Impact of the Nature and Interface of the Tracheostomy Cannula on Dyspnea in Patients Weaning From Artificial Ventilation in Weaning Unit
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 主要终点
- Dyspnea visual analogic scale (VAS) with cap
研究概览
简要总结
This trial aims to assess dyspnea intensity in tracheostomized patients undergoing prolonged artificial ventilation weaning. The primary outcome is dyspnea measured by the Visual Analogue Scale (VAS-Dyspnea). A comparison between low-pressure balloon tracheostomy cannula and plated balloon cannula and four interfaces (Cap, ventilator, phonation valve, or filter) are tested. The secondary outcomes including Multidimensional Dyspnea Profile, pain, anxiety VAS, and tolerance under different interfaces. The multicenter, cross-over study involves 76 patients over 25 months, each serving as their own control. Cap is always evaluated first but the order of the three interfaces (ventilator, phonation valve, or filter) and type of cannula are chosen by randomization. The study is conducted in three weaning centers (SRPR units) at Pitié-Salpêtrière, Bligny, and Forcilles.
详细描述
Dyspnea is common in patients ventilated in intensive care and SRPR units, and it can generate states of post-traumatic stress. Due to the prolonged duration of artificial ventilation, tracheostomized patients, for the purpose of prolonged weaning from artificial ventilation, are particularly exposed to dyspnea.
The main objective is to compare the respective impact of a low-pressure balloon tracheostomy cannula and a plated balloon cannula on the dyspnea intensity of tracheostomized patients in spontaneous ventilation, with the cannula closed by a cap. The primary outcome is the Visual Analogue Scale (VAS) for dyspnea (VAS-Dyspnea).
The investigators will compare low pressure versus plated balloon tracheostomy cannulas, considering the sensory and emotional components of dyspnea, as well as tolerance, pain, comfort, and anxiety under four different interfaces: ventilator, phonation valve, Cap, or filter. This will be measured through the following secondary outcomes:
- VAS-Dyspnea
- Multidimensional Dyspnea Profile
- Pain and anxiety VAS This multicenter study (SRPR Pitié-Salpêtrière, Bligny, and Forcilles) will be randomized in a cross-over design, comparing the use of two types of low-pressure or plated balloon cannulas over two consecutive days. For each cannula, four interfaces will be connected in a row starting with the cap. The order in which the other three interfaces will be set up will be randomized (ventilator, filter, and phonation valve).
It is a cross-over including 76 patients, with each serving as their his own control, over 25 months.
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
- Single (Participant)
盲法说明
Single blind
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 aged 18 years or older
- •Patient admitted to SRPR with respiratory and hemodynamic stability
- •Patient with a tracheostomy tube
- •Deflated balloon for more than 6 hours per day
- •Able to tolerate at least 1 hour on cap and phonation valve (deflated balloon)
- •Able to remain at least 3 consecutive hours without ventilation
- •Patient with at least one non-zero dyspnea numerical rating scale (NRS) score in the 72 hours preceding inclusion
- •Able to respond to self-administered questionnaires on dyspnea
- •Patients affiliated with a social security system or beneficiaries of such a system (excluding State Medical Assistance)
- •Patients who have given their informed consent
- •No significant expected changes in the administration of anxiolytic and analgesic treatments with anti-dyspneic properties within 2 days
排除标准
- •Pregnant women (verified by a blood or urine test during hospitalization for all women of childbearing age)
- •Patients deprived of liberty or under legal protection (guardianship or curatorship)
- •Patients unable to consent to the research
- •Contraindication to the use of a 7 mm tracheostomy tube
- •Patient presenting the combination of major swallowing disorders and excessive salivary secretion making the deflation of the tracheostomy tube balloon
结局指标
主要结局
Dyspnea visual analogic scale (VAS) with cap
时间窗: 30 minutes after using each interfaces
The VAS of dyspnoea evaluate the severity of dyspnoea, the index has 10 numerical values, rated on a scale from 0-10, each value corresponding to an intensity of breathlessness. It is an easy-to-use scale for patients.
次要结局
- Biological variable : Pulsed oxygen saturation(30 minutes after using each interfaces)
- Biological variable : Respiratory rate(30 minutes after using each interfaces)
- Anxiety visual analogic scales (VAS)(30 minutes after using each interfaces)
- use of anxiolytic drugs(30 minutes after using each interfaces)
- Multidimensional Dyspnea Profile (MDP)(30 minutes after using each interfaces)
- Biological variable : Systolic and diastolic systemic blood pressure(30 minutes after using each interfaces)
- Pain visual analogic scales (VAS)(30 minutes after using each interfaces)
- Dyspnea visual analogic scale (VAS) after 30 min breathing with filter, ventilator and phonation valve(30 minutes after using each interfaces)
- Biological variable : Heart rate(30 minutes after using each interfaces)
- use of analgesic anti dyspnoetics drugs (morphine and derivatives)(30 minutes after using each interfaces)