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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Anesthesia | Experimental | Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass. |
|
| Intravenous Anesthesia | Active Comparator | Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane | Drug | Volatile Anesthetic |
| |
| Propofol |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL) | Inflammatory mediator found in BAL fluid during lung inflammation | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Postoperative Pulmonary Complications | Composite endpoint of clinically relevant 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian O'Gara, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31151474 | Derived | O'Gara B, Subramaniam B, Shaefi S, Mueller A, Banner-Goodspeed V, Talmor D. Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS): a protocol for a randomized controlled trial. Trials. 2019 May 31;20(1):312. doi: 10.1186/s13063-019-3400-x. |
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49 Randomized
51 Enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Inhaled Anesthesia | Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass. Sevoflurane: Volatile Anesthetic |
| FG001 | Intravenous Anesthesia | Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass. Propofol: Intravenous Anesthetic |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhaled Anesthesia | Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass. Sevoflurane: Volatile Anesthetic |
| BG001 | Intravenous Anesthesia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL) | Inflammatory mediator found in BAL fluid during lung inflammation | Posted | Median | Inter-Quartile Range | pg/mL | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass |
|
During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inhaled Anesthesia | Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass. Sevoflurane: Volatile Anesthetic |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged intubation (greater than 48hrs) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian P. O'Gara | Beth Israel Deaconess Medical Center | 617-549-2974 | bpogara@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2018 | Mar 9, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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| Drug |
Intravenous Anesthetic |
|
|
| BAL Concentration of IL1b (pg/mL) | Inflammatory mediator found in BAL fluid during lung inflammation | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass |
| BAL Concentration of IL6 (pg/mL) | Inflammatory mediator found in BAL fluid during lung inflammation | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass |
| BAL Concentration of IL8 (pg/mL) | Inflammatory mediator found in BAL fluid during lung inflammation | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass |
| BAL Concentration of MCP1 (pg/mL) | Inflammatory mediator found in BAL fluid during lung inflammation | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass |
| BAL Concentration of sRAGE (pg/mL) | Biomarker of lung injury (RAGE - receptor for advance glycosylation end products) | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass |
| Physician Decision |
|
| Received intraoperative steroids |
|
| Unable to obtain lab samples |
|
| Unsafe to perform BAL |
|
Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass. Propofol: Intravenous Anesthetic |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | Pounds |
|
| Height | Mean | Standard Deviation | Inches |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Comorbidities | Count of Participants | Participants |
|
| ASA Score (American Society of Anesthesiologists) | Higher scores indicate worse preoperative comorbidity burden (on a range of 1-6). | Mean | Standard Deviation | scores on a scale. |
|
| ARISCAT Score | Higher scores indicate worse predicted risk for postoperative pulmonary complications (range 0-123). | Mean | Standard Deviation | scores on a scale |
|
|
|
| Secondary | Number of Patients With Postoperative Pulmonary Complications | Composite endpoint of clinically relevant pulmonary complications | Posted | Count of Participants | Participants | 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. |
|
|
|
| Secondary | BAL Concentration of IL1b (pg/mL) | Inflammatory mediator found in BAL fluid during lung inflammation | Posted | Median | Inter-Quartile Range | pg/mL | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass |
|
|
|
| Secondary | BAL Concentration of IL6 (pg/mL) | Inflammatory mediator found in BAL fluid during lung inflammation | Posted | Median | Inter-Quartile Range | pg/mL | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass |
|
|
|
| Secondary | BAL Concentration of IL8 (pg/mL) | Inflammatory mediator found in BAL fluid during lung inflammation | Posted | Median | Inter-Quartile Range | pg/mL | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass |
|
|
|
| Secondary | BAL Concentration of MCP1 (pg/mL) | Inflammatory mediator found in BAL fluid during lung inflammation | Posted | Median | Inter-Quartile Range | pg/mL | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass |
|
|
|
| Secondary | BAL Concentration of sRAGE (pg/mL) | Biomarker of lung injury (RAGE - receptor for advance glycosylation end products) | Posted | Median | Inter-Quartile Range | pg/mL | Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 18 |
| 18 |
| EG001 | Intravenous Anesthesia | Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass. Propofol: Intravenous Anesthetic | 1 | 22 | 0 | 22 | 22 | 22 |
| Failed extubation (re-intubated within 24hrs) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Reintubation (greater than 24hrs after extubation) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Infiltrate/consolidation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Brochospasm | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hypoxia (PaO2/FiO2 < 300) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory acidosis (PaCO2 > 45) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| Reintubation (greater than 24hrs after extubation) |
|
| Pulmonary edema |
|
| Pleural effusion |
|
| Atelectasis |
|
| Infiltrate/consolidation |
|
| Pneumothorax |
|
| ARDS |
|
| Pneumonia |
|
| Brochospasm |
|
| Exacerbation of chronic lung disease |
|
| Hypoxia (PaO2/FiO2 < 300) |
|
| Respiratory acidosis (PaCO2 > 45) |
|
| Any postoperative pulmonary complication |
|
| Difference |
|
| Difference |
|
| Difference |
|
| Difference |
|
| Difference |
|