Blood PressureNIBP vs IABPNCT00739700
Non-invasive Blood Pressure (BP) Monitoring Compared to A-Line BP Monitoring
An observational study of Blood Pressure, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Blood pressure cuffs (NIBP) are slowly replacing intra-arterial (IABP) measurement as the standard of care in the medical intensive care unit. There is little data to support this clinical normalization of deviance. This study aims to correlate NIBP with IABP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Medical Intensive Care Unit patients with intra-arterial blood pressure catheters will be enrolled. Blood pressure cuff measurements will be made in both arms and both legs.
Who may be able to join
- Arterial blood pressure line
Who cannot join
- Lack of arms and legs for cuff pressures
- Medical or surgical indication that might prevent use of blood pressure cuffs
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Accuracy and Precision of Oscillometric Blood Pressure Monitoring in the Arm, Calf and Thighs of Medical ICU Patients When Compared to Invasive Arterial Blood Pressure Monitoring
Blood pressure cuffs (NIBP) are slowly replacing intra-arterial (IABP) measurement as the standard of care in the medical intensive care unit. There is little data to support this clinical normalization of deviance. This study aims to correlate NIBP with IABP.
Read the detailed description
It has become standard practice in inpatient and intensive care settings to monitor systolic, diastolic and mean arterial blood pressure by oscillometric technique. Several studies have confirmed the accuracy and precision of the oscillometric technique in ambulatory patients at both the level of the brachial and radial arteries. Multiple clinical research studies have demonstrated that when blood pressures (systolic, diastolic and mean arterial pressures) determined by non-invasive blood pressure monitors (NIBP) from various manufacturers are compared to direct invasive arterial pressure monitors, the two values are on average within 5 mm Hg of each other. There is limited data in critically ill patients. To date, there are no studies evaluating the accuracy or precision of these devices in intensive care patients for alternative sites (calf, thigh). In addition, there are no large clinical studies evaluating oscillometric NIBP monitoring in a complex medical intensive care population with varying hemodynamics. The goal of this study is to validate the oscillometric technique in measurement of blood pressure in the calf and thigh regions when compared to a gold standard. We may also be able to evaluate more specifically which situations for our patient population the blood pressure will be accurately portrayed as compared with the arterial pressure tracing. It has possible clinical value in either validating non-invasive blood pressure monitoring and eliminating/decreasing the need for invasive arterial blood pressure monitoring. Our hypothesis is that NIBP in the medical intensive care patients is highly variable and not a reliable means of arterial blood pressure monitoring.
- Conditions
- Blood Pressure
- Keywords
- hemodynamics, blood pressure, blood pressure monitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | There is only one cohort of subjects, the critically ill. The NIBP will be correlated with the IABP in each subject. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between NIBP and IABP. NIBP is measured in both upper arms, both wrists, both thighs, and both ankles.
Measured: All NIBP's are measured within 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startJun 2007
- Primary completionDec 2009
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arjun B Chatterjee, MD, MS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739700
- Sponsor's protocol ID
- IRB00001777
- Acronym
- NIBP vs IABP
- Status last verified
- Jan 2017
- First submitted
- 20 Aug 2008
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A requestor must have local IRB approval and funding to support a request of this data. It will be provided de-identified and shared authorship is required.
Publications
Bur A, Hirschl MM, Herkner H, Oschatz E, Kofler J, Woisetschlager C, Laggner AN. Accuracy of oscillometric blood pressure measurement according to the relation between cuff size and upper-arm circumference in critically ill patients. Crit Care Med. 2000 Feb;28(2):371-6. doi: 10.1097/00003246-200002000-00014.
PubMed 10708169Bur A, Herkner H, Vlcek M, Woisetschlager C, Derhaschnig U, Delle Karth G, Laggner AN, Hirschl MM. Factors influencing the accuracy of oscillometric blood pressure measurement in critically ill patients. Crit Care Med. 2003 Mar;31(3):793-9. doi: 10.1097/01.CCM.0000053650.12025.1A.
PubMed 12626986Davis JW, Davis IC, Bennink LD, Bilello JF, Kaups KL, Parks SN. Are automated blood pressure measurements accurate in trauma patients? J Trauma. 2003 Nov;55(5):860-3. doi: 10.1097/01.TA.0000092686.91877.DE.
PubMed 14608157Chatterjee A, DePriest K, Blair R, Bowton D, Chin R. Results of a survey of blood pressure monitoring by intensivists in critically ill patients: a preliminary study. Crit Care Med. 2010 Dec;38(12):2335-8. doi: 10.1097/CCM.0b013e3181fa057f.
