Anesthetics to Prevent Lung Injury in Cardiac Surgery
- Conditions
- Inflammatory Lung InjuryIschemia-Reperfusion Lung InjuryPostoperative Pulmonary Complications
- Interventions
- Registration Number
- NCT02918877
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- Brief Summary
The purpose of this study is to investigate whether the use of inhaled anesthetics, compared to intravenous anesthetics, can affect the amount of lung inflammation and postoperative respiratory complications seen after cardiac surgery.
- Detailed Description
Randomized, controlled trial involving 45 adult patients undergoing cardiac surgery with cardiopulmonary bypass. Patients will be randomized to receive either inhaled anesthesia with sevoflurane or total intravenous anesthesia (TIVA) with propofol for the maintenance phase of their cardiac anesthetic. Assessment of lung inflammation will take place using fiberoptic bronchoscopic sampling of lung fluid as well as serum collection before and after exposure to cardiopulmonary bypass, and the incidence of compositive postoperative pulmonary complications will take place in the postoperative period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- Adult patients (age 18+)
- Undergoing cardiac surgery with cardiopulmonary bypass
- Emergency surgery
- History of severe COPD, emphysema, or ILD
- Recent (<2wk) or current use of systemic glucocorticoids
- Prior history of pneumothorax
- Allergy/contraindication to intravenous anesthetics
- Personal or family history of malignant hyperthermia or high risk for malignant hyperthermia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inhaled Anesthesia Sevoflurane Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass. Intravenous Anesthesia Propofol Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
- Primary Outcome Measures
Name Time Method Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL) Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass Inflammatory mediator found in BAL fluid during lung inflammation
- Secondary Outcome Measures
Name Time Method Number of Patients With Postoperative Pulmonary Complications Assessed daily, beginning on the first day after surgery, until hospital discharge or death. On average at our institution, most patients are discharged within 7 days so this is the expected time frame for follow up. Composite endpoint of clinically relevant pulmonary complications
BAL Concentration of IL1b (pg/mL) Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass Inflammatory mediator found in BAL fluid during lung inflammation
BAL Concentration of IL6 (pg/mL) Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass Inflammatory mediator found in BAL fluid during lung inflammation
BAL Concentration of IL8 (pg/mL) Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass Inflammatory mediator found in BAL fluid during lung inflammation
BAL Concentration of MCP1 (pg/mL) Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass Inflammatory mediator found in BAL fluid during lung inflammation
BAL Concentration of sRAGE (pg/mL) Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass Biomarker of lung injury (RAGE - receptor for advance glycosylation end products)
Trial Locations
- Locations (1)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States