Clinical trial NCT06121024: Long-term Outcomes of Post-intubation Tracheal Stenosis; 7-year Follow-up
Official title: Long-term Outcomes of Intensive Care Unit Patients With Post-intubation Tracheal Stenosis; 7-year Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheal Stenosis
Intensive Care Unit
Keywords: tracheal stenosis
post-intubation tracheal stenosis
intensive care unit
interventional bronchoscopy
Lead sponsor: Ankara Ataturk Sanatorium Training and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Yenimahalle Education and Research Hospital
First posted: 2023-11-07
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Atatürk Sanatorium Training and Research Hospital
state: Keçiören
Study officials:
affiliation: Ankara Ataturk Sanatorium Training and Research Hospital
name: Onur KÜÇÜK, specialist
role: PRINCIPAL_INVESTIGATOR
References: