Status:
NOT_YET_RECRUITING
Impact of the Nature and Interface of the Tracheostomy Cannula on Dyspnea in Patients Weaning From Artificial Ventilation in Weaning Unit
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Prolonged Weaning
Eligibility:
All Genders
18+ years
Phase:
NA
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-D...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06185998
Start Date
September 1 2024
End Date
October 1 2026
Last Update
July 19 2024
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