PubMed 20890190DePriest KL, Cauthen CG, Perry CD, Blair RA, Chatterjee A, Bowton D, Chin R. Do oscillatory blood pressure measurements in upper and lower extremities correlate in patients in the intensive care unit? Chest. 2008; 134(4_Meeting Abstracts): 119001.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Precision of Oscillometric Blood Pressure Monitoring in the Arm, Calf and Thighs of Medical ICU Patients When Compared to Invasive Arterial Blood Pressure Monitoring
- ClinicalTrials.gov ID
- NCT00739700
- Acronym / sponsor ID
- NIBP vs IABP / IRB00001777
- Conditions
- Blood Pressure
- Keywords
- hemodynamics, blood pressure, blood pressure monitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jun 2007 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Blood pressure cuffs (NIBP) are slowly replacing intra-arterial (IABP) measurement as the standard of care in the medical intensive care unit. There is little data to support this clinical normalization of deviance. This study aims to correlate NIBP with IABP.
Detailed description
It has become standard practice in inpatient and intensive care settings to monitor systolic, diastolic and mean arterial blood pressure by oscillometric technique. Several studies have confirmed the accuracy and precision of the oscillometric technique in ambulatory patients at both the level of the brachial and radial arteries. Multiple clinical research studies have demonstrated that when blood pressures (systolic, diastolic and mean arterial pressures) determined by non-invasive blood pressure monitors (NIBP) from various manufacturers are compared to direct invasive arterial pressure monitors, the two values are on average within 5 mm Hg of each other. There is limited data in critically ill patients. To date, there are no studies evaluating the accuracy or precision of these devices in intensive care patients for alternative sites (calf, thigh). In addition, there are no large clinical studies evaluating oscillometric NIBP monitoring in a complex medical intensive care population with varying hemodynamics. The goal of this study is to validate the oscillometric technique in measurement of blood pressure in the calf and thigh regions when compared to a gold standard. We may also be able to evaluate more specifically which situations for our patient population the blood pressure will be accurately portrayed as compared with the arterial pressure tracing. It has possible clinical value in either validating non-invasive blood pressure monitoring and eliminating/decreasing the need for invasive arterial blood pressure monitoring. Our hypothesis is that NIBP in the medical intensive care patients is highly variable and not a reliable means of arterial blood pressure monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –There is only one cohort of subjects, the critically ill. The NIBP will be correlated with the IABP in each subject. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical Intensive Care Unit patients with intra-arterial blood pressure catheters will be enrolled. Blood pressure cuff measurements will be made in both arms and both legs.
Key inclusion criteria (1 listed)
- Arterial blood pressure line
Key exclusion criteria (2 listed)
- Lack of arms and legs for cuff pressures
- Medical or surgical indication that might prevent use of blood pressure cuffs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between NIBP and IABP. NIBP is measured in both upper arms, both wrists, both thighs, and both ankles.
Time frame: All NIBP's are measured within 10 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Background: PubMed 10708169Bur A, Hirschl MM, Herkner H, Oschatz E, Kofler J, Woisetschlager C, Laggner AN. Accuracy of oscillometric blood pressure measurement according to the relation between cuff size and upper-arm circumference in critically ill patients. Crit Care Med. 2000 Feb;28(2):371-6. doi: 10.1097/00003246-200002000-00014.
- Background: PubMed 12626986Bur A, Herkner H, Vlcek M, Woisetschlager C, Derhaschnig U, Delle Karth G, Laggner AN, Hirschl MM. Factors influencing the accuracy of oscillometric blood pressure measurement in critically ill patients. Crit Care Med. 2003 Mar;31(3):793-9. doi: 10.1097/01.CCM.0000053650.12025.1A.
- Background: PubMed 14608157Davis JW, Davis IC, Bennink LD, Bilello JF, Kaups KL, Parks SN. Are automated blood pressure measurements accurate in trauma patients? J Trauma. 2003 Nov;55(5):860-3. doi: 10.1097/01.TA.0000092686.91877.DE.
- Background: PubMed 20890190Chatterjee A, DePriest K, Blair R, Bowton D, Chin R. Results of a survey of blood pressure monitoring by intensivists in critically ill patients: a preliminary study. Crit Care Med. 2010 Dec;38(12):2335-8. doi: 10.1097/CCM.0b013e3181fa057f.
- BackgroundDePriest KL, Cauthen CG, Perry CD, Blair RA, Chatterjee A, Bowton D, Chin R. Do oscillatory blood pressure measurements in upper and lower extremities correlate in patients in the intensive care unit? Chest. 2008; 134(4_Meeting Abstracts): 119001.
- Individual participant dataSharing planned: Yes. A requestor must have local IRB approval and funding to support a request of this data. It will be provided de-identified and shared authorship is required.
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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.
Arjun B Chatterjee, MD, MS principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Wake Forest University Health Sciences 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 1 inclusion and 2 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 8 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between NIBP and IABP. NIBP is measured in both upper arms, both wrists, both thighs, and both ankles. (time frame: All NIBP's are measured within 10 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00739700, which also lists 5 linked publications.
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 8 Nov 2017.