"Comparison of Two Methods of Securing Endotracheal Tubes in Intensive Care : Elastic Adhesive Strips vs Lace In A Protective Sheath. A Randomized Multicenter, Cluster and Crossover Controlled Study. FIXATUB"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 768
- 试验地点
- 13
- 主要终点
- Peribuccal lesion
研究概览
简要总结
Every year, in France, nearly 100,000 patients hospitalized in intensive care more than 48 hours require invasive respiratory assistance via an endotracheal tube.
Appropriate tube fixation is essential to ensure effective ventilation while minimizing potential complications such as accidental extubations. However, the fixation system chosen may lead to peribuccal lesions such as bedsores, shearing or cutaneous-mucous tear. These lesions are painful for patients and often unsightly as scar may remain.
There are no formal recommendations for the use of any type of fixing system. Thus, systems used to secure the endotracheal tube vary from one ICU to another.
The objective of this study is to demonstrate that the fixing strategy by elastic adhesive tape reduces the risk of developing a peribuccal lesion during the time of the endotracheal tube's maintenance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient hospitalized in Intensive Care Unit
- •Age over 18
- •Intubation for estimated duration > 48h
- •Patient treated with vasopressors
- •Patient or relative who received the information and are not opposed to study participation or patient included under the emergency procedure in the absence of contactable family members.
排除标准
- •Pre-existing face lesions at ICU admission along the path of the endotracheal tube fixing.
- •Admitted patient already intubated upon transfer from another ICU
- •Nasotracheal intubation
- •Patient in isolation for suspected COVID or clinically proven COVID
- •Admitted tracheotomized patient
- •Pregnant, nursing, parturient woman
- •Lack of social security affiliation
- •Incapable major (under guardianship, curatorship)
- •Patient deprived of liberty by court order
研究组 & 干预措施
Elastic Adhesive Strips
Endotracheal tube fixed by elastic adhesive tape (Tensoplast type adhesive tape):
The adhesive tape will be attached to the patient's face (opposite side to the endotracheal tube) and then two turns around the endotracheal tube will be made. The rest of the adhesive tape will be attached to the other side of the face (side of the endotracheal tube).
The laminated tape will be kept on the adhesive tape until it passes over the neck in order to avoid adhering to the hair.
Finally, the end of the adhesive tape will be replaced on the part already attached to the patient.
It will be changed daily and after stain or examinations if necessary.
干预措施: Elastic Adhesive Strips (Device)
Lace in A Protective Sheath
A loop is made with the lace then the endotracheal tube is passed through the loop. The loop is tightened by pulling each side on the remaining cords and a knot is made on one side of the fastener.
It will be changed daily and after stain or examinations if necessary.
干预措施: Lace in A Protective Sheath (Device)
结局指标
主要结局
Peribuccal lesion
时间窗: up to 10 days after intubation
Appearance of at least one peribuccal lesion during the first 10 days of maintaining the endotracheal tube inserted orally. Presence of peribuccal lesion will be validated on picture by an independent review committee. The picture will be taken daily without the visible fixing system (blind maintained for the adjudication committee) from J0 to J10 at the site of the endotracheal tube.
次要结局
未报告次要终点