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Tracheal intubation in the intensive care unit (ICU) is associated with high incidence of difficult intubation and complications. Videolaryngoscopes (VLs) devices have been proposed to improve airway management, and the use of VLs are recommended as first-line or after a first-attempt failure using direct laryngoscopy in ICU airway management algorithms. Although until relatively few years ago there were doubts about whether videolaryngoscopes had advantages over direct laryngoscopy for endotracheal intubation (ETI) in critically ill patients, two recent studies (DEVICE (1), INTUBATE (2)), and a Cochrane review (3) have confirmed that videolaryn should be used?, and what is the best blade? . There are two types of blades commonly used with videolaryngoscopes: the "Macintosh" blade with a slight curvature, and hyperangulated blades. The "Macintosh" blades have a lower angle of vision, but they have the advantage of being similar to the blades commonly used in direct laryngoscopy, making them easy to use for the person performing the ETI. Hyperangulated blades have a greater angle of vision, improving glottic visualization, especially in patients with an anterior glottis. However, the need to overcome this angulation could potentially hinder the passage of the endotracheal tube to the vocal cords. It is unknown if either blade has any advantage for intubating critically ill patients.
The purpose of this prospective multicenter randomized study is to compare successful intubation on the first attempt with the Macintosh videolaryngoscope vs the hyperangulated videolaryngoscope during tracheal intubation in ICU patients.The hypothesis of the study is that tracheal intubation using the hyperangulated videolaryngoscope will improve the frequency of successful intubation on the first attempt in ICU patients requiring intubation in the intensive care unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperangulated videolaryngoscope | Experimental | Tracheal intubation facilitated by a hyperangulated videolaryngoscope |
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| Macintosh videolaryngoscope | Active Comparator | Tracheal intubation facilitated by a videolaryngoscope with a Macintosh type blade |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperangulated blade videolaryngoscope | Device | For patients assigned to the Hyperangulated videolaryngoscope Group, the operator will use a Hyperangulated video laryngoscope on the first laryngoscopy attempt. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the first attempt intubation success rate (percentage) | The primary outcome is defined as placement of an endotracheal tube in the trachea with a single insertion of a videolaryngoscope blade into the mouth and either a single insertion of an endotracheal tube into the mouth or a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube over the bougie into the mouth. | During intubation (minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the overall success rate | To compare the difference overall success rate (percentage) with the two (hyperangulated vs Macintosh blades) videolaryngoscopes | During intubation (minutes) |
| Number of intubation attempts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuel Taboada, Ph.D. | Contact | 678195618 | manutabo@yahoo.es | |
| Manuel Taboada | Contact | 678195618 | manuel.taboada.muniz@sergas.es |
| Name | Affiliation | Role |
|---|---|---|
| Manuel Taboada, Ph.D. | University Clinical Hospital of Santiago de Compostela | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Hospital of Santiago de Compostela | Recruiting | Santiago de Compostela | A Coruña | 15866 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29406182 | Background | Higgs A, McGrath BA, Goddard C, Rangasami J, Suntharalingam G, Gale R, Cook TM; Difficult Airway Society; Intensive Care Society; Faculty of Intensive Care Medicine; Royal College of Anaesthetists. Guidelines for the management of tracheal intubation in critically ill adults. Br J Anaesth. 2018 Feb;120(2):323-352. doi: 10.1016/j.bja.2017.10.021. Epub 2017 Nov 26. | |
| 37326325 |
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Deidentified participant data How to access data: Requests must be sent to manutabo@yahoo.es When available: With publication Additional Information Who can access the data: Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose Mechanisms of data availability: With investigator support
When available: With publication
Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose
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| Macintosh blade videolaryngoscope | Device | For patients assigned to the Macintosh videolaryngoscope Group, the operator will use a Hyperangulated video laryngoscope on the first laryngoscopy attempt. |
