An interventional study of low pressure tracheostomy cannulas and plated balloon tracheostomy cannulas in Prolonged Weaning, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-19.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Supportive care
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.
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:
It is a cross-over including 76 patients, with each serving as their his own control, over 25 months.
681 studies on the registry are indexed under Dyspnea; 159 are open to participants now.
This study's planned enrollment of 76 is above the median of 48 across 447 interventional studies indexed under Dyspnea.
Browse Dyspnea studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
4 interfaces are tested: cap, ventilator, filter and phonation valve
Device: low pressure tracheostomy cannulas · Device: plated balloon tracheostomy cannulas
4 interfaces are tested: cap, ventilator, filter and phonation valve
Device: low pressure tracheostomy cannulas · 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 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
Also known as: 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
Also known as: Bivona® TTS™ Tracheostomy Tubes, silicone tube TTS™ cuff, tubes are coated with a SuperSlick®, soft, confort and flexible tube
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.
Time frame: 30 minutes after using each interfaces
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.
Time frame: 30 minutes after using each interfaces
Multidimensional Dyspnea Profile (MDP)
The Multidimensional Dyspnea Profile (MDP) assesses overall breathing discomfort, sensory qualities, and emotional responses
Time frame: 30 minutes after using each interfaces
Biological variable : Heart rate
Heart rate (beat per minute)
Time frame: 30 minutes after using each interfaces
Biological variable : Respiratory rate
Respiratory rate (cycles per minute)
Time frame: 30 minutes after using each interfaces
Biological variable : Systolic and diastolic systemic blood pressure
Systolic and diastolic systemic blood pressure (millimeters of mercury - mmHg)
Time frame: 30 minutes after using each interfaces
Biological variable : Pulsed oxygen saturation
Pulsed oxygen saturation (percentage %)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 30 minutes after using each interfaces
use of anxiolytic drugs
the type of molecule, dosage and route of administration will be identified
Time frame: 30 minutes after using each interfaces
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Access criteria: Researchers who provide a methodologically sound proposal.
No publications or documents are linked to this record.
Start is estimated for Sep 2024; primary completion for Oct 2026, 25 months later.
Of 212 non-industry interventional studies with no phase under Dyspnea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's planned 25 months is above that.
Counting every sponsor, half of 226 studies reached it within 14 months; a quarter within 6 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique - Hôpitaux de Paris →