Innovative Endotracheal Tube Design Reduces Postoperative Laryngeal Injury

NCT06108271 | Unknown DMC

• 1 other identifier: Endotracheal tube Triglotix®
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Laryngeal Injury; Hoarseness; Cough; Sore-throat; Intubation Complication; Bucking, Anesthesia Related

Keywords

Laryngeal Injury; Endotracheal tube; General anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Postoperative cough

  45 minutes after the end of the procedure

• Bucking during extubation

  During extubation

• Acoustic Voice Quality Index 03.01 (AVQIv3)

  Immediately before the induction and 45 minutes after the end of the procedure

• Acoustic Breathiness Index (ABI)

  Immediately before the induction and 45 minutes after the end of the procedure

Study Arms (2)

ETT-T

EXPERIMENTAL

Endotracheal tube Triglotix®

Device: Triglotix®

ETT-C

ACTIVE COMPARATOR

Endotracheal tube conventional

Device: Conventional endotracheal tube

Interventions

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.

Also known as: ETT-T

ETT-T

Conventional endotracheal tube DEVICE

Conventional endotracheal tube that is currently used worldwide

Also known as: ETT-C

ETT-C

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective perianal surgery requiring intubation for general anesthesia
• Duration range 30-90 minutes

You may not qualify if:

• Difficult airway
• 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.

Sponsors & Collaborators

• University Hospital of the Nuestra Señora de Candelaria: lead

Study Sites (1)

Pedro Luis Bravo

Santa Cruz de Tenerife, 38001, Spain

Location

Related Publications (11)

• 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.

  PMID: 22431870 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.

  PMID: 23622939 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.

  PMID: 33196479 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.

  PMID: 30096101 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.

  PMID: 6423162 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.

  PMID: 29490478 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.

  PMID: 12717124 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.

  PMID: 2661158 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.

  PMID: 6625441 BACKGROUND

• 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.

  PMID: 12434607 RESULT

• 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.

  PMID: 39418198 DERIVED

MeSH Terms

Conditions

Hoarseness; Cough; Pharyngitis

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases

Study Officials

• Pedro Bravo, MD

  University Hospital of the Nuestra Señora de Candelaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 30, 2023
• Study Start: October 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 15, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Available six months after the end of the analysis.
• Access Criteria: Main investigator is the contact for review requests

Locations

ES (1)