|
To compare number of intubations attempts with the two (hyperangulated vs Macintosh blades) videolaryngoscopes
| During intubation (minutes) |
| Modified Cormack-Lehane grade of glottic view | To compare Cormack-Lehane grade of glottic view with the two (hyperangulated vs Macintosh blades) videolaryngoscopes. Modified Cormack-Lehane grade of glottic view is defined as: Grade I: full view of the glottis Grade IIa: partial view of the glottis Grade IIb: arytenoid or posterior part of the vocal cords just visible Grade III: only epiglottis visible Grade IV: neither glottis nor epiglottis visible Cormack-Lehane grade of glottic view | During intubation (minutes) |
| Diference in the incidence of "easy intubation" | To compare the difference in the incidence of "easy intubation" defined as a patient with Cormack-Lehane I-II glottic view and intubation on the first attempt. | During intubation (minutes) |
| Duration of tracheal intubation | To compare the interval (in seconds) between the first insertion of a videolaryngoscope blade into the mouth and the final placement of an endotracheal tube in the trachea. | Duration of procedure (minutes) |
| Reason for unsuccessful intubation on the first attempt | Causes of unsuccessful intubation on the first attempt:
| Duration of procedure (minutes) |
| Number of videolaryngoscopy attempts | To compare the number of videolaryngoscope attempts neccesary to successfull tracheal intubation | Duration of procedure (minutes) |
| Number of attempts to cannulate the trachea with a bougie or an endotracheal tube | To compare the number of attempts to cannulate the trachea with a bougie or an endotracheal tube | Duration of procedure (minutes) |
| Operator-assessed difficulty of intubation | To compare operator-assessed subjective difficulty of intubation:
| Duration of procedure (minutes) |
| Need for additional airway equipment | Airway equipment: bougie, stylet, other videolaryngoscope, others | Duration of procedure (minutes) |
| Need to change the device for intubation | Need to replace by another videolaryngoscope, a different angled blade, requirement for a fiberoptic bronchoscope...). | Duration of procedure (minutes) |
| Complications of tracheal intubation | Complications:
| Duration of procedure (minutes) |
| Complexo Hospitalario Universitario de A Coruña | Recruiting | A Coruña | Spain |
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| Hospital General de Albacete | Not yet recruiting | Albacete | Spain |
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| Hospital de la Santa Creu i Sant Pau, Barcelona | Not yet recruiting | Barcelona | Spain |
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| Hospital Universitario de Cáceres | Not yet recruiting | Cáceres | Spain |
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| Hospital de Denia | Not yet recruiting | Denia | Spain |
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| Hospital General Universitario de Eche | Not yet recruiting | Elche | Spain |
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| Hospital Universitario de Cabueñes, Gijón | Not yet recruiting | Gijón | Spain |
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| Hospital Virgen de las Nieves, Granada | Not yet recruiting | Granada | Spain |
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| Hospital Universitario de Gran Canaria Doctor Negrín | Not yet recruiting | Las Palmas de Gran Canaria | Spain |
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| Complejo Asistencial Universitario de León | Not yet recruiting | León | Spain |
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| Hospital Universitario Lucus Augusti, Lugo | Recruiting | Lugo | Spain |
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| Hospital Gregorio Marañón, Madrid | Not yet recruiting | Madrid | Spain |
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| Hospital Universitario 12 de Octubre, Madrid | Not yet recruiting | Madrid | Spain |
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| Hospital Universitario La Paz, Madrid | Recruiting | Madrid | Spain |
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| Hospital Universitario La Princesa | Not yet recruiting | Madrid | Spain |
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| Hospital Universitario Puerta de Hierro, Majadahonda | Not yet recruiting | Majadahonda | Spain |
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| Hospital Universitario de Móstoles | Not yet recruiting | Móstoles | Spain |
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| Complexo Hospitalario Universitario de Ourense | Not yet recruiting | Ourense | Spain |
