A Prospective, Multicenter, Randomized and Single Bind Trial. Influence of Laryngoscope Blade Material on Postoperative PHARYNGEAL AND LARYNGEAL Morbidity Following Scheduled OroTracheal Intubation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 712
- 试验地点
- 2
- 主要终点
- The frequency of patients presenting a post-operative sore throat whose intensity is above 4 on a visual analogue scale (VAS) graded from 0 (no pain) to 10 (unbearable pain) collected at the discharge of the post-anesthesia care unit (PACU).
研究概览
简要总结
Orotracheal intubation following general anesthesia requires blades to be performed. The risk of patients contamination with infectious agents related to reusable metal blades leads to promote single-use blades. Some of these latter are plastic and this material may need more strength to lift the jaw and expose the larynx before orotracheal intubation. Sometimes, change of blade, from plastic to metal, during the procedure is necessary to increase the larynx exposure. This change of blade may increase the frequency of sore throat following orotracheal intubation.
Consequently, the study hypothesis is an increase of both sore throat intensity and frequency with the plastic blades compared with the metal blades.
The primary purpose of the present study is to compare the impact of these two types of blades, metal versus plastic, on sore throat intensity and frequency following scheduled orotracheal intubation for general anesthesia
详细描述
Trial design :
This will be a multicenter, prospective, randomized and single-blind controlled study
Material and Methods :
The obtaining of the Ethic Committee approval allows the enrolment of 712 patients scheduled for surgery performed under general anesthesia with orotracheal intubation. Adult patients, 18 to 70 years-old, with grade I-II of ASA (American Society of Anesthesiology) status will be enrolled after clear information and obtaining, at the anesthesia visit, of the non-opposition to be enrolled in the trial.
At the anesthesia visit, the anesthesiologist will explain the purpose and protocol to the patients and then will propose them to participate to the study. The decision to be enrolled will be known at the pre-anesthesia visit, one day before the surgery. Therefore, the patients will have a delay between the anesthesia and pre-anesthesia visits to make a decision. The non-opposition to participate to the trial will be clearly mentioned in the medical file.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
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
- •Adult patient, 18-70 years-old scheduled for surgery planned under general anesthesia with orotracheal intubation
- •Patient who has underwent a clinical examination before inclusion
- •Patient who has carefully read the information notice and is not opposed to participate to the study
- •Patient having a assurance policy or a similar regimen
排除标准
- •Pregnancy
- •Difficulty to understand the current language (French)
- •Presence of predictive factors of difficult orotracheal intubation
- •Previous difficult tracheal intubation Grade IV of the MALLANPETI score Limited mouth opening (inter-incisive distance < 3.5 cm) Limited cervical mobility Thyromental distance < 6 cm History of radiotherapy or surgery for ENT cancer Retrognathism Presence of gastric tube for postoperative purposes Presence of Pharyngeal and Laryngeal signs before surgery
- •Type of surgery Surgery performed without orotracheal intubation Thyroid surgery ENT surgery Withdrawal of gastric banding Bariatric surgery Ambulatory surgery (one-day surgery)
结局指标
主要结局
The frequency of patients presenting a post-operative sore throat whose intensity is above 4 on a visual analogue scale (VAS) graded from 0 (no pain) to 10 (unbearable pain) collected at the discharge of the post-anesthesia care unit (PACU).
时间窗: Two years
次要结局
- the tracheal intubation duration.(one day)
- dental injuries(seven days)
- blood on the blade(seven days)
- The frequency of patients presenting a post-operative sore throat whose intensity is different from 0/10 without swallowing(2 years)
- The pain intensity will be measured at the discharge of the post-anesthesia care unit (PACU) with a slide ruler displaying a visual analogue scale graded from 0 (no pain) to 10 (unbearable pain) on the blinded face(seven days)
- the degree of voice modification on a VAS(Seven days)
- the sore throat VAS during swallowing.(seven days)
- jaw pain(seven days)
- lips injuries(seven days)
- the intubation difficulty score (IDS)(one day)
- the frequency of difficult intubation(Two years)
- the frequency of change of blade during the tracheal intubation procedure(two years)