Relationship of Pulmonary Contusion to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome

November 2, 2017 updated by: Wake Forest University Health Sciences

Relationship of Pulmonary Contusion Morphology to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome

Pulmonary contusion (PC) is a significant problem after blunt trauma that may often lead to acute respiratory distress syndrome (ARDS) and in some patients, death. Although the pathophysiology is incompletely understood, it is clear that there is a biochemical process involving changes in the inflammatory milieu after contusion which occurs in addition to simple direct mechanical injury to the lung. The relationship of severity of contusion on imaging, disturbances in the inflammatory phenotype, and outcome is unknown. This is a prospective, observational study which will evaluate the size and severity of contusion as measured on chest computed tomography (CT). Inflammatory mediators will be measured in the bronchoalveolar lavage (BAL) and in the serum of patients with pulmonary contusion to define the inflammatory nature of the post-contusion lung. The degree of abnormality within the inflammatory parameters will be correlated with lung contusion size and subsequent patient outcomes. These data will be compared to other patient groups: 1) Trauma patients without chest injury who are mechanically ventilated; 2) Uninjured patients undergoing elective surgical procedures that will require intubation and mechanical ventilation; 3) Patients in the Medical ICU who are mechanically ventilated with acute respiratory failure.

The hypothesis tested within this study is resolution of lung injury is dependent upon the presence of Tregs in the alveolar space.

Study Overview

Status

Completed

Detailed Description

The study will be conducted at Wake Forest University Baptist Medical Center and will enroll 40 patients in the PC study group, 20 patients in each control group, and 20 MICU patients. Recruitment will occur over two years. The sample size was determined by identifying the mean number of patients with PC admitted (38) to WFUBMC per year. Using Whittemore's formula, this sample size will be adequate to detect a significant odds ratio of 5 (alpha <0.05) with respect to increase in acute lung injury or ARDS risk in patients with > 20 % total lung volume contusion with approximately 85% power. The odds ratio for this population in developing acute lung injury or ARDS in a previous study was 16.666. Eligible subjects for study group will be patients with PC on admission CT; eligible subjects for control group #1 (CG1) are non-injured patients without PC undergoing a standard general surgical procedure; eligible subjects for control group #2 (CG2) are non-chest, non-PC trauma patients who are admitted intubated to the trauma ICU; eligible MICU subjects are patients on mechanical ventilation admitted to the Medical ICU with acute respiratory failure.

Informed consent for study group, CG2, and the MICU group will generally be obtained from family members as most patients will be unconscious or sedated. If the patient is alert, the study will be explained to both the patient and family. Informed consent for CG1 will be obtained from the patient and family members in Surgery Clinic prior to elective procedures. An initial blood sample will be obtained on all persons in the study group, CG2, and, if the patient is ventilated, a BAL will be obtained after signing of the informed consent by the patient or LAR. Blood samples and pulmonary samples will be obtained on CG1 patients after obtaining signed informed consent, in the operating theater, after they are sedated and intubated, though before their elective procedure. Blood and pulmonary samples will be obtained from MICU subjects after obtaining signed informed consent.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted at Wake Forest University Baptist Medical Center and will enroll 40 patients in the PC study group, 20 patients in each control group, and 20 MICU patients. Eligible subjects for study group will be patients with PC on admission CT; eligible subjects for control group #1 (CG1) are normal patients without PC undergoing a standard general surgical procedure; eligible subjects for control group #2 (CG2) are non-chest, non-PC trauma patients who are admitted intubated to the trauma ICU; eligible MICU subjects are patients on mechanical ventilation admitted to the Medical ICU with acute respiratory failure.

Description

Inclusion Criteria:

  • Age > 15 years old
  • Chest trauma patients
  • Medical ICU patients with respiratory failure
  • Elective surgery patients
  • Trauma or surgical ICU patients on ventilators without chest trauma/pulmonary contusion

Exclusion Criteria:

  • Age 15 years and younger
  • Pregnant women
  • Subjects with multiple myeloma, pheochromocytoma, homozygous sickle cell disease, or thyroid disorders
  • Traumatic brain injury requiring intracranial pressure monitoring
  • Moribund status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PC Group
patients with Pulmonary Contusion on chest computed tomography (CT)
Control Group 1
Uninjured patients undergoing elective surgical procedures that will require intubation and mechanical ventilation
Control Group 2
Trauma patients without chest injury who are mechanically ventilated
MICU group
Patients in the Medical ICU who are mechanically ventilated with acute respiratory failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of Pulmonary Contusion on CT scan
Time Frame: 14 days
Measured volume of pulmonary contusion on CT scan correlates with increase in ventilator free days, ICU days, hospital days, and mortality
14 days
Volume of serum inflammatory mediator levels in BAL fluid
Time Frame: 14 days
Volume of serum inflammatory mediator levels correlates with increase in ventilator free days, ICU days, hospital days, and mortality
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Tregs in BAL fluid
Time Frame: 14 days
Measure presence of Tregs in BAL (% or absolute) to determine if positively correlated with reduced lung injury duration (increase in ventilator free days)
14 days
Presence of activated neutrophils in BAL fluid
Time Frame: 14 day
measure neutrophil phenotypes in numbers to determine correlation with vent free days and mortality
14 day
Appearance of M2 macrophage phenotypes in BAL fluid
Time Frame: 14 day
measure macrophage phenotype (M1 or M2) numbers and percent to determine correlation with vent free days and mortality
14 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jason Hoth, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 7, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

October 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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