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| Hospital Universitario Central de Asturias (HUCA), Oviedo | Not yet recruiting | Oviedo | Spain |
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| Clínica Universidad de Navarra, Pamplona | Not yet recruiting | Pamplona | Spain |
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| Complexo Hospitalario Universitario de Pontevedra | Not yet recruiting | Pontevedra | Spain |
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| Hospital Universitario Donostia, San Sebastián | Recruiting | San Sebastián | Spain |
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| Hospital Universitario Marqués de Valdecilla, Santander | Not yet recruiting | Santander | Spain |
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| Complejo Asistencial de Segovia | Not yet recruiting | Segovia | Spain |
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| Hospital Clínico Universitario de Valencia | Not yet recruiting | Valencia | Spain |
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| Hospital Universitario La Fe de Valencia | Not yet recruiting | Valencia | Spain |
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| Complexo Hospitalario Universitario Álvaro Cunqueiro de Vigo | Not yet recruiting | Vigo | Spain |
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| Hospital Ribera Povisa Vigo | Recruiting | Vigo | Spain |
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| Prekker ME, Driver BE, Trent SA, Resnick-Ault D, Seitz KP, Russell DW, Gaillard JP, Latimer AJ, Ghamande SA, Gibbs KW, Vonderhaar DJ, Whitson MR, Barnes CR, Walco JP, Douglas IS, Krishnamoorthy V, Dagan A, Bastman JJ, Lloyd BD, Gandotra S, Goranson JK, Mitchell SH, White HD, Palakshappa JA, Espinera A, Page DB, Joffe A, Hansen SJ, Hughes CG, George T, Herbert JT, Shapiro NI, Schauer SG, Long BJ, Imhoff B, Wang L, Rhoads JP, Womack KN, Janz DR, Self WH, Rice TW, Ginde AA, Casey JD, Semler MW; DEVICE Investigators and the Pragmatic Critical Care Research Group. Video versus Direct Laryngoscopy for Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2023 Aug 3;389(5):418-429. doi: 10.1056/NEJMoa2301601. Epub 2023 Jun 16. |
| 33755076 | Background | Russotto V, Myatra SN, Laffey JG, Tassistro E, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Pelosi P, Sorbello M, Higgs A, Greif R, Putensen C, Agvald-Ohman C, Chalkias A, Bokums K, Brewster D, Rossi E, Fumagalli R, Pesenti A, Foti G, Bellani G; INTUBE Study Investigators. Intubation Practices and Adverse Peri-intubation Events in Critically Ill Patients From 29 Countries. JAMA. 2021 Mar 23;325(12):1164-1172. doi: 10.1001/jama.2021.1727. |
| 37208282 | Background | Russotto V, Lascarrou JB, Tassistro E, Parotto M, Antolini L, Bauer P, Szuldrzynski K, Camporota L, Putensen C, Pelosi P, Sorbello M, Higgs A, Greif R, Grasselli G, Valsecchi MG, Fumagalli R, Foti G, Caironi P, Bellani G, Laffey JG, Myatra SN; INTUBE Study Investigators. Efficacy and adverse events profile of videolaryngoscopy in critically ill patients: subanalysis of the INTUBE study. Br J Anaesth. 2023 Sep;131(3):607-616. doi: 10.1016/j.bja.2023.04.022. Epub 2023 May 17. |
| 35820934 | Background | Hansel J, Rogers AM, Lewis SR, Cook TM, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adults undergoing tracheal intubation: a Cochrane systematic review and meta-analysis update. Br J Anaesth. 2022 Oct;129(4):612-623. doi: 10.1016/j.bja.2022.05.027. Epub 2022 Jul 9. |
| 38167459 | Background | Araujo B, Rivera A, Martins S, Abreu R, Cassa P, Silva M, Gallo de Moraes A. Video versus direct laryngoscopy in critically ill patients: an updated systematic review and meta-analysis of randomized controlled trials. Crit Care. 2024 Jan 2;28(1):1. doi: 10.1186/s13054-023-04727-9. |
| 29787386 | Result | Taboada M, Doldan P, Calvo A, Almeida X, Ferreiroa E, Baluja A, Carinena A, Otero P, Caruezo V, Naveira A, Otero P, Alvarez J. Comparison of Tracheal Intubation Conditions in Operating Room and Intensive Care Unit: A Prospective, Observational Study. Anesthesiology. 2018 Aug;129(2):321-328. doi: 10.1097/ALN.0000000000002269. |
| 39237284 | Derived | Taboada M, Estany-Gestal A, Fernandez J, Vazquez O, Pajares A, Ramasco F, Martinez S, Vallejo I, Perez A, Rama-Maceiras P, Bermudez M, Power M, Garcia-Alvarez R, Fernandez-Villa I, Aguilera JL, Carrio M, Cabadas R, Rubin A, Williams MM, Fernandez-Garcia R, Becerra A, Gine M, Garcia FJ, Iglesias MC, Santamarina RM, Del Valle S, Charco LM, Alonso MC, Rodriguez IM, Varela M, Hermoso JI, Vives M, Cabaleiro T. Hyperangulated versus Macintosh blades for intubation with videolaryngoscopy in ICU: the randomised multicentre INVIBLADE-ICU trial study protocol. BMJ Open. 2024 Sep 5;14(9):e086691. doi: 10.1136/bmjopen-2024-086691. |