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NCT Number: NCT06185998

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

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.

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Key information

Conditions

Prolonged Weaning Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low pressure tracheostomy cannulas

Device

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

Other names: non fenestrated TRACOE® twist, TRACOE tracheostomy tubes with low-pressure cuff, low wall thickness and a good fit of the inner cannula in the outer cannula

plated balloon tracheostomy cannulas

Device

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

Other names: Bivona® TTS™ Tracheostomy Tubes, silicone tube TTS™ cuff, tubes are coated with a SuperSlick®, soft, confort and flexible tube

Primary outcomes

  1. Dyspnea visual analogic scale (VAS) with cap

    Time frame: 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.

Secondary outcomes

  1. Dyspnea visual analogic scale (VAS) after 30 min breathing with filter, ventilator and phonation valve

    Time frame: 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.

  2. Multidimensional Dyspnea Profile (MDP)

    Time frame: 30 minutes after using each interfaces

    The Multidimensional Dyspnea Profile (MDP) assesses overall breathing discomfort, sensory qualities, and emotional responses

  3. Biological variable : Heart rate

    Time frame: 30 minutes after using each interfaces

    Heart rate (beat per minute)

  4. Biological variable : Respiratory rate

    Time frame: 30 minutes after using each interfaces

    Respiratory rate (cycles per minute)

  5. Biological variable : Systolic and diastolic systemic blood pressure

    Time frame: 30 minutes after using each interfaces

    Systolic and diastolic systemic blood pressure (millimeters of mercury - mmHg)

  6. Biological variable : Pulsed oxygen saturation

    Time frame: 30 minutes after using each interfaces

    Pulsed oxygen saturation (percentage %)

  7. Pain visual analogic scales (VAS)

    Time frame: 30 minutes after using each interfaces

    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

  8. Anxiety visual analogic scales (VAS)

    Time frame: 30 minutes after using each interfaces

    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

  9. use of analgesic anti dyspnoetics drugs (morphine and derivatives)

    Time frame: 30 minutes after using each interfaces

    the type of molecule, dosage and route of administration will be identified

  10. use of anxiolytic drugs

    Time frame: 30 minutes after using each interfaces

    the type of molecule, dosage and route of administration will be identified

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Delemazure

CONTACT

[email protected]

+33 1 84 82 75 72

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: DYSTRACH

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2023
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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