Prolonged WeaningDYSTRACHNCT06185998
Impact of the Nature and Interface of the Tracheostomy Cannula on Dyspnea in Patients Weaning From Artificial Ventilation in Weaning Unit
A study testing low pressure tracheostomy cannulas and plated balloon tracheostomy cannulas in people with Prolonged Weaning, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolonged Weaning
- What is being tested?
- low pressure tracheostomy cannulas and plated balloon tracheostomy cannulas
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Prolonged Weaning
- Being tested
- low pressure tracheostomy cannulas, plated balloon tracheostomy cannulas
- Keywords
- prolonged weaning, tracheostomy, dyspnea
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low pressure tracheostomy cannulasDevice
Also called 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
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
plated balloon tracheostomy cannulasDevice
Also called Bivona® TTS™ Tracheostomy Tubes, silicone tube TTS™ cuff, tubes are coated with a SuperSlick®, soft, confort and flexible tube
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
| Study group | Role | What they receive |
|---|---|---|
| plated balloon tracheostomy cannulas | Experimental | 4 interfaces are tested: cap, ventilator, filter and phonation valve Receives: Device: low pressure tracheostomy cannulas; Device: plated balloon tracheostomy cannulas |
| low pressure balloon tracheotomy cannulas | Active comparator | 4 interfaces are tested: cap, ventilator, filter and phonation valve Receives: Device: low pressure tracheostomy cannulas; Device: plated balloon tracheostomy cannulas |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes after using each interfaces
Secondary outcomes (10)
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.
Measured: 30 minutes after using each interfaces
Multidimensional Dyspnea Profile (MDP)
The Multidimensional Dyspnea Profile (MDP) assesses overall breathing discomfort, sensory qualities, and emotional responses
Measured: 30 minutes after using each interfaces
Biological variable : Heart rate
Heart rate (beat per minute)
Measured: 30 minutes after using each interfaces
Biological variable : Respiratory rate
Respiratory rate (cycles per minute)
Measured: 30 minutes after using each interfaces
Biological variable : Systolic and diastolic systemic blood pressure
Systolic and diastolic systemic blood pressure (millimeters of mercury - mmHg)
Measured: 30 minutes after using each interfaces
Biological variable : Pulsed oxygen saturation
Pulsed oxygen saturation (percentage %)
Measured: 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
Measured: 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
Measured: 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
Measured: 30 minutes after using each interfaces
use of anxiolytic drugs
the type of molecule, dosage and route of administration will be identified
Measured: 30 minutes after using each interfaces
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study startSep 2024 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged WeaningStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Delemazure, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185998
- Sponsor's protocol ID
- APHP230863
- Acronym
- DYSTRACH
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2023
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Nature and Interface of the Tracheostomy Cannula on Dyspnea in Patients Weaning From Artificial Ventilation in Weaning Unit
- ClinicalTrials.gov ID
- NCT06185998
- Acronym / sponsor ID
- DYSTRACH / APHP230863
- Conditions
- Prolonged Weaning
- Keywords
- prolonged weaning, tracheostomy, dyspnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plated balloon tracheostomy cannulas | Experimental | Device: low pressure tracheostomy cannulas, Device: plated balloon tracheostomy cannulas4 interfaces are tested: cap, ventilator, filter and phonation valve |
| low pressure balloon tracheotomy cannulas | Active comparator | Device: low pressure tracheostomy cannulas, Device: plated balloon tracheostomy cannulas4 interfaces are tested: cap, ventilator, filter and phonation valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low pressure tracheostomy cannulasAlso: 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 cannulaThe 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 | Device | low pressure balloon tracheotomy cannulas, plated balloon tracheostomy cannulas |
| plated balloon tracheostomy cannulasAlso: Bivona® TTS™ Tracheostomy Tubes, silicone tube TTS™ cuff, tubes are coated with a SuperSlick®, soft, confort and flexible tubeThe 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 | Device | low pressure balloon tracheotomy cannulas, plated balloon tracheostomy cannulas |
Primary outcome
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.
10 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Delemazure principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing low pressure tracheostomy cannulas and plated balloon tracheostomy cannulas in people with Prolonged Weaning, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Delemazure (+33 1 84 82 75 72, julie.delemazure@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea visual analogic scale (VAS) with cap (time frame: 30 minutes after using each interfaces). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.