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The main goals of the study are as follows: (1) to determine the correlation between pain management using continuous infusion of local anesthetics and the incidence of pneumonia and surgical infection in cardiac surgery patients; and (2) to evaluate the relationship between hospital-acquired pneumonia and surgical infection and patient outcomes, including length of hospital stay.
Nosocomial infections are recognized as an important cause of increased patient morbidity and mortality. The reported prevalence for nosocomial infections most commonly ranges from 5 to 20%, but can be significantly greater among patients requiring intensive care. The most common sites of hospital acquired infection include the lung, urinary tract, surgical wounds, and the bloodstream. Patients undergoing cardiac surgery appear to be at increased risk for the development of nosocomial infections due to the presence of multiple surgical wounds (chest and lower extremity incisions), frequent postoperative utilization of invasive devices (i.e. central venous catheters, chest drains, intra-aortic balloon counter pulsation, pulmonary artery catheter), and the common use of prophylactic or empiric antibiotics in the perioperative period. In the cardiac surgical postoperative period, nosocomial infections have been found to be associated with prolonged length of stay (LOS) in the ICU and total hospitalization, development of multiorgan dysfunction, and increased hospital mortality. Nosocomial Pneumonia (NP) is in fact the leading cause of mortality due to hospital-acquired infections. Patients with Ventilator Associated Pneumonia (VAP) have been found in various studies to have significantly higher mortality rates than those without VAP, with ranges of 20.2-45.5% and 8.5-32.2%, respectively. Strategies that both reduce postoperative pain and sedation have the potential to reduce postoperative pneumonia by allowing earlier extubation and more effective pulmonary toilet post-extubation. Non-opioid pain management has the potential to reduce NP rates because of superior pain management, as well as the reduction in opioids required, and the concomitant avoidance of opioid side effects. The clinical and financial consequences of NP justify aggressively pursuing strategies aimed at prevention. Specifically, these strategies are targeted at reducing the incidence of NP by addressing the modifiable risk factors including prolonged endotracheal intubation and ventilator support, sedation, and long hospital LOS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Sternal Block | Experimental | Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system |
|
| Opioid based analgesia | Active Comparator | Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Sternal Block | Device | Elastomeric Pump for Continuous Infusion of Local Anesthetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Acquired Pneumonia | Pneumonia diagnosed during hospitalization | 30 days postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Infection | surgical site infection diagnosed within 30 days post surgery | 30 days postoperative |
| Hospital Length of Stay | time (days) from date of admission to discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Husain, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincents East | Birmingham | Alabama | 35235 | United States | ||
| Christianna Care Health System |
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Sternal Block | Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic |
| FG001 | Opioid Based Analgesia | Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics Opioid based analgesia: Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Sternal Block | Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic |
| BG001 | Opioid Based Analgesia |
| 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 | Hospital Acquired Pneumonia | Pneumonia diagnosed during hospitalization | all randomized subjects | Posted | Number | participants | 30 days postoperative |
|
30 days
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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 | Continuous Sternal Block | Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director Clinical Research | Halyard Health | 5132538033 | alan.dine@hyh.com |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D010323 | Passive Cutaneous Anaphylaxis |
| ID | Term |
|---|---|
| D012882 | Skin Tests |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Opioid based analgesia | Drug | Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN |
|
|
| primary admission |
| Newark |
| Delaware |
| 19713 |
| United States |
| University of Kentucky Medical Center | Lexington | Kentucky | 40506 | United States |
| Ochsner | New Orleans | Louisiana | 70121 | United States |
| Cape Fear valley Hospital | Fayetteville | North Carolina | 28304 | United States |
| Medcentral Hospital | Mansfield | Ohio | 44903 | United States |
| Methodist Hospital | Houston | Texas | 77030 | United States |
| Waukesha Medical Center | West Allis | Wisconsin | 53227 | United States |
Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics Opioid based analgesia: Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Surgical Site Infection | surgical site infection diagnosed within 30 days post surgery | all randomized subjects | Posted | Number | participants | 30 days postoperative |
|
|
|
| Secondary | Hospital Length of Stay | time (days) from date of admission to discharge | all randomized subjects | Posted | Mean | Standard Deviation | days | primary admission |
|
|
|
| 0 |
| 321 |
| 0 |
| 321 |
| EG001 | Opioid Based Analgesia | Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics Opioid based analgesia: Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN | 0 | 326 | 0 | 326 |
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| D014946 |
| Wound Infection |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D000937 | Antigen-Antibody Reactions |
| D055633 | Immune System Phenomena |