.

    PMID: 16408534BACKGROUND

  • Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.

    PMID: 9416711BACKGROUND

  • Ochroch EA, Hollander JE, Kush S, Shofer FS, Levitan RM. Assessment of laryngeal view: percentage of glottic opening score vs Cormack and Lehane grading. Can J Anaesth. 1999 Oct;46(10):987-90. doi: 10.1007/BF03013137.

    PMID: 10522589BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 23, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 7, 2016

Record last verified: 2016-11

Locations

ES(1)