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NCT Number: NCT05924087

Interventional Therapy of Tracheal Stenosis

After respiratory weaning, decannulation is sought. To do this, the tracheal cannula is first unblocked, so that patients no longer breathe in and out through the cannula, but (at least partially) "passing" the cannula by the natural route. In the presence of tracheal stenosis there is increased breathing effort, possibly restlessness and stridor. This constellation of symptoms suggests the suspicion of tracheal stenosis, so in the next step a tracheoscopy is performed to confirm or exclude tracheal stenosis. In case of symptomatic tracheal stenosis and at least 30-50% stenosis of the trachea (clinical symptoms can be expected from a 30-50% stenosis) then appropriate therapy (here: cryotherapy, other techniques only in exceptional cases) is planned. The goal is to be able to remove the tracheal cannula (long term) after successful therapy, so that patients do not have to be permanently provided with a tracheal cannula. There is no definitive/evidence-based standard therapy for the treatment of tracheal stenosis. Cryotherapy is a gentle therapy that has already been applied and described for the treatment of tracheal stenosis (see above). The examination is performed as part of an analgesic dose, as is routine for a bronchoscopy (in-house SOP). After treatment, a follow-up is planned for about 10 days later.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Decannulation

    Time frame: 12 months

    Rate of successful decannulations after intervention up to discharge from inpatient treatment.

Secondary outcomes

  1. Technical success

    Time frame: 12 months

    technical success of the intervention (endoscopically not clinically relevant tracheal stenosis).

  2. Reintervention(s)

    Time frame: 12 months

    Number of interventions required.

  3. Type of intervention

    Time frame: 12 months

    Type of intervention(s) (cyroablation, APC, loop extraction).

  4. Clinical success

    Time frame: 12 months

    Clinical success (no stridor, no dyspnoea).

  5. Additional treatment

    Time frame: 12 months

    Number of patients requiring surgical treatment/stent.

Sponsors and collaborators

Lead sponsor

Asklepios Neurological Clinic Bad Salzhausen

Other

Registry information

Official study title

Interventional Therapy of Tracheal Stenosis After Percutaneous Tracheotomia

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 29, 2023
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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