Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02395406
Other study ID # MGR-TAT-2015-D1
Secondary ID
Status Recruiting
Phase N/A
First received March 10, 2015
Last updated October 18, 2016
Start date October 2016

Study information

Verified date October 2016
Source Complexo Hospitalario Universitario de A Coruña
Contact Manuel Á Gómez-Ríos, MD
Phone +34636909413
Email magoris@hotmail.com
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 100 Years
Eligibility 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.

- 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).

- 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 preoperative sore throat

Exclusion Criteria:

- Failure to meet the above criteria

- Pregnancy

- Allergy to any drug included in the protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Orotracheal intubation with Totaltrack

Orotracheal intubation with Airtraq


Locations

Country Name City State
Spain Manuel Ángel Gómez-Ríos Coruña Galicia

Sponsors (1)

Lead Sponsor Collaborator
Manuel Ángel Gómez-Ríos

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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. — View Citation

Pearce A. Evaluation of the airway and preparation for difficulty. Best Pract Res Clin Anaesthesiol. 2005 Dec;19(4):559-79. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Total time of successful intubation Time of Orotracheal intubation (TOTI) No
Secondary difficulty in intubation (IDS Scale) TOTI No
Secondary percentage of glottic opening (POGO Score) TOTI No
Secondary number of maneuvers TOTI No
Secondary Number of attempts of endotracheal intubation TOTI No
Secondary Position taken by the anesthesiologist during orotracheal intubation TOTI No
Secondary hemodynamic response Heart Ratio TOTI pre and postintubation (ten minutes) No
Secondary Complications OTI and postintubation (24 hours) No
Secondary endotracheal intubation success rate of each device TOTI No
Secondary Degree of satisfaction Visual Analogic Scale time of postintubation (ten minutes) No
Secondary hemodynamic response Arterial Pressure TOTI pre and postintubation (ten minutes No
See also
  Status Clinical Trial Phase
Completed NCT06089187 - Comparing Endotracheal Tube Cuff Pressure in Laparoscopic Abdominal Surgery: Saline vs. Air Inflation N/A
Completed NCT02395432 - A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Difficult Airway N/A
Completed NCT02395445 - A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Routine Airway Management N/A
Unknown status NCT01041066 - Nicardipine Versus Labetalol During Intubation N/A
Completed NCT03284892 - Screening and Intervention of Postextubation Dysphagia N/A
Recruiting NCT02395419 - A Comparison of Tracheal Intubation Using the Totaltrack vs the Airtraq Laryngoscope in Routine Airway Management N/A
Enrolling by invitation NCT02277015 - Intubation During Pediatric Resuscitation N/A
Completed NCT01169467 - Cerebral Perfusion Pressure Using Precedex and Other Sedatives Phase 3
Completed NCT00620386 - Endotracheal Intubation Using Bonfils Fibrescope Without Neuromuscular Blockade Phase 2/Phase 3
Completed NCT05069844 - Preoperative Gum Chewing for Different Durations to Prevent Sore Throat After Endotracheal Intubation N/A
Enrolling by invitation NCT05620108 - Intubating Conditions of Neuromuscular Blockade N/A
Completed NCT02741921 - Conventional Double-lumen Tube vs VivaSight DL N/A
Recruiting NCT02295657 - Double Lumen Tube Intubation N/A
Completed NCT01488370 - Comparison of 2 Laryngoscopes for Endotracheal Intubation in Children Younger Than 2 Years Old N/A
Recruiting NCT01006668 - Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care Phase 3
Recruiting NCT04483895 - Comparison Between the Oro-Helical Length Technique and the 7-8-9 Rule in Determination of the Ideal Endotracheal Tube Insertion Depth in Neonates N/A
Completed NCT04141267 - Inhaled Sedation Using the Anesthetic-conserving Device ( ANACONDA) in Prehospital Emergency Medecine.
Completed NCT01490580 - Premedication Trial for Tracheal Intubation of the NEOnate Phase 2/Phase 3
Completed NCT03878797 - The Depth of Endotracheal Tube Insertion
Not yet recruiting NCT05495880 - Forearm-Supported Head Extension to Decrease Dental Contact N/A