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

NCT02265198 | Completed

• 1 other identifier: BG03-018
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pulmonary Contusion; Respiratory Failure; ARDS

Keywords

Pulmonary Contusion; ARDS; Respiratory Failure

Outcome Measures

Primary Outcomes (2)

• 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

  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

  14 days

Secondary Outcomes (3)

• Presence of Tregs in BAL fluid

  14 days

• Presence of activated neutrophils in BAL fluid

  14 day

• Appearance of M2 macrophage phenotypes in BAL fluid

  14 day

Study Arms (4)

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bronchial Alveolar Lavage - Supernatant Blood-Serum

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Jason Hoth, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Peter E Morris, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 15, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 6, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)