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

Long-term Outcomes of Intensive Care Unit Patients With 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.

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit; Tracheal Stenosis
• Intervention / Treatment: 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, 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.

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• Turkey
  • Keçiören
    • Ankara, Keçiören, Turkey, 06290
      • ANKARA ATATURK SANATORİUM TRAİNİNG AND RESEARCH HOSPITAL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	One-year mortality data following interventional bronchoscopic treatment for post-intubation tracheal stenosis in patients hospitalized in the intensive care unit	1 year

Collaborators and Investigators

• Sponsor: Ankara Ataturk Sanatorium Training and Research Hospital
• Collaborators: Yenimahalle Education and Research Hospital
• Investigators: Principal Investigator: Onur KÜÇÜK, specialist, ANKARA ATATURK SANATORİUM TRAİNİNG AND RESEARCH HOSPITAL

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Actual): November 12, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: intensive care unit; tracheal stenosis; interventional bronchoscopy; post-intubation tracheal stenosis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pathological Conditions, Anatomical; Tracheal Diseases; Constriction, Pathologic; Tracheal Stenosis
• Other Study ID Numbers: E-2023-52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No