Clinical and Economic Comparison of 2 Methods of Intubation Tube Fixation in the Intensive Care Unit: Benefits of Intubation Tube Fixation With AnchorFastTM Versus Current Cord Fixation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Hopital Foch
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Comparison of induced pressure sores
研究概览
简要总结
The aim of this study is to assess the benefits of using the Anchorfast device in reducing complications associated with intubation tube fixation, in terms of the rate of pressure ulcer development, the rate of intubation tube mobilization and the rate of VAP occurrence. If the hypothesis is confirmed, this project would enable the caregivers to optimize the current practice in the interests of both patients and caregivers. That's why the investigators have designed a real-life study, and will also be looking at the effect of care load on and caregiver satisfaction.
详细描述
In 2022 at Hôpital FOCH, 41% of patients admitted to the intensive care unit required an orotracheal intubation tube (OIT), exposing them to the risk of developing orotracheal intubation tube (OIT), exposing them to the risk of developing ventilator-associated pneumonia (VAP).
Preventing VAP involves oral hygiene and limiting tube movements, which depend on the device used to attach the OIT . The care protocol used routinely in the department uses adhesive tape and a rigid cotton haberdashery cord. This type of fixation impedes buccal access, prevents easy repositioning of the probe and is liable to cause eschar lesions.
With the aim of improving the practices, the investigators took a closer look at the French recommendations. The Société de Réanimation de Langue Française (French Intensive Care Society) does not recommend a particular fixation method, but it does relay publications that shows the superiority of the AnchorfastTM device over adhesive tape fixation in terms of the incidence of pressure sores and accidental catheter mobilization.
The aim of this study is to assess the benefits of using the Anchorfast device in reducing complications associated with intubation tube fixation, in terms of the rate of pressure ulcer development, the rate of intubation tube mobilization and the rate of VAP occurrence. If the hypothesis is confirmed, this project would enable the caregivers to optimize the current practice in the interests of both patients and caregivers. That's why the investigators have designed a real-life study, and will also be looking at the effect of care load on and caregiver satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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 over 18 years old,
- •Patient with orotracheal intubation,
- •Patient intubated no more than 24 hours previously,
- •Oral consent from patient, trusted support person or relative if unable to consent
- •Membership of a French health insurance scheme.
排除标准
- •Pre-existing facial, labial or auricular skin lesions,
- •Pre-existing mucositis,
- •Patients extubated for more than 24 hours whose condition requires a new intubation tube
- •Nasotracheal intubation,
- •Planned early tracheotomy,
- •Patient with occipital craniectomy,
- •Patient in ventral position,
- •Pregnant or breast-feeding woman,
- •Patient deprived of liberty or under guardianship.
研究组 & 干预措施
Cord attachement
Caregivers follow the Tensoplast® white cord and elastic plaster fixation protocol, which has been revised and validated by the care department.
Tube care is carried out in two stages: preparing the patient for the procedure (safety and hygiene) then renewal of the fixation device.
干预措施: Corded tube care (Procedure)
AnchorFast
The AnchorFastTM fixation device developed by Laboratoire Hollister is a single-use medical device. This fixation system consists of a hard plastic guide on which the intubation tube can slide laterally.
It facilitate access to the oral cavity and limit pressure points on the corners of the mouth.
干预措施: Tube care attached by AnchorFast (Device)
Caregivers
The caregivers will be included as a study population. Caregivers will conduct the search for the other two arms (ancofast and by cord) and then fill in questionnaires assessing the workload and comfort of tube care.
干预措施: Caregiver's evaluation on each tube fixation (Other)
结局指标
主要结局
Comparison of induced pressure sores
时间窗: 16 months
Evaluate the change in the incidence rate of eschars (grade 1 or higher according to the National Pressure Ulcer Advisory Panel 1998 classification) induced by fixation of the intubation tube with the AnchorFastTM device compared with the cord fixation cord fixation technique.
次要结局
- Budgetary impact : comparison of the average total price per patient (consumables, labor), taking into account additional expenses in the event of medical complications related to the fixation system(16 months)
- Patient safety regarding the stability of the intubation : number of repositionning(16 months)
- Patient safety regarding the risk of accidental extubation(16 months)
- Impact on nursing staff care load(16 months)
- Impact on nursing staff comfort according to the Nursing Activity Score.(16 months)
- Patient safety regarding ventilator-associated pneumonia(16 months)
- Patient safety regarding intubation-related complications(16 months)