Clinical trial NCT02059928: Intraosseous Pressure Monitoring in Intensive Care Unit Patients
Official title: Intraosseous Pressure Monitoring in Intensive Care Unit Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: fluid resuscitation
invasive pressure monitoring
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Vidacare Corporation
First posted: 2014-02-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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

Primary outcomes:
measure: Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure
timeFrame: Up to 12 hour data collection period
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
Study officials:
affiliation: Regions Hospital
name: Ralph J Frascone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regions Hospital
name: Josh Salzman, MA
role: STUDY_DIRECTOR
References: