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

NCT06121024 | Completed

• 1 other identifier: E-2023-52
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheal Stenosis; Intensive Care Unit

Keywords

tracheal stenosis; post-intubation tracheal stenosis; intensive care unit; interventional bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Mortality

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

  1 year

Study Arms (2)

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

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

Interventions

Interventional Bronchoscopy PROCEDURE

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.

Also known as: Rigid Bronchoscopy

Complex Tracheal Stenosis; Simple Tracheal Stenosis

Eligibility Criteria

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

Study Population

This retrospective study will analyze data from adult patients aged 18 years and above who were admitted with a diagnosis of PITS 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. 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.

You may qualify if:

• Age \> 18,
• Intensive care patients diagnosed with post-intubation tracheal stenosis (PITS)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Ataturk Sanatorium Training and Research Hospital: lead
• Yenimahalle Education and Research Hospital: collaborator

Study Sites (1)

Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Keçiören, 06290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tracheal Stenosis

Condition Hierarchy (Ancestors)

Tracheal Diseases; Respiratory Tract Diseases

Study Officials

• Onur KÜÇÜK, specialist

  Ankara Ataturk Sanatorium Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of anesthesiology and reanimation, Principal Investigator, Specialist Doctor

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 7, 2023
• Study Start: October 12, 2023
• Primary Completion: November 12, 2023
• Study Completion: November 15, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)