NCT06930222

Brief Summary

This prospective study aimed to predict morbidity and mortality after thoracic trauma in intensive care unit evaluated clinical and biochemical data of 50 intensive care unit patients. The research examined demographic factors such as gender, age, and smoking status, trauma scoring systems like ISS and RTS as well as biomarkers such as Surfactant-d and oxygenation parameters including the ROX index, PaO₂/FiO₂ ratio and FiO₂.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 16, 2025

Completed
Last Updated

April 16, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

January 3, 2025

Last Update Submit

April 8, 2025

Conditions

Keywords

thorax traumaROX indexSurfactant-d

Outcome Measures

Primary Outcomes (2)

  • Mortality Prediction Using ROX Index in Thoracic Trauma Patients

    To evaluate the predictive ability of the ROX index (unit: cmH₂O/L/s) for mortality in thoracic trauma patients. ROX index values were recorded at 1st, 3rd, and 7th days of hospitalization using standard clinical monitoring and ventilatory support parameters. Trends were analyzed in relation to survival outcomes.

    Measurements taken on day 1, day 3, and day 7 of hospitalization, following ICU admission.

  • Mortality Prediction Using SP-D Levels in Thoracic Trauma Patients

    To assess the prognostic value of Surfactant Protein D (SP-D) levels (unit: ng/mL) for mortality prediction in thoracic trauma patients. SP-D levels were measured using an ELISA assay (Elabscience® Human Pulmonary Surfactant-associated Protein-D ELISA Kit) at 1st, 3rd, and 7th days to evaluate trends and correlations with survival outcomes.

    Measurements taken on day 1, day 3, and day 7 of hospitalization, following ICU admission.

Secondary Outcomes (6)

  • Predictive Value of APACHE II Score in Mortality

    Measurements taken on day 1, day 3, and day 7 of hospitalization.

  • Predictive Value of SOFA Score in Mortality

    Measurements taken on day 1, day 3, and day 7 of hospitalization.

  • Predictive Value of TRISS Score in Mortality

    Measurements taken on day 1, day 3, and day 7 of hospitalization.

  • Predictive Value of RTS Score in Mortality

    Measurements taken on day 1, day 3, and day 7 of hospitalization.

  • CRP Levels and Mortality Prediction

    Measurements taken on day 1, day 3, and day 7 of hospitalization.

  • +1 more secondary outcomes

Other Outcomes (2)

  • NEU/LYM Ratio and Mortality Correlation

    Measurements taken on day 1, day 3, and day 7 of hospitalization.

  • Glasgow Coma Scale (GCS) and Mortality Correlation

    Measurements taken on day 1, day 3, and day 7 of hospitalization.

Study Arms (1)

thorax trauma patients

thorax trauma patients admitted to icu

Diagnostic Test: blood sampling

Interventions

blood samplingDIAGNOSTIC_TEST

blood samples obtained for 3 different days, limited to 5cc

thorax trauma patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with thoracic trauma admitted to icu

You may qualify if:

  • Patients with thoracic trauma between the ages of 18-85
  • Patients who have been monitored in intensive care for at least 1 week

You may not qualify if:

  • Being outside the age range of 18-85
  • Pregnant patients
  • Patients whose intensive care follow-up lasted less than 1 week
  • Patients who do not want to be included in the study
  • Patients with a lung malignancy diagnosis before admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suleyman Demirel University

Isparta, 32260, Turkey (Türkiye)

Location

Related Publications (3)

  • Determann RM, Royakkers AA, Haitsma JJ, Zhang H, Slutsky AS, Ranieri VM, Schultz MJ. Plasma levels of surfactant protein D and KL-6 for evaluation of lung injury in critically ill mechanically ventilated patients. BMC Pulm Med. 2010 Feb 16;10:6. doi: 10.1186/1471-2466-10-6.

    PMID: 20158912BACKGROUND
  • Baker JE, Millar DA, Heh V, Goodman MD, Pritts TA, Janowak CF. Does chest wall Organ Injury Scale (OIS) or Abbreviated Injury Scale (AIS) predict outcomes? An analysis of 16,000 consecutive rib fractures. Surgery. 2020 Jul;168(1):198-204. doi: 10.1016/j.surg.2020.04.032. Epub 2020 May 13.

    PMID: 32507628BACKGROUND
  • Lundin A, Akram SK, Berg L, Goransson KE, Enocson A. Thoracic injuries in trauma patients: epidemiology and its influence on mortality. Scand J Trauma Resusc Emerg Med. 2022 Dec 12;30(1):69. doi: 10.1186/s13049-022-01058-6.

    PMID: 36503613BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hemogram Biochemical markers arterial blood gas analyses

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • pınar karabacak

    Suleyman Demirel University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RESEARCH ASSISTANT

Study Record Dates

First Submitted

January 3, 2025

First Posted

April 16, 2025

Study Start

April 15, 2023

Primary Completion

March 15, 2024

Study Completion

April 15, 2024

Last Updated

April 16, 2025

Record last verified: 2025-03

Locations