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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of the Nature and Interface of the Tracheostomy Cannula on Dyspnea in Patients Weaning From Artificial Ventilation in Weaning Unit

Conditions
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Prolonged Weaning

Intervention / Treatment
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* Device: low pressure tracheostomy cannulas
* Device: plated balloon tracheostomy cannulas


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: plated balloon tracheostomy cannulas<br>4 interfaces are tested: cap, ventilator, filter and phonation valve | Device: low pressure tracheostomy cannulas<br>* The tracheostomy tube is changed according to the randomization sequence, a filter is connected for 5 minutes; then baseline data will be assessed. The tracheostomy tube is then connected to the four interfaces for 30 minutes each. Parameters is measured after each 30-minute period. The cuff of the tracheostomy tube will be deflated using a syringe when the interface is a filter, phonation valve, or cap. In contrast, the cuff will be inflated when the interface is the ventilator. The cuff is inflated with a manometer for the low-pressure balloon tracheostomy tube and with the minimum and sufficient amount of injectable water for the plated balloon tracheostomy tube to avoid overpressure<br>* Other names: low wall thickness and a good fit of the inner cannula in the outer cannula;Device: plated balloon tracheostomy cannulas<br>* The tracheostomy tube is changed according to the randomization sequence, a filter is connected for 5 minutes; then baseline data will be assessed. The tracheostomy tube is then connected to the four interfaces for 30 minutes each. Parameters is measured after each 30-minute period. The cuff of the tracheostomy tube will be deflated using a syringe when the interface is a filter, phonation valve, or cap. In contrast, the cuff will be inflated when the interface is the ventilator. The cuff is inflated with a manometer for the low-pressure balloon tracheostomy tube and with the minimum and sufficient amount of injectable water for the plated balloon tracheostomy tube to avoid overpressure<br>* Other names: soft, confort and flexible tube;|
| Active Comparator: low pressure balloon tracheotomy cannulas<br>4 interfaces are tested: cap, ventilator, filter and phonation valve | Device: low pressure tracheostomy cannulas<br>* The tracheostomy tube is changed according to the randomization sequence, a filter is connected for 5 minutes; then baseline data will be assessed. The tracheostomy tube is then connected to the four interfaces for 30 minutes each. Parameters is measured after each 30-minute period. The cuff of the tracheostomy tube will be deflated using a syringe when the interface is a filter, phonation valve, or cap. In contrast, the cuff will be inflated when the interface is the ventilator. The cuff is inflated with a manometer for the low-pressure balloon tracheostomy tube and with the minimum and sufficient amount of injectable water for the plated balloon tracheostomy tube to avoid overpressure<br>* Other names: low wall thickness and a good fit of the inner cannula in the outer cannula;Device: plated balloon tracheostomy cannulas<br>* The tracheostomy tube is changed according to the randomization sequence, a filter is connected for 5 minutes; then baseline data will be assessed. The tracheostomy tube is then connected to the four interfaces for 30 minutes each. Parameters is measured after each 30-minute period. The cuff of the tracheostomy tube will be deflated using a syringe when the interface is a filter, phonation valve, or cap. In contrast, the cuff will be inflated when the interface is the ventilator. The cuff is inflated with a manometer for the low-pressure balloon tracheostomy tube and with the minimum and sufficient amount of injectable water for the plated balloon tracheostomy tube to avoid overpressure<br>* Other names: soft, confort and flexible tube;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea visual analogic scale (VAS) with cap | 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. | 30 minutes after using each interfaces | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea visual analogic scale (VAS) after 30 min breathing with filter, ventilator and phonation valve | 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. | 30 minutes after using each interfaces | 
| Multidimensional Dyspnea Profile (MDP) | The Multidimensional Dyspnea Profile (MDP) assesses overall breathing discomfort, sensory qualities, and emotional responses | 30 minutes after using each interfaces | 
| Biological variable : Heart rate | Heart rate (beat per minute) | 30 minutes after using each interfaces | 
| Biological variable : Respiratory rate | Respiratory rate (cycles per minute) | 30 minutes after using each interfaces | 
| Biological variable : Systolic and diastolic systemic blood pressure | Systolic and diastolic systemic blood pressure (millimeters of mercury - mmHg) | 30 minutes after using each interfaces | 
| Biological variable : Pulsed oxygen saturation | Pulsed oxygen saturation (percentage %) | 30 minutes after using each interfaces | 
| Pain visual analogic scales (VAS) | evaluate the severity of pain the index has 10 numerical values, rated on a scale from 0-10, each value corresponding to an intensity pain and anxiety. It is an easy-to-use scale for patients | 30 minutes after using each interfaces | 
| Anxiety visual analogic scales (VAS) | evaluate the severity of anxiety the index has 10 numerical values, rated on a scale from 0-10, each value corresponding to an intensity pain and anxiety. It is an easy-to-use scale for patients | 30 minutes after using each interfaces | 
| use of analgesic anti dyspnoetics drugs (morphine and derivatives) | the type of molecule, dosage and route of administration will be identified | 30 minutes after using each interfaces | 
| use of anxiolytic drugs | the type of molecule, dosage and route of administration will be identified | 30 minutes after using each interfaces | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prolonged weaning, tracheostomy, dyspnea