Innovative Endotracheal Tube Design Reduces Postoperative Laryngeal Injury

Not Applicable

Active, not recruiting

• Conditions: Bucking, Anesthesia Related; Sore-throat; Laryngeal Injury; Intubation Complication; Hoarseness; Cough
• Interventions: Device: Conventional endotracheal tube; Device: Triglotix®

• Registration Number: NCT06108271
• Lead Sponsor: University Hospital of the Nuestra Señora de Candelaria

Brief 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 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

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 Timeline

• Study First Submitted: 2023-09-27
• Status Verified: 2023-10
• Study Start: 2023-10-01
• Study First Submitted QC: 2023-10-28
• Last Update Submitted: 2023-10-28
• Study First Posted: 2023-10-30
• Last Update Posted: 2023-10-30
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ETT-C	Conventional endotracheal tube	Endotracheal tube conventional
ETT-T	Triglotix®	Endotracheal tube Triglotix®

Primary Outcome Measures

Name	Time	Method
Laryngeal injury	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

Secondary Outcome Measures

Name	Time	Method
Postoperative cough	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)
Bucking during extubation	During extubation	Presence of bucking during extubation assessed by the anesthesiologist just after stimulating the patient (1 = mild, 2 = severe, 3 = abscense)
Acoustic Voice Quality Index 03.01 (AVQIv3)	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.
Acoustic Breathiness Index (ABI)	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.

Trial Locations

Locations (1)

Pedro Luis Bravo; 🇪🇸 Santa Cruz De Tenerife, Spain