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

NCT06185998 | Not Yet Recruiting

• 1 other identifier: APHP230863
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Prolonged Weaning

Keywords

prolonged weaning; tracheostomy; dyspnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

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

  30 minutes after using each interfaces

• Multidimensional Dyspnea Profile (MDP)

  30 minutes after using each interfaces

• Biological variable : Heart rate

  30 minutes after using each interfaces

• Biological variable : Respiratory rate

  30 minutes after using each interfaces

• Biological variable : Systolic and diastolic systemic blood pressure

  30 minutes after using each interfaces

Study Arms (2)

plated balloon tracheostomy cannulas

EXPERIMENTAL

4 interfaces are tested: cap, ventilator, filter and phonation valve

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

Device: low pressure tracheostomy cannulas; Device: plated balloon tracheostomy cannulas

Interventions

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

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

low pressure balloon tracheotomy cannulas; plated balloon tracheostomy cannulas

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

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

low pressure balloon tracheotomy cannulas; plated balloon tracheostomy cannulas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Delemazure

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Delemazure

CONTACT

+33 1 84 82 75 72; julie.delemazure@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 29, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 19, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.