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

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.

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Key information

Conditions

Tracheal Stenosis Intensive Care Unit Respiratory Tract Diseases Tracheal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Keçiören, 06290, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Other names: Rigid Bronchoscopy

Primary outcomes

Mortality

Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Ankara Ataturk Sanatorium Training and Research Hospital

Other Gov

Collaborators

Yenimahalle Education and Research Hospital

Registry information

Official study title

Long-term Outcomes of Intensive Care Unit Patients With Post-intubation Tracheal Stenosis; 7-year Follow-up

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Nov 7, 2023
Registry last updated: Dec 1, 2023

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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Completed