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| Name | Class |
|---|---|
| Vidacare Corporation | INDUSTRY |
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In emergency situations, access to the venous system is essential in order to administer fluids and medication and to monitor patients. When peripheral veins are difficult to access or the patient's condition requires certain medications, or monitoring, central venous catheters (CVC) are inserted. CVC placement introduces a much higher level of risk compared to peripheral catheters. The technique of intraosseous (IO) infusion has been used by healthcare professionals for several decades, but recently has gained wide popularity in the emergency care settings. This technique allows providers to secure a needle in the bony matrix at the ends of long bones (tibia and humerus) and infuse fluids and medications into the intramedullary space. The ability to monitor a patient's blood pressure through an intraosseous needle is unknown. The primary objective of this study is to describe the relationship (ratio) of intraosseous pressure (IOP) values to standard pressure values, including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and central venous pressure (CVP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraosseous device placement | Experimental | Intraosseous device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraosseous Device | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure | External cuff pressure readings were recorded every 15 minutes, and IO pressure data obtained via pressure transducer was recorded continuously for up to 12 hours. IO systolic, diastolic, and mean pressure (IO SBP, IO DBP, IO Mean) readings were summarized for the minute before and minute following an external cuff pressure reading. The ratios as a percentage of IO pressures to external cuff pressures (IO Systolic Blood Pressure / Cuff SBP; IO DBP / Cuff DBP; IO Mean / Cuff Mean) were calculated. | Up to 12 hour data collection period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph J Frascone, MD | Regions Hospital | Principal Investigator |
| Josh Salzman, MA | Regions Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intraosseous Device Placement | Intraosseous device Intraosseous Device pressure measurement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Twenty patients were enrolled between January 2014 and May 2015
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| ID | Title | Description |
|---|---|---|
| BG000 | Intraosseous Device Placement | Intraosseous device Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure | External cuff pressure readings were recorded every 15 minutes, and IO pressure data obtained via pressure transducer was recorded continuously for up to 12 hours. IO systolic, diastolic, and mean pressure (IO SBP, IO DBP, IO Mean) readings were summarized for the minute before and minute following an external cuff pressure reading. The ratios as a percentage of IO pressures to external cuff pressures (IO Systolic Blood Pressure / Cuff SBP; IO DBP / Cuff DBP; IO Mean / Cuff Mean) were calculated. | Inclusion criteria included: age ≥ 18 year old, presence of an IO placed by EMS or in the Emergency Department, and planned admission to the Medical or Surgical Intensive Care Unit. Patients were excluded if they had anticipated surgery within 12 hours of IO placement, ongoing infection at the placement site. | Posted | Number | percentage of IO pressure to cuff pressu | Up to 12 hour data collection period |
|
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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 | Intraosseous Device Placement | Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ralph J Frascone | Health Partners | 6512545304 | ralph.j.frascone@healthpartners.com |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Intraosseous Device Placement |
Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
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