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).

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Device: Intraosseous Device

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraosseous device placement; Intraosseous device	Device: Intraosseous Device; Other Names: EZ-IO Needle Set and Driver

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: Vidacare Corporation
• Investigators: Principal Investigator: Ralph J Frascone, MD, Regions Hospital; Study Director: Josh Salzman, MA, Regions Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: February 10, 2014
• First Submitted That Met QC Criteria: February 10, 2014
• First Posted (Estimate): February 11, 2014

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: June 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: fluid resuscitation; invasive pressure monitoring
• Other Study ID Numbers: 13-149