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

NCT ID: NCT06121024

Last Updated: 2023-12-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-12
• Study Completion Date: 2023-11-15

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.

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, the investigators will obtain the information from the hospital's follow-up system. Otherwise, investigators will collect information by calling patients or patients first-degree relatives by phone.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.

The aim of the study is 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.

Conditions

Tracheal Stenosis; Intensive Care Unit

Keywords

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Interventional Bronchoscopy

Intervention Type: 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.

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.

Interventional Bronchoscopy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Rigid Bronchoscopy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yenimahalle Education and Research Hospital

OTHER

Sponsor Role: collaborator

Ankara Ataturk Sanatorium Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Onur Kucuk

Department of anesthesiology and reanimation, Principal Investigator, Specialist Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Onur KÜÇÜK, specialist

Role: PRINCIPAL_INVESTIGATOR

Ankara Ataturk Sanatorium Training and Research Hospital

Locations

Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Keçiören, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-2023-52

Identifier Type: -

Identifier Source: org_study_id