About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- low pressure tracheostomy cannulas
- plated balloon tracheostomy cannulas