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Not yet recruiting NCT06185998

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

No phase Interventional Prolonged Weaning

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: low pressure tracheostomy cannulas, plated balloon tracheostomy cannulas.
Who it may be relevant to
Registry conditions: Prolonged Weaning. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

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.

Interventions

  • Device low pressure tracheostomy cannulas
    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 in
  • Device plated balloon tracheostomy cannulas
    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 in

Primary outcome measures

  • Dyspnea visual analogic scale (VAS) with cap [Time frame: 30 minutes after using each interfaces]
Secondary outcome measures (10)
  • Dyspnea visual analogic scale (VAS) after 30 min breathing with filter, ventilator and phonation valve [Time frame: 30 minutes after using each interfaces]
  • Multidimensional Dyspnea Profile (MDP) [Time frame: 30 minutes after using each interfaces]
  • Biological variable : Heart rate [Time frame: 30 minutes after using each interfaces]
  • Biological variable : Respiratory rate [Time frame: 30 minutes after using each interfaces]
  • Biological variable : Systolic and diastolic systemic blood pressure [Time frame: 30 minutes after using each interfaces]
  • Biological variable : Pulsed oxygen saturation [Time frame: 30 minutes after using each interfaces]
  • Pain visual analogic scales (VAS) [Time frame: 30 minutes after using each interfaces]
  • Anxiety visual analogic scales (VAS) [Time frame: 30 minutes after using each interfaces]
  • use of analgesic anti dyspnoetics drugs (morphine and derivatives) [Time frame: 30 minutes after using each interfaces]
  • use of anxiolytic drugs [Time frame: 30 minutes after using each interfaces]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06185998 · APHP230863

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