Impact of continuous 'above cuff ventilation' on aspiration status in neurogenic dysphagia - VENTURA

Helios Klinikum Krefeld GmbH0 个研究点目标入组 56 人开始时间: 2024年6月21日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Patients with dysphagia and an inserted tracheostomy tube,
•-Tracheostoma (surgical or dilative) with partially unblocked tracheostomy tube (min. 6 hours per day),
•-Tracheal cannula with subglottic suction (Trachoe vario extract). The cannula must be approved for subglottic insufflation of compressed air (Trachoe vario extract: REF: 470, REF: 471 with CE approval),
•- Feasibility of the FEES
•-Written declaration of consent from the patient or their legal representative
•-There are no contraindications for the use of Trachoe tracheostomy tubes with subglottic suction line

•-Participation in other interventional examinations,
•-tracheomalacia,
•-Patients with fresh tracheostomy (less than 7 days after stoma creation)
•-ENT tumor surgery or radiation in the throat area,
•-Pre-existing oesophageal dysphagia (achalasia, motility disorder),
•-Continuous ventilation,
•-Obstruction of the upper airways
•-Patients with surgically induced emphysema or infections of the tracheal tissue
•-Pregnancy or breastfeeding,
•-Persons who are in a dependent / employment relationship with the sponsor, supporter or investigator
•-Placement in an institution due to a court or official order.
•-Deep sedation

发起方

Helios Klinikum Krefeld GmbH