Intraosseous Pressure Monitoring in Intensive Care Unit Patients

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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Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraosseous Device

Device

Other names: EZ-IO Needle Set and Driver

Primary outcomes

Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure

Time frame: 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.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

Vidacare Corporation

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Feb 11, 2014
Registry last updated: Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed