Blood Pressure
Conditions
Keywords
fluid resuscitation, invasive pressure monitoring
Brief summary
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).
Interventions
DEVICEIntraosseous Device
Sponsors
Vidacare Corporation
HealthPartners Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years old * Admitted to the surgical intensive care units * Current central pressure monitoring through a central line * Patient currently intubated and sedated * Informed consent obtained from family member * English speaking patient
Exclusion criteria
* Known implanted devices in the humerus or tibia that prohibit placement of the intraosseous needle. * Known osteoporosis, avascular necrosis, or other bone pathology affecting bone healing. * Fracture or other significant injury to the tibia or humerus or surrounding musculature/tissue. * Inability to landmark IO placement due to excessive tissue over placement location. * Anticipated surgery within 12 hours of time of consent * Current infection at the placement site. * Previous, significant orthopedic procedure at the site * Pregnant or has the potential for being pregnant * Prisoner of the state * Minor (\< 18 years old) * Inability to obtain informed consent from family member * Non-English speaking patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure | Up to 12 hour data collection period | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intraosseous Device Placement Intraosseous device
Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Intraosseous Device Placement | — |
|---|---|---|
| Age, Continuous | 60 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 20 participants | — |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: Up to 12 hour data collection period
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intraosseous Device Placement | Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure | ratio as a percentage of IO SBP to cuff SBP | 34.5 percentage of IO pressure to cuff pressu |
| Intraosseous Device Placement | Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure | ratio as a percentage of IO DBP to cuff DBP | 40.5 percentage of IO pressure to cuff pressu |
| Intraosseous Device Placement | Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure | Ratio as a percentage of IO mean to cuff mean | 40.1 percentage of IO pressure to cuff pressu |