Intraosseous Pressure Monitoring in Intensive Care Unit Patients

NCT ID: NCT02059928

Last Updated: 2018-07-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Blood Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intraosseous device placement

Intraosseous device

Group Type EXPERIMENTAL

Intraosseous Device

Intervention Type DEVICE

Interventions

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Intraosseous Device

Intervention Type DEVICE

Other Intervention Names

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EZ-IO Needle Set and Driver

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vidacare Corporation

INDUSTRY

Sponsor Role collaborator

HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ralph J Frascone, MD

Role: PRINCIPAL_INVESTIGATOR

Regions Hospital

Josh Salzman, MA

Role: STUDY_DIRECTOR

Regions Hospital

Locations

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Regions Hospital

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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13-149

Identifier Type: -

Identifier Source: org_study_id

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