An interventional study of Triglotix® and Conventional endotracheal tube in Laryngeal Injury, Hoarseness and Cough, sponsored by University Hospital of the Nuestra Señora de Candelaria. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-30.
Sponsored by University Hospital of the Nuestra Señora de Candelaria · Not applicable, Interventional, and Prevention
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.
52 studies on the registry are indexed under Hoarseness; 9 are open to participants now.
This study's planned enrollment of 68 is below the median of 108 across 44 interventional studies indexed under Hoarseness.
Browse Hoarseness studies →University Hospital of the Nuestra Señora de Candelaria is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Endotracheal tube Triglotix®
Device: Triglotix®
Endotracheal tube conventional
Device: Conventional endotracheal tube
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
Conventional endotracheal tube that is currently used worldwide
Also known as: ETT-C
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
Time frame: Immediately before the induction and 45 minutes after the end of the procedure
Postoperative cough
Postoperative cough was assessed: (0 = None, 1 = mild cough, 2 = moderate cough \<5 s, 3 = Severe cough \>5 s)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Immediately before the induction and 45 minutes after the end of the procedure
Plan to share: Yes — Data to be shared: all IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Available six months after the end of the analysis.
Access criteria: Main investigator is the contact for review requests
This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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University Hospital of the Nuestra Señora de Candelaria