Various types of biologic samples will be obtained from participants enrolled in consortium investigations. Please see table below for complete details.
Ambulatory participants with alcohol use disorders and healthy controls. Enrolled individuals will have sampling conducted in a clinical translational research center (CTRC) or similarly controlled setting. Bronchoscopy with bronchoalveolar lavage (BAL) and brushings will be performed by the principal investigator or her co-investigators, all of whom are pulmonologists.
Critically ill patients with respiratory failure and with burn injury. Enrolled patients will have data collection and sampling performed in an ICU setting, including information regarding alcohol history and drug use using validated questionnaires. Historical information will generally be collected from a proxy or surrogate of the patient, and will be confirmed by patients once capacity is regained. Data collection, as well as biologic sampling will be performed by trained personnel. Bronchoscopy will be performed by clinical personnel who have experience in performing this procedure.
Description of participant or patient types, and planned sample collection, after screening and informed consent process.
|Single bronchoscopy protocol||Longitudinal bronchoscopy protocol||Burn patient protocol||Respiratory failure patient protocol|
|Participant type(s)||AUDs & Pair-matched controls||AUD participants||Burn ICU patients, ± AUDs||Respiratory failure patients in ICU, ± AUDs|
|Demographic, AUD, smoking (cigarettes and /or cannabis) data collection||Yes, from participant||Yes, from participant||Yes, from health care proxy, confirmed by patient||Yes, from health care proxy, confirmed by patient|
|Length of protocol||1 (controls) to 3 (AUDs) days (inpatient)||9 days (inpatient)|
14 or 21 days (outpatient)
|Varies (inpatient)||Varies (inpatient)|
|a Blood (plasma, serum, buffy coat, peripheral blood mononuclear cells)||On Day 1||On Days 1, 4, and 7||Within 24 hours of injury, @Days 3-5, and Days 7-10||Within 24 hours of mechanical ventilation, @Days 3-5, and Days 7-10|
|b Bronchoscopic samples||BAL, cytologic brushings x 3 on Day 1||BAL, cytologic brushings x 3 on Day 1; repeat on day 7, 14, or 21||BAL, mini-BAL, or tracheal aspirate <48 hours post-intubation||BAL, mini-BAL, or tracheal aspirate <48 hours post-intubation|
|Other sample types||Oral wash and nasal epithelial brushing on Day 1||Oral wash and nasal epithelial brushing on Days 1 & 7||Nasal epithelial brushing||Nasal epithelial brushing|
|a Blood volume at each time point=35cc. b BAL yield for ambulatory participants=60cc with 10-20 million WBCs; for critically ill patients=10-20 cc with 10-20 million WBCs. Mini BAL yield=1-4 cc with 1-10 million WBCs.|