Innovative Endotracheal Tube Design Reduces Postoperative Laryngeal Injury

Study Overview
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Brief Summary
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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: 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.

Detailed Description
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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.

Official Title
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Innovative Endotracheal Tube Design Reduces Postoperative Laryngeal Injury

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

Intervention / Treatment
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* Device: Triglotix®
* Device: Conventional endotracheal tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective perianal surgery requiring intubation for general anesthesia Duration range 30-90 minutes Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ETT-T<br>Endotracheal tube Triglotix® | Device: Triglotix®<br>* 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.<br>* Other names: ETT-T;|
| Active Comparator: ETT-C<br>Endotracheal tube conventional | Device: Conventional endotracheal tube<br>* Conventional endotracheal tube that is currently used worldwide<br>* Other names: ETT-C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngeal Injury, Endotracheal tube, General anesthesia