Intraosseous Pressure Monitoring in Intensive Care Unit Patients

NCT02059928 | Completed Results DMC

• 1 other identifier: 13-149
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Blood Pressure

Keywords

fluid resuscitation; invasive pressure monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intraosseous device placement

EXPERIMENTAL

Intraosseous device

Device: Intraosseous Device

Interventions

Intraosseous Device DEVICE

Also known as: EZ-IO Needle Set and Driver

Intraosseous device placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead
• Vidacare Corporation: collaborator

Study Sites (1)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Results Point of Contact

• Title: Dr. Ralph J Frascone
• Organization: Health Partners

ralph.j.frascone@healthpartners.com

6512545304

Study Officials

• Ralph J Frascone, MD

  Regions Hospital

  PRINCIPAL INVESTIGATOR

• Josh Salzman, MA

  Regions Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 11, 2014
• Study Start: December 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 3, 2018
• Results First Posted: June 7, 2017

Record last verified: 2018-04

Locations

US (1)