Clinical trial NCT06108271: Innovative Endotracheal Tube Design Reduces Postoperative Laryngeal Injury
Official title: Innovative Endotracheal Tube Design Reduces Postoperative Laryngeal Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Laryngeal Injury
Hoarseness
Cough
Sore-throat
Intubation Complication
Bucking, Anesthesia Related
Keywords: Laryngeal Injury
Endotracheal tube
General anesthesia
Lead sponsor: University Hospital of the Nuestra Señora de Candelaria
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Laryngeal injury
timeFrame: Immediately before the induction and 45 minutes after the end of the procedure
Secondary outcomes:
measure: Postoperative cough
timeFrame: 45 minutes after the end of the procedure
measure: Bucking during extubation
timeFrame: During extubation
measure: Acoustic Voice Quality Index 03.01 (AVQIv3)
timeFrame: Immediately before the induction and 45 minutes after the end of the procedure
measure: Acoustic Breathiness Index (ABI)
timeFrame: Immediately before the induction and 45 minutes after the end of the procedure
Other outcomes:
Locations:
city: Santa Cruz De Tenerife
country: Spain
facility: Pedro Luis Bravo
Study officials:
affiliation: University Hospital of the Nuestra Señora de Candelaria
name: Pedro Bravo, MD
role: PRINCIPAL_INVESTIGATOR
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