Impact of the Nature and Interface of the Tracheostomy Cannula on Dyspnea in Patients Weaning From Artificial Ventilation in Weaning Unit (DYSTRACH)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Prolonged Weaning

Treatments: Device: plated balloon tracheostomy cannulas; Device: low pressure tracheostomy cannulas

Study type: Interventional

Funder types: Other

Identifiers

NCT06185998

APHP230863

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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76 participants in 2 patient groups

plated balloon tracheostomy cannulas

Experimental group

Description:

4 interfaces are tested: cap, ventilator, filter and phonation valve

Treatment:

Device: low pressure tracheostomy cannulas

Device: plated balloon tracheostomy cannulas

low pressure balloon tracheotomy cannulas

Active Comparator group

Description:

4 interfaces are tested: cap, ventilator, filter and phonation valve

Treatment:

Device: low pressure tracheostomy cannulas

Device: plated balloon tracheostomy cannulas