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| Name | Class |
|---|---|
| Hospital Clinico Universitario de Santiago | OTHER |
| Complexo Hospitalario de Ourense | OTHER |
| Complejo Hospitalario Universitario de Pontevedra | OTHER |
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The usual intubation technique in the operating room is based on direct laryngoscopy, using a standard Macintosh laryngoscope. However, this skill is not easy to acquire and requires adecuate training. Videolaryngoscopes are becoming a widely accepted airway management technique. because offer better view of the glottis and are easy to use. In addition, indirect laryngoscopes are useful for tracheal intubation by novice operators because of the feedback that supervisors can offer during intubation.
The goal of this clinical trial is to learn which intubation technique performed by residents of anesthesia in the operating room is better.
The main questions it aims to answer are:
The study will randomize, by means of a computer-generated randomization, approximately 1008 adults in two groups: Conventional group (Laryngoscope with Macintosh Blade) and Videolaryngoscope group (Mac-Style Blade) to be intubated in the operating room by an anesthesia resident.
Success rate of the selected technique (first attempt), overall success rate, number of attempts, complications, and duration of insertion for technique will be noted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laryngoscope Group | Active Comparator | For patients assigned to the Laryngoscope Group, the operator will use a Macintosh laryngoscope for the first laryngoscopy attempt |
|
| Videolaryngoscope Group | Active Comparator | For patients assigned to the Videolaryngoscope Group, the operator will use a videolaryngoscope with Mac-Style Blade for the first laryngoscopy attempt |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intubation with standard laryngoscope | Device | Anesthesia resident will intubate using a standard laryngoscope. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the first attempt success rate (percentage) | Success on the first attempt is defined as successfully passing the tube through the vocal cords in a single laryngoscopy attempt and inserting the endotracheal tube into the trachea | During intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the glottic view in the modified Cormack-Lehane scale between the two approaches | Modified Cormack-Lehane grade of glottic view:
| During intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| María Bermúdez María Bermúdez López, MD | Hospital Universitario Lucus Augusti | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de A Coruña | A Coruña | A Coruña | Spain | |||
| Hospital Universitario de Ferrol |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26765472 | Background | Liu ZJ, Yi J, Guo WJ, Ma C, Huang YG. Comparison of McGrath Series 3 and Macintosh Laryngoscopes for Tracheal Intubation in Patients With Normal Airway by Inexperienced Anesthetists: A Randomized Study. Medicine (Baltimore). 2016 Jan;95(2):e2514. doi: 10.1097/MD.0000000000002514. | |
| 38580479 | Background | Taboada M, Estany-Gestal A, Rial M, Carinena A, Martinez A, Selas S, Eiras M, Veiras S, Ferreiroa E, Cardalda B, Lopez C, Calvo A, Fernandez J, Alvarez J, Alcantara JM, Seoane-Pillado T. Impact of Universal Use of the McGrath Videolaryngoscope as a Device for All Intubations in the Cardiac Operating Room. A Prospective Before-After VIDEOLAR-CAR Study. J Cardiothorac Vasc Anesth. 2024 Jul;38(7):1499-1505. doi: 10.1053/j.jvca.2024.03.016. Epub 2024 Mar 15. |
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| Complexo Hospitalario Universitario de A Coruña |
| OTHER |
| Complejo Hospitalario Universitario de Vigo | OTHER |
| Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | OTHER |
| Hospital Arquitecto Marcide. Ferrol. A Coruña. (Spain) | UNKNOWN |
Laryngoscope Group: anesthesia resident intubation with Macintosh standard laryngoscope .
Videolaryngoscope Group: anesthesia resident intubation with videolaryngoscope Mac-Style Blade.
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| Intubation with video laryngoscope | Device | Anesthesia resident will intubate using a videolaryngoscope (Storz C-MAC, McGrath, Glidescope or other videolaryngoscope) |
|
| Difference in percentage of "easy intubation" | To compare the difference in "easy intubation," defined as a Cormack-Lehane grade I-IIa glottic view and successful intubation on the first attempt, between the two intubation approaches. | During intubation |
| Duration of laryngoscopy and tracheal intubation | The interval (in seconds) between the first insertion of a laryngoscope blade into the mouth and the final placement of a tube in the trachea. | During intubation |
| Number of attempts to cannulate the trachea with an endotracheal tube | Number of attempts to cannulate the trachea with an endotracheal tube | During intubation |
| Number of attempts to cannulate the trachea with a bougie. | Number of attempts to cannulate the trachea with a bougie | During intubation |
| Need to change the device for intubation | Need to replace by another videolaryngoscope, a different angled blade, requirement for a fiberoptic bronchoscope... | During intubation |
| Need for additional airway equipment | Airway equipment: bougie, stylet, other videolaryngoscope, others. | During intubation |
| Operator-assessed difficulty of intubation | Operator-assessed difficulty of intubation
| During intubation |
| Use of external laryngeal pressure | External laryngeal pressure: Sellick maneuver or BURP | During intubation |
| Reason for failure to intubate on the first attempt | Reason for failure among those who did not meet the primary outcome (successful intubation on the first attempt):
| During intubation |
| Complications during intubation | Complications during the procedure and within the following 10 minutes, including: hypotension (SBP < 80 mmHg), hypotension (SBP < 65 mmHg), O₂ saturation < 90%, O₂ saturation < 80%, bronchoaspiration, esophageal intubation, dental injury, airway injury, and others. | Participants will be followed from the beginning of the intervention to 10 minutes after the intervention |
| Ferrol |
| A Coruña |
| Spain |
| Complejo Hospitalario Universitario de Santiago | Santiago | A Coruña | Spain |
| Hospital Universitario Lucus Agusti | Lugo | Lugo | 27003 | Spain |
| Hospital Universitario de La Princesa | Madrid | Madrid | Spain |
| Complexo Hospitalario Universitario de Ourense | Ourense | Ourense | Spain |
| Complexo Hospitalario de Pontevedra | Pontevedra | Pontevedra | Spain |
| Complejo Hospitalario Alvaro Cunqueiro Vigo | Vigo | Pontevedra | Spain |
| Hospital POVISA de Vigo | Vigo | Pontevedra | Spain |
| 37848388 | Background | Yamamoto Y, Kimura S, Kuniyoshi H, Hiroe T, Terui T, Kase Y. Novice residents' endotracheal intubation skill retention on a simulated mannequin after rotating at an anaesthesiology department: a randomized controlled study. J Int Med Res. 2023 Oct;51(10):3000605231206313. doi: 10.1177/03000605231206313. |
| 41534770 | Derived | Taboada M, Bermudez M, Fernandez J, Estany-Gestal A, Amate JJ, Ruido R, Amor M, Mato R, Barreiro C, Martinez P, Ramasco F, Vazquez O, Seoane-Pillado T. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation by anesthesia residents in the operating room: The randomized multicenter VILARE trial protocol. Rev Esp Anestesiol Reanim (Engl Ed). 2026 Feb;73(2):501988. doi: 10.1016/j.redare.2026.501988. Epub 2026 Jan 12. |
| ID | Term |
|---|---|
| D007440 | Intubation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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