Innovative Endotracheal Tube Design Reduces Postoperative Laryngeal Injury (Triglotix®)

October 28, 2023 updated by: Pedro Luis Bravo, University Hospital of the Nuestra Señora de Candelaria

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Santa Cruz De Tenerife, Spain, 38001
        • Pedro Luis Bravo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ETT-T
Endotracheal tube Triglotix®
Device: Triglotix®
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.
Other Names:
  • ETT-T
Active Comparator: ETT-C
Endotracheal tube conventional
Device: Conventional endotracheal tube
Conventional endotracheal tube that is currently used worldwide
Other Names:
  • ETT-C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laryngeal injury
Time Frame: Immediately before the induction and 45 minutes after the end of the procedure
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
Time Frame: 45 minutes after the end of the procedure
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
Time Frame: 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)
Time Frame: Immediately before the induction and 45 minutes after the end of the procedure
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)
Time Frame: Immediately before the induction and 45 minutes after the end of the procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of the Nuestra Señora de Candelaria

Investigators

  • Principal Investigator: Pedro Bravo, MD, University Hospital of the Nuestra Señora de Candelaria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

November 15, 2023

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

October 28, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 28, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Endotracheal tube Triglotix®

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data to be shared: all IPD that underlie results in a publication

IPD Sharing Time Frame

Available six months after the end of the analysis.

IPD Sharing Access Criteria

Main investigator is the contact for review requests

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cough

Clinical Trials on Triglotix®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe