Intraosseous Pressure Monitoring in Intensive Care Unit Patients

Blood Pressure Clinical Trial

Official title:

Intraosseous Pressure Monitoring in Intensive Care Unit Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059928
• Other study ID #: 13-149
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: May 2015

Study information

• Verified date: April 2018
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• Intraosseous Device

Locations

Country	Name	City	State
United States	Regions Hospital	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	Vidacare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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