Intraosseous Pressure Monitoring in Intensive Care Unit Patients

Not Applicable

Completed

• Conditions: Blood Pressure
• Interventions: Device: Intraosseous Device

• Registration Number: NCT02059928
• Lead Sponsor: HealthPartners Institute

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-11
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2017-02-20
• Results First Submitted QC: 2017-05-04
• Results First Posted: 2017-06-07
• Status Verified: 2018-04
• Last Update Submitted: 2018-06-05
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraosseous device placement	Intraosseous Device	Intraosseous device

Primary Outcome Measures

Name	Time	Method
Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure	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.

Trial Locations

Locations (1)

Regions Hospital; 🇺🇸 Saint Paul, Minnesota, United States