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Laryngeal InjuryTriglotix®NCT06108271

Innovative Endotracheal Tube Design Reduces Postoperative Laryngeal Injury

A study testing Triglotix® and Conventional endotracheal tube in people with Laryngeal Injury and Hoarseness, run by University Hospital of the Nuestra Señora de Candelaria at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Laryngeal Injury, Hoarseness, Cough
What is being tested?
Triglotix® and Conventional endotracheal tube
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteSpain
Study dates
1 Oct 2023to 15 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Pedro Luis Bravo

    Santa Cruz de Tenerife, 38001

Other trials in Spain

About this study

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.

Read the detailed description

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.

Being tested
Triglotix®, Conventional endotracheal tube
Keywords
Laryngeal Injury, Endotracheal tube, General anesthesia
Medical subject headings
Hoarseness, Cough, Pharyngitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Triglotix®Device

    Also called ETT-T

    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 tubeDevice

    Also called ETT-C

    Conventional endotracheal tube that is currently used worldwide

Study groups in NCT06108271
Study groupRoleWhat they receive
ETT-TExperimentalEndotracheal tube Triglotix®
Receives: Device: Triglotix®
ETT-CActive comparatorEndotracheal tube conventional
Receives: Device: Conventional endotracheal tube

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (4)

  1. Postoperative cough

    Postoperative cough was assessed: (0 = None, 1 = mild cough, 2 = moderate cough <5 s, 3 = Severe cough >5 s)

    Measured: 45 minutes after the end of the procedure

  2. Bucking during extubation

    Presence of bucking during extubation assessed by the anesthesiologist just after stimulating the patient (1 = mild, 2 = severe, 3 = abscense)

    Measured: During extubation

  3. Acoustic Voice Quality Index 03.01 (AVQIv3)

    Concatenated voice samples of 3 seconds of sv [a:] and voiced segments of a phonetically balanced text.

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

  4. Acoustic Breathiness Index (ABI)

    Concatenated voice samples of 3 seconds of sv [a:] and voiced segments of a phonetically balanced text.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start1 Oct 2023
  3. Primary completion1 Nov 2023 (estimated)
  4. Study completion15 Nov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06108271
Sponsor's protocol ID
Endotracheal tube Triglotix®
Acronym
Triglotix®
Status last verified
Oct 2023
First submitted
27 Sep 2023
Last updated
30 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data to be shared: all IPD that underlie results in a publication

Publications

  • 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.

    PubMed 22431870

  • 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.

    PubMed 23622939

  • 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.

    PubMed 33196479

  • 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.

    PubMed 30096101

  • 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.

    PubMed 6423162

  • 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.

    PubMed 29490478

  • 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.

    PubMed 12717124

  • 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.

    PubMed 2661158

  • 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.

    PubMed 6625441

  • 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.

    PubMed 12434607

  • 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.

    PubMed 39418198

Questions about this trial

What is this clinical trial studying?

A study testing Triglotix® and Conventional endotracheal tube in people with Laryngeal Injury and Hoarseness, run by University Hospital of the Nuestra Señora de Candelaria at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Laryngeal injury (time frame: Immediately before the induction and 45 minutes after the end of the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06108271, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.

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