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The goal of this randomized clinical trial is to compare two different orotracheal tubes in patients which require orotracheal intubation for general anesthesia. The main questions it aims to answer are:
Participants will be randomly assigned into two groups, one will use conventional endotracheal tube and the other will use Triglotix® endotracheal tube.
Endotracheal intubation is necessary in some patients undergoing surgical procedures and patients requiring mechanical ventilation in the intensive care unit. However, endotracheal intubation is associated with known complications. In post-surgical patients subjected to orotracheal intubation, the incidence of dysphagia, sore throat, hoarseness and cough is 43%,38%27%,32% respectivelly. These figures increase in cases of prolonged intubation, such as those in intensive care units, where reported rates are 76% for sore throat, 63% for hoarseness and 49% for dysphagia. No significant endotracheal tube design improvements have been developed over the past few decades addressing these issues.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETT-T | Experimental | Endotracheal tube Triglotix® |
|
| ETT-C | Active Comparator | Endotracheal tube conventional |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triglotix® | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Laryngeal injury | Laryngeal pathology was assessed based on the location (unilateral: right/left or bilateral) and on morphology: grade 0 = no lesions, grade 1 = superficial erythema (redness of the mucosa without surrounding inflammation), grade 2 = oedema (swollen mucosa at the vocal cords), grade 3 haematoma (redness of the mucosa with surrounding inflammatory swelling), grade 4 = mucosal laceration (causing active bleeding into the vocal cords), grade 5 = arytenoid dislocation or subluxation (arytenoid with limited movement), and grade 6 = vocal cord palsy | Immediately before the induction and 45 minutes after the end of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative cough | Postoperative cough was assessed: (0 = None, 1 = mild cough, 2 = moderate cough <5 s, 3 = Severe cough >5 s) | 45 minutes after the end of the procedure |
| Bucking during extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Bravo, MD | University Hospital of the Nuestra Señora de Candelaria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pedro Luis Bravo | Santa Cruz de Tenerife | 38001 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22431870 | Background | 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. | |
| 23622939 | Background | 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. |
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Data to be shared: all IPD that underlie results in a publication
Available six months after the end of the analysis.
Main investigator is the contact for review requests
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| ID | Term |
|---|---|
| D006685 | Hoarseness |
| D003371 | Cough |
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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|
|
| Conventional endotracheal tube | Device | Conventional endotracheal tube that is currently used worldwide |
|
|
Presence of bucking during extubation assessed by the anesthesiologist just after stimulating the patient (1 = mild, 2 = severe, 3 = abscense)
| During extubation |
| Acoustic Voice Quality Index 03.01 (AVQIv3) | Concatenated voice samples of 3 seconds of sv [a:] and voiced segments of a phonetically balanced text. | Immediately before the induction and 45 minutes after the end of the procedure |
| Acoustic Breathiness Index (ABI) | Concatenated voice samples of 3 seconds of sv [a:] and voiced segments of a phonetically balanced text. | Immediately before the induction and 45 minutes after the end of the procedure |
| 33196479 | Background | 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. |
| 30096101 | Background | 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. |
| 6423162 | Background | 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. |
| 29490478 | Background | 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. |
| 12717124 | Background | 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. |
| 2661158 | Background | 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. |
| 6625441 | Background | 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. |
| 12434607 | Result | 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. |
| 39418198 | Derived | 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. |
| D010038 |
| Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |