Innovative Endotracheal Tube Design Reduces Postoperative Laryngeal Injury
NCT ID: NCT06108271
Last Updated: 2023-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
68 participants
INTERVENTIONAL
2023-10-01
2023-11-15
Brief Summary
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* To assess the presence of laryngeal injury
* To evaluate the consequences in voice quality
* To ask for the presence of symptoms as sore throat, hoarseness, and cough
Participants will be randomly assigned into two groups, one will use conventional endotracheal tube and the other will use Triglotix® endotracheal tube.
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Detailed Description
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The present study aims to compare the incidence of laryngeal injuries, and related symptoms as sore throat, hoarseness, swallowing problems, bucking and coughing between two defined sample populations: those utilizing a conventional endotracheal tube (ETT-C) and those employing the new Triglotix® endotracheal tube (ETT-T) in patients undergoing elective surgery requiring general anesthesia and mechanical ventilation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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ETT-T
Endotracheal tube Triglotix®
Triglotix®
The Triglotix® has a biocompatible self-expanding viscoelastic cuff that is located in the supraglottic, glottic and subglottic space. This cuff separates the endotracheal tube from the laryngeal vestibule in the supraglottic space and the vocal cords avoiding direct tissue damage from the plastic components of the tube. The viscoelastic cuff self-expands after the endotracheal tube is in adequate position in the airway. Then it adapts progressively and gradually to the shape of structures it comes in contact with, applying minimal pressure to the surrounding tissue. The ETT-T also has two wire reinforced segments: the first is located outside the mouth to prevent deformation related with kinking, while the second segment is positioned distally along the larynx. The primary purpose of this design is to mitigate torsional, rotational and lateralization forces that the tube may encounter while the patient is intubated.
ETT-C
Endotracheal tube conventional
Conventional endotracheal tube
Conventional endotracheal tube that is currently used worldwide
Interventions
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Triglotix®
The Triglotix® has a biocompatible self-expanding viscoelastic cuff that is located in the supraglottic, glottic and subglottic space. This cuff separates the endotracheal tube from the laryngeal vestibule in the supraglottic space and the vocal cords avoiding direct tissue damage from the plastic components of the tube. The viscoelastic cuff self-expands after the endotracheal tube is in adequate position in the airway. Then it adapts progressively and gradually to the shape of structures it comes in contact with, applying minimal pressure to the surrounding tissue. The ETT-T also has two wire reinforced segments: the first is located outside the mouth to prevent deformation related with kinking, while the second segment is positioned distally along the larynx. The primary purpose of this design is to mitigate torsional, rotational and lateralization forces that the tube may encounter while the patient is intubated.
Conventional endotracheal tube
Conventional endotracheal tube that is currently used worldwide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Duration range 30-90 minutes
Exclusion Criteria
* American Society of Anesthesiologists physical status (ASA) \> III
* Morbid obesity (body mass index \>40 kg/m2)
* Patients not suitable for outpatient surgery
* Patients with history of previous neck surgery
* Patients with history of dysphagia
* Patients with comorbidities as diabetes and hypertension.
18 Years
70 Years
ALL
Yes
Sponsors
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University Hospital of the Nuestra Señora de Candelaria
OTHER
Responsible Party
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Pedro Luis Bravo
Director
Principal Investigators
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Pedro Bravo, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of the Nuestra Señora de Candelaria
Locations
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Pedro Luis Bravo
Santa Cruz de Tenerife, , Spain
Countries
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References
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Mendels EJ, Brunings JW, Hamaekers AE, Stokroos RJ, Kremer B, Baijens LW. Adverse laryngeal effects following short-term general anesthesia: a systematic review. Arch Otolaryngol Head Neck Surg. 2012 Mar;138(3):257-64. doi: 10.1001/archoto.2011.1427.
Melsen WG, Rovers MM, Groenwold RH, Bergmans DC, Camus C, Bauer TT, Hanisch EW, Klarin B, Koeman M, Krueger WA, Lacherade JC, Lorente L, Memish ZA, Morrow LE, Nardi G, van Nieuwenhoven CA, O'Keefe GE, Nakos G, Scannapieco FA, Seguin P, Staudinger T, Topeli A, Ferrer M, Bonten MJ. Attributable mortality of ventilator-associated pneumonia: a meta-analysis of individual patient data from randomised prevention studies. Lancet Infect Dis. 2013 Aug;13(8):665-71. doi: 10.1016/S1473-3099(13)70081-1. Epub 2013 Apr 25.
Brodsky MB, Akst LM, Jedlanek E, Pandian V, Blackford B, Price C, Cole G, Mendez-Tellez PA, Hillel AT, Best SR, Levy MJ. Laryngeal Injury and Upper Airway Symptoms After Endotracheal Intubation During Surgery: A Systematic Review and Meta-analysis. Anesth Analg. 2021 Apr 1;132(4):1023-1032. doi: 10.1213/ANE.0000000000005276.
Brodsky MB, Levy MJ, Jedlanek E, Pandian V, Blackford B, Price C, Cole G, Hillel AT, Best SR, Akst LM. Laryngeal Injury and Upper Airway Symptoms After Oral Endotracheal Intubation With Mechanical Ventilation During Critical Care: A Systematic Review. Crit Care Med. 2018 Dec;46(12):2010-2017. doi: 10.1097/CCM.0000000000003368.
Seegobin RD, van Hasselt GL. Endotracheal cuff pressure and tracheal mucosal blood flow: endoscopic study of effects of four large volume cuffs. Br Med J (Clin Res Ed). 1984 Mar 31;288(6422):965-8. doi: 10.1136/bmj.288.6422.965.
Delgado Hernandez J, Leon Gomez NM, Jimenez A, Izquierdo LM, Barsties V Latoszek B. Validation of the Acoustic Voice Quality Index Version 03.01 and the Acoustic Breathiness Index in the Spanish language. Ann Otol Rhinol Laryngol. 2018 May;127(5):317-326. doi: 10.1177/0003489418761096. Epub 2018 Feb 28.
Mencke T, Echternach M, Kleinschmidt S, Lux P, Barth V, Plinkert PK, Fuchs-Buder T. Laryngeal morbidity and quality of tracheal intubation: a randomized controlled trial. Anesthesiology. 2003 May;98(5):1049-56. doi: 10.1097/00000542-200305000-00005.
Bishop MJ. Mechanisms of laryngotracheal injury following prolonged tracheal intubation. Chest. 1989 Jul;96(1):185-6. doi: 10.1378/chest.96.1.185. No abstract available.
Weymuller EA Jr, Bishop MJ, Fink BR, Hibbard AW, Spelman FA. Quantification of intralaryngeal pressure exerted by endotracheal tubes. Ann Otol Rhinol Laryngol. 1983 Sep-Oct;92(5 Pt 1):444-7. doi: 10.1177/000348948309200506.
Sajedi P, Maaroffi V. The macroscopic changes of tracheal mucosa following tight versus loose control of tracheal tube cuff pressure. Acta Anaesthesiol Sin. 2002 Sep;40(3):117-20.
Bravo PL, Gonzalez Sammarco F, Cueva Nieves DA, Lorente L, Delgado J, Martinez-Ruiz R. Innovative Endotracheal Tube Design Reduces Laryngeal Injury with an Excellent Airway Seal and Minimal Cuff Pressures. Anesth Analg. 2025 Apr 1;140(4):983-985. doi: 10.1213/ANE.0000000000007260. Epub 2024 Oct 17. No abstract available.
Other Identifiers
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Endotracheal tube Triglotix®
Identifier Type: -
Identifier Source: org_study_id
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