Blood PressureNCT02059928
Intraosseous Pressure Monitoring in Intensive Care Unit Patients
A study testing Intraosseous Device in people with Blood Pressure, run by HealthPartners Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Intraosseous Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Intraosseous Device
- Keywords
- fluid resuscitation, invasive pressure monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraosseous DeviceDevice
Also called EZ-IO Needle Set and Driver
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous device placement | Experimental | Intraosseous device Receives: Device: Intraosseous Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 hour data collection period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Vidacare Corporation
- Responsible party
- Sponsor
- Investigators
- Ralph J Frascone, MD, Principal investigator, Regions HospitalJosh Salzman, MA, Study director, Regions Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059928
- Sponsor's protocol ID
- 13-149
- Status last verified
- Apr 2018
- First submitted
- 10 Feb 2014
- Last updated
- 3 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraosseous Pressure Monitoring in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT02059928
- Acronym / sponsor ID
- 13-149
- Conditions
- Blood Pressure
- Keywords
- fluid resuscitation, invasive pressure monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Vidacare Corporation
- Study start
- Dec 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Posted 7 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraosseous device placement | Experimental | Device: Intraosseous DeviceIntraosseous device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraosseous DeviceAlso: EZ-IO Needle Set and Driver | Device | Intraosseous device placement |
Primary outcome
Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph J Frascone, MD principal investigator
Regions Hospital
Josh Salzman, MA study director
Regions Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraosseous Device in people with Blood Pressure, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure (time frame: Up to 12 hour data collection period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.