NCT06651931

Brief Summary

Acute respiratory failure is a primary cause of intensive care unit admissions. It occurs when the lungs fail to adequately oxygenate arterial blood and/or prevent carbon dioxide retention. While the definition does not include absolute values, arterial PaO2 below 60 mmHg and arterial PaCO2 above 50 mmHg are generally accepted as indicators. However, these values should be interpreted in the context of individual patient characteristics. Pneumonia remains the most common etiology of acute respiratory failure. Typically of infectious origin, pneumonia alters respiratory mechanics, disrupting the lung's gas exchange function, ventilation-perfusion balance, and volumetric spirometric parameters. Mortality and morbidity rates increase significantly when pneumonia patients require invasive mechanical ventilation. Recent advancements in quantitative CT technology enable clinicians to assess the volumetric state of the lungs without performing spirometric tests. Volumetric lung measurements aid in diagnosing lung diseases, assessing severity, planning treatment strategies, and predicting prognosis. Numerous studies have demonstrated promising correlations between quantitative CT data and physiological measurements in monitoring various pulmonary conditions, including Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease, Small Airway Diseases, and COVID-19 Pneumonia. CT scans are routinely performed on patients presenting with acute respiratory failure due to pneumonia. While imaging primarily evaluates lung parenchyma, additional tests such as spirometry are typically required to assess functional volumetric changes in the lungs. However, performing spirometric tests on critically ill patients is extremely challenging and often impractical, though theoretically possible. Previous research has successfully demonstrated correlations between quantitative CT measurements and disease prognosis, particularly in chronic lung diseases. These measurements have also been utilized in acute conditions such as COVID-19. In critically ill patients with acute respiratory failure, additional lung information can assist clinicians in prognostic prediction and facilitate earlier intervention. This study employs quantitative CT (qCT) measurements derived from CT attenuation histograms to examine the relationship between these parameters and disease prognosis in pneumonia patients with acute respiratory failure on invasive mechanical ventilation. These measurements include mean lung attenuation (MLA) and threshold-based volumetric measurements \[low-density volume (LDV), medium-density volume (MDV), high-density volume (HDV), the ratio of MDV to total lung volume (MDV/TLV), and the ratio of HDV to total lung volume (HDV/TLV)\]. Statistical analyses were planned to be conducted using IBM SPSS for Windows version 29.0 (IBM Corp., Armonk, NY, USA). The Kolmogorov-Smirnov test was intended to be employed to assess the normality assumption. Continuous variables were planned to be presented as median and interquartile range (IQR) in cases where the normality assumption was not met. Categorical variables were to be summarized as frequencies and percentages. Inter-group comparisons were planned to be performed using the Mann-Whitney U test. The relationships between categorical variables were intended to be examined using the Chi-square test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2025

Completed
Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

October 15, 2024

Last Update Submit

May 7, 2025

Conditions

Keywords

Quantitative Computed TomographyAcute Respiratory FailurePneumoniaCT Attenuation HistogramIntensive Care

Outcome Measures

Primary Outcomes (1)

  • This study utilizes quantitative CT (qCT) measurements obtained from CT attenuation histograms to investigate the relationship between these parameters and disease prognosis in pneumonia patients with acute respiratory failure

    Correlation between quantitative CT (qCT) parameters derived from CT attenuation histograms and disease prognosis in pneumonia patients with acute respiratory failure on invasive mechanical ventilation

    7 years

Study Arms (2)

Survivors

Cohort of patients who survived from the hospital until they were discharged.

Non-survivors

Cohort consisting of patients who died during hospitalization.

Eligibility Criteria

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

A retrospective review of 105 patients diagnosed with acute respiratory failure due to pneumonia, admitted to the general intensive care unit of Kocaeli University Medical Faculty between 2017 and 2024, was planned.

You may qualify if:

  • Patients with acute respiratory failure due to pneumonia, who had CT imaging upon admission and were not intubated at admission

You may not qualify if:

  • Patients under 18 years of age
  • Those with non-infectious etiology of acute respiratory failure
  • COVID-19 patients,
  • Those intubated during transfer to intensive care,
  • Lung cancer patients,
  • Those with known chronic lung disease,
  • Patients intubated during the first ICU examination
  • those whose intubation reason within the first 10 days was not acute respiratory failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Faculty of Medicine

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assistant Professor of Anesthesiology and Reanimation

Study Record Dates

First Submitted

October 15, 2024

First Posted

October 22, 2024

Study Start

November 1, 2024

Primary Completion

February 12, 2025

Study Completion

February 16, 2025

Last Updated

May 8, 2025

Record last verified: 2025-05

Locations