Innovative Endotracheal Tube Design Reduces Postoperative Laryngeal Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Laryngeal injury
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective perianal surgery requiring intubation for general anesthesia
- •Duration range 30-90 minutes
排除标准
- •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.
结局指标
主要结局
Laryngeal injury
时间窗: 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
次要结局
- Postoperative cough(45 minutes after the end of the procedure)
- Bucking during extubation(During extubation)
- Acoustic Voice Quality Index 03.01 (AVQIv3)(Immediately before the induction and 45 minutes after the end of the procedure)
- Acoustic Breathiness Index (ABI)(Immediately before the induction and 45 minutes after the end of the procedure)
研究者
Pedro Luis Bravo
Director
University Hospital of the Nuestra Señora de Candelaria