Blood PressureNCT01627470
Comparison of Continuous Non-invasive Pressure Device Versus Invasive Pressure Measurement During Prehospital Emergency
An observational study of Blood Pressure, run by Robert Hanss at 1 site in Germany.
Trial summary
The aim of the study is to evaluate the accuracy of continuous non-invasive AP monitoring (CNAP) compared to simultaneous IBP measurement in intensive care patients undergoing a transport in the ambulance car. 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?
- CNAP-Monitor
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Aug 2012
- 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: ICU Patients with established arterial pressure measurement
Who may be able to join
- Patients willing and capable of giving informed consent or with legal agents willing of giving informed consent
- Patients undergoing a transport from the intensive care unit to another institution with the ambulance car
- Patients where the IBP cannula was already placed on the intensive care unit
- Patients where IBP cannula, and CNAP upper arm cuff can be placed on the same arm, and CNAP finger cuff can be placed on the contra-lateral arm
- Intact perfusion of both arm evidenced by a negative Allen's test
- Age 18 years and above
- ASA I-IV
- Weight >= 40 and <= 180 kg, BMI < 35
Who cannot join
- Patients with history of neurological, neuromuscular seizure
- Patients where IBP cannula cannot be placed in the radial artery
- Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm)
- Patients with history of arrhythmias
- Edematous patients
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Schleswig-Holstein - Campus Kiel
Kiel, 24105
Florian Reifferscheid, Dr. med., +49 431 597 2991, reifferscheid@uksh.de
About this study
Official title: Evaluation of a Continuous Non-invasive Arterial Pressure Device in Comparison With Invasive Pressure Measurement During Out-of-hospital Emergency
The aim of the study is to evaluate the accuracy of continuous non-invasive AP monitoring (CNAP) compared to simultaneous IBP measurement in intensive care patients undergoing a transport in the ambulance car.
Since CNAP finger blood pressure is calibrated to NBP level, a systematic bias between IBP and CNAP as described by a recent FDA meta analysis [ ] is expected. The most important factor of CNAP system performance is its ability to accurately track blood pressure changes. Thus, the purpose of this investigation is to show that the bias between CNAP and IBP falls within the expected range and that blood pressure alterations are detected instantaneously.
Read more
The endpoints of the study are:
- The agreement of systolic, diastolic and mean CNAP and IBP readings determined on a beat-to-beat basis during:
- Takeover of the patient on the intensive care unit,
- Transport of the patient from the intensive care unit to the ambulance car
- Transport of the patient in the ambulance car
- The agreement of systolic, diastolic and mean CNAP and IBP blood pres-sure changes determined on a beat-to-beat basis during:
- Takeover of the patient on the intensive care unit,
- Transport of the patient from the intensive care unit to the ambulance car
- Transport of the patient in the ambulance car
The beat-to-beat readings of CNAP and IBP will be automatically recorded electronically on a memory card in the transport monitor. CNAP data will additionally be recorded directly on the CNAP Monitor with a memory stick. Safety will be assessed by clinical observations as well as adverse events (AE) recording.
Read the detailed description
Arterial pressure (AP) is one of the most important physiological variables. Particularly in emergency medicine, AP needs to be monitored repeatedly or even better, continuously. This is usually done using an oscillometric pressure device (NIBP). A number of studies emphasise the importance of continuous AP monitoring as more than 20% of all hypotensive episodes may be missed by NIBP and another 20% are detected with delay. Prolonged hypotension precedes 56% of perioperative cardiac arrests and is associated with a significant increase of the 1-year mortality rate, indicating that NBP monitoring especially in patients with cardiovascular diseases might be insufficient independent from the clinical setting. Recently, a monitor for continuous non-invasive AP monitoring (CNAP™ Monitor 500) was introduced. It was shown that during procedures with high risk of hypotension NIBP missed significant more hypotensive episodes than CNAP. At the moment we have no evidence of the performance of CNAP in the preclinical emergency medicine. The evaluation against the gold standard of invasive pressure measurement in this study will help us to evaluate the performance of CNAP in the preclinical setting.
- Conditions
- Blood Pressure
- Being tested
- CNAP-Monitor
- Keywords
- non-invasive arterial pressure, emergency, intensive care
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNAP-MonitorDevice
Also called CNAP, Continuous non-invasive arterial blood pressure recording
Continuous non-invasive arterial blood pressure recording
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Emergency Patients with applied arterial blood pressure measurement Receives: Device: CNAP-Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
agreement with invasive blood pressure
beat-to-beat readings of CNAP and IBP
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Hanss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Hanss, University Hospital Schleswig-Holstein
- Investigators
- Robert Hanss, PD Dr., Study chair, UKSH-Campus Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627470
- Sponsor's protocol ID
- CNAP-ITW
- Status last verified
- Jun 2012
- First submitted
- 2 Nov 2011
- Last updated
- 25 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Continuous Non-invasive Arterial Pressure Device in Comparison With Invasive Pressure Measurement During Out-of-hospital Emergency
- ClinicalTrials.gov ID
- NCT01627470
- Acronym / sponsor ID
- CNAP-ITW
- Conditions
- Blood Pressure
- Keywords
- non-invasive arterial pressure, emergency, intensive care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Robert HanssUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 25 Jun 2012 (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.
The aim of the study is to evaluate the accuracy of continuous non-invasive AP monitoring (CNAP) compared to simultaneous IBP measurement in intensive care patients undergoing a transport in the ambulance car.
Since CNAP finger blood pressure is calibrated to NBP level, a systematic bias between IBP and CNAP as described by a recent FDA meta analysis [ ] is expected. The most important factor of CNAP system performance is its ability to accurately track blood pressure changes. Thus, the purpose of this investigation is to show that the bias between CNAP and IBP falls within the expected range and that blood pressure alterations are detected instantaneously.
The endpoints of the study are:
- The agreement of systolic, diastolic and mean CNAP and IBP readings determined on a beat-to-beat basis during:
- Takeover of the patient on the intensive care unit,
- Transport of the patient from the intensive care unit to the ambulance