Long-term Outcomes of Post-intubation Tracheal Stenosis; 7-year Follow-up

Sponsor
Ankara Ataturk Sanatorium Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06121024
Collaborator
Yenimahalle Education and Research Hospital (Other)
75
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Study Details

Study Description

Brief Summary

This retrospective, observational, cohort study evaluates the treatment management, long-term outcomes and survival analyses in patients hospitalized in the Intensive Care Unit with a diagnosis of Post-Intubation Tracheal Stenosis (PITS) between 1st June 2016 and 1st June 2022. The study emphasizes the role of bronchoscopic interventions in treatment management and the effective and efficient use of health services.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Interventional Bronchoscopy

Detailed Description

This retrospective study will analyze data from adult patients aged 18 years and above who were admitted with a diagnosis of Post-Intubation Tracheal Stenosis to the intensive care units of Health Sciences University Ankara Atatürk Sanatorium Training and Research Hospital and Yenimahalle Training and Research Hospital between 2016 and 2022. The analysis will examine data from both the hospital registration system and the patients' intensive care files. Patients who have a history of malignancy contributing to tracheal stenosis, patients who have a history of congenital tracheal anomalies or tracheal stenosis, those with incomplete intensive care follow-up information, patient follow-up files or hospital information system data, and patients who have been repeatedly hospitalized (with only the first hospitalisation data taken into account) shall be eliminated from the study. If patients who were discharged from the intensive care unit have one-year post-discharge data, we will obtain the information from the hospital's follow-up system. If not, we will gather the information by calling them or their first-degree relatives by telephone. The post-discharge data is from a past period, and the one-year follow-up period for the last patient included in the study ends on 1st June 2023.

Our study aims to determine whether early diagnosis and interventional bronchoscopic treatment have an impact on the length of intensive care unit stay and prognosis for patients with Post-Intubation Tracheal Stenosis whilst in the intensive care unit. This will be achieved through an investigation of patient outcomes following appropriate interventions.

Study Design

Study Type:
Observational
Anticipated Enrollment :
75 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Long-term Outcomes of Intensive Care Unit Patients With Post-intubation Tracheal Stenosis; 7-year Follow-up
Actual Study Start Date :
Oct 12, 2023
Anticipated Primary Completion Date :
Nov 12, 2023
Anticipated Study Completion Date :
Nov 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Simple Tracheal Stenosis

Simple stenosis was defined as lesions with a vertical extension <1 cm (short segment) with endoluminal occlusion, without tracheomalacia or loss of cartilage support.

Procedure: Interventional Bronchoscopy
Bronchoscopy offers vital information when evaluating patients suffering from tracheal stenosis. It enables direct visualisation which identifies the lesion, determines its location and extent of airway involvement, highlights vascularity and fragility, allows for tissue diagnosis and enables the operator to assess the extent of mucosal infiltration and airway compression caused by the tumour. The technique facilitates assessment of stenosis diameter for suitable stent selection. In addition to enabling diagnostic bronchoscopy, rigid bronchoscopy offers therapeutic options such as dilatation, cryotherapy and stenting for tracheal stenosis patients. Our clinical setting employs rigid bronchoscopy for interventional procedures with both diagnostic and therapeutic aspects.
Other Names:
  • Rigid Bronchoscopy
  • Complex Tracheal Stenosis

    Complex stenosis were defined as lesions ≥1 cm and varying degrees of cartilage involvement or circumferential contractile scar or tracheal stenosis associated with malacia and inflammation.

    Procedure: Interventional Bronchoscopy
    Bronchoscopy offers vital information when evaluating patients suffering from tracheal stenosis. It enables direct visualisation which identifies the lesion, determines its location and extent of airway involvement, highlights vascularity and fragility, allows for tissue diagnosis and enables the operator to assess the extent of mucosal infiltration and airway compression caused by the tumour. The technique facilitates assessment of stenosis diameter for suitable stent selection. In addition to enabling diagnostic bronchoscopy, rigid bronchoscopy offers therapeutic options such as dilatation, cryotherapy and stenting for tracheal stenosis patients. Our clinical setting employs rigid bronchoscopy for interventional procedures with both diagnostic and therapeutic aspects.
    Other Names:
  • Rigid Bronchoscopy
  • Outcome Measures

    Primary Outcome Measures

    1. Mortality [1 year]

      One-year mortality data following interventional bronchoscopic treatment for post-intubation tracheal stenosis in patients hospitalized in the intensive care unit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age > 18,

    • Intensive care patients diagnosed with post-intubation tracheal stenosis (PITS)

    Exclusion Criteria:
    • Patients with a history of malignancy in the etiology of tracheal stenosis

    • Patients with a history of congenital tracheal anomaly or tracheal stenosis

    • Patients with missing intensive care follow-up form, patient follow-up file or hospital information system data

    • Repeated hospitalizations

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ankara Atatürk Sanatorium Training and Research Hospital Ankara Keçiören Turkey 06290

    Sponsors and Collaborators

    • Ankara Ataturk Sanatorium Training and Research Hospital
    • Yenimahalle Education and Research Hospital

    Investigators

    • Principal Investigator: Onur KÜÇÜK, specialist, Ankara Ataturk Sanatorium Training and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Onur Kucuk, Department of anesthesiology and reanimation, Principal Investigator, Specialist Doctor, Ankara Ataturk Sanatorium Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT06121024
    Other Study ID Numbers:
    • E-2023-52
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 7, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Onur Kucuk, Department of anesthesiology and reanimation, Principal Investigator, Specialist Doctor, Ankara Ataturk Sanatorium Training and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 7, 2023