Evaluation of Laryngeal Morbidity After Orotracheal Intubation by Vocal Analysis and Laryngostroboscopy: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Incidence, expressed as the number of new cases per year, of laryngeal complications arising after endotracheal intubation. This complications will be related to:
研究概览
简要总结
The delicate structures of the larynx can be compromised by innumerable causes, one of these is represented by endotracheal intubation. More frequently, these damages are represented by hematomas, edema and granulomas of the vocal cords. The pathophysiology of laryngeal damage can be explained by an ischemic attack of the chordal mucosa. Numerous risk factors can cause the onset of damage, some depending on the practice itself, such as size and type of endotracheal tube, cuff pressure, use of mandrels and / or inserting devices, use of oral or nasogastric tubes, use of neuromuscular inhibitors or sleep-inducing drugs and the duration of the intervention; others from patient-related factors, such as gender, weight, history of exposure of smoking habit, or a history of gastroesophageal reflux (GERD). The incidence of such symptoms varies from 0% to 18% among the general population, with an average of 6% with resolution of most of the symptoms within 72 hours unless substantial damage has occurred to the vocal cords or to the arytenoids. In general, the incidence of such laryngeal complications has been described by several studies, but there is no standardized protocol for measuring and evaluating their entity. The purpose of this study is to determine how the voice and the chordal clinical aspect vary after oro-tracheal intubation, evaluated through voice analysis and laryngostroboscopy.
详细描述
Acoustic analysis aims at studying the acoustic emission of the pneumo-phono-articulatory system, i.e. the vocal signal. Currently, digital technology instruments enable the processing and analysis of the verbal signal quickly and reliably, also offering graphical products and numerical data. Among the various existing software products for the study of the vocal signal, PRAAT is available.
In practice, the vocal parameters are acquired in a non-invasive way with a microphone. At the same time, these analysis systems can be integrated by other methods, such as laryngostroboscopy. This method is one of the most widely used techniques for laryngeal clinical evaluation. This is a non-invasive endoscopic practice performed by means of a flexible fibroscope, which, through a pulsed light source, allows visualization of the chordal movement.
At first, a study will be carried out on healthy volunteers, comparable for their demographic characteristics to the second population to be included. In this way the investigators will test the instrument used for the voice analysis, in order to set the reference values for the general population. In a second step, the investigators will evaluate the incidence of post-intubation laryngeal complications, considering as a pathological all values above 95% percentile compared to healthy individuals.
During the first phase, healthy volunteers will undergo voice analysis in two different days. Subsequently, the patients included in the study population will be undergo during the preoperative, intraoperative and postoperative to a combined evaluation between Anesthesiologists and ENTs for data collection.
The data to be recorded, both for the healthy volunteers as well as for patients, will include personal data, anamnestic, working exposure and specific risk factors such as smoking, alcohol, irritants, a previous diagnosis of GERD, frequent inflammation of upper respiratory tract (VADS); moreover, only for patients, the pre-, intra and post-surgery anesthesia evaluation parameters will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •all patients between the age of 18 and 70 years old who have given informed consent and who must undergo general or urological surgery will be included.
排除标准
- •age: below 18 or over 70 years old,
- •refusal of the patient to consent,
- •risk of the American Society Anesthesiologists (ASA) > III,
- •patients previously subjected to demolition surgery of head-neck and/or chemo-radiotherapy of the same structures,
- •patients with a history of hoarseness, vocal tract abnormalities and / or hearing impairment.
结局指标
主要结局
Incidence, expressed as the number of new cases per year, of laryngeal complications arising after endotracheal intubation. This complications will be related to:
时间窗: Presence of laryngeal damage 24-48 hours after surgery not visible at the pre-surgery visit.
1. the variation of voice parameters, during acoustic analysis, above 95% percentile, compared to healthy volunteers, of patients who undergo orotracheal intubation. 2. the presence or absence of laryngeal damage at laryngostroboscopy.
次要结局
- Correlation between endotracheal tube size and presence of laryngeal damage(The data will be assessed 24 hours after surgery)
- Correlation between use or not of mandrel and the modifications of Jitter %(The data will be assessed 24 hours after surgery)
- Correlation between weight and modified Mallampati(The data will be assessed during pre-surgery visit)
- Correlation between use or not of mandrel and the modifications of Shimmer %(The data will be assessed 24 hours after surgery)
研究者
Rosanna Vaschetto, MD, PhD
medical physician
Azienda Ospedaliero Universitaria Maggiore della Carita