Pulmonary ContusionNCT02265198
Relationship of Pulmonary Contusion to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome
An observational study of Pulmonary Contusion and Respiratory Failure, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pulmonary Contusion, Respiratory Failure, ARDS
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Contusion, Respiratory Failure, ARDS
- Keywords
- Pulmonary Contusion, ARDS, Respiratory Failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Volume of Pulmonary Contusion on CT scan
Measured volume of pulmonary contusion on CT scan correlates with increase in ventilator free days, ICU days, hospital days, and mortality
Measured: 14 days
Volume of serum inflammatory mediator levels in BAL fluid
Volume of serum inflammatory mediator levels correlates with increase in ventilator free days, ICU days, hospital days, and mortality
Measured: 14 days
Secondary outcomes (3)
Presence of Tregs in BAL fluid
Measure presence of Tregs in BAL (% or absolute) to determine if positively correlated with reduced lung injury duration (increase in ventilator free days)
Measured: 14 days
Presence of activated neutrophils in BAL fluid
measure neutrophil phenotypes in numbers to determine correlation with vent free days and mortality
Measured: 14 day
Appearance of M2 macrophage phenotypes in BAL fluid
measure macrophage phenotype (M1 or M2) numbers and percent to determine correlation with vent free days and mortality
Measured: 14 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ContusionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Hoth, MD, Principal investigator, Wake Forest University Health SciencesPeter E Morris, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265198
- Sponsor's protocol ID
- BG03-018
- Status last verified
- Oct 2016
- First submitted
- 7 Oct 2014
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Pulmonary Contusion Morphology to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT02265198
- Acronym / sponsor ID
- BG03-018
- Conditions
- Pulmonary Contusion, Respiratory Failure, ARDS
- Keywords
- Pulmonary Contusion, ARDS, Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
3 secondary outcomes
Presence of Tregs in BAL fluid
Time frame: 14 days
Presence of activated neutrophils in BAL fluid
Time frame: 14 day
Appearance of M2 macrophage phenotypes in BAL fluid
Time frame: 14 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Contusion
Not yet recruitingObservational study
Combined Lung and Diaphragmatic Ultrasound to Predict Respiratory Failure in Blunt Chest Trauma
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Not yet recruitingObservational study
Non-Invasive Dynamic Monitoring-Guided Oscillation and Lung Expansion for Airway Clearance in Severe Blunt Chest Trauma: A Clinical Study
Blunt Chest Trauma
Recruiting
Effects of Non-invasive Ventilation Therapies on the Lung in Hypoxemic Chest Trauma Patients
Lung Trauma, Lung Contusion
RecruitingObservational study
AI in the Identification of Lung Contusions Through Chest Radiological Examination in Blunt Thoracic Trauma
Lung Contusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Hoth, MD principal investigator
Wake Forest University Health Sciences
Peter E Morris, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Contusion and Respiratory Failure, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of Pulmonary Contusion on CT scan (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.