Relationship of Pulmonary Contusion to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Pneumonia, Hospital, Orthopedic, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 11/8/2017 |
| Start Date: | September 2014 |
| End Date: | March 2015 |
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
