Treatment for tracheal narrowing after tracheostomy
Interventional Therapy of Tracheal Stenosis After Percutaneous Tracheotomia
This study is testing if different treatments can help people with tracheal narrowing after a tracheostomy breathe better and eventually stop using their tracheal tube.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Asklepios Neurological Clinic Bad Salzhausen Academic / other |
| Locations | 1 site (Nidda) |
| Trial ID | NCT05924087 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with tracheal stenosis following tracheostomy, aiming to assess the effectiveness of therapies to alleviate symptoms and facilitate decannulation. After respiratory weaning, patients undergo tracheoscopy to confirm the presence of stenosis, and if symptomatic stenosis is identified, appropriate therapies such as cryotherapy are planned. The ultimate goal is to enable patients to breathe without a tracheal cannula, improving their quality of life. The study is observational and does not specify particular interventions beyond the assessment of stenosis and subsequent therapy.
Who should consider this trial
Good fit: Ideal candidates are individuals with tracheal stenosis resulting from percutaneous tracheotomy.
Not a fit: Patients who have undergone surgical tracheotomy or have laryngeal involvement will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the ability of patients to breathe independently without the need for a tracheal cannula.
How similar studies have performed: While this approach is not definitively established as a standard therapy, similar studies have explored interventions for tracheal stenosis with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Tracheal stenosis after percutaneous tracheotomy. Exclusion Criteria: * Pregnant or breast-feeding women of childbearing potential who refuse pregnancy test. * lack of consent to participate in the study. * surgical tracheotomy. * Involvement of the larynx (above the first tracheal brace).
Where this trial is running
Nidda
- Neurologische Klinik Bad Salzhausen — Nidda, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.