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

University Hospital of the Nuestra Señora de Candelaria

Status: Active, not recruiting

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

Treatments: Device: Conventional endotracheal tube; Device: Triglotix®

Study type: Interventional

Funder types: Other

Identifiers

NCT06108271

Endotracheal tube Triglotix®

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups

ETT-T

Experimental group

Description:

Endotracheal tube Triglotix®

Treatment:

Device: Triglotix®

ETT-C

Active Comparator group

Description:

Endotracheal tube conventional

Treatment:

Device: Conventional endotracheal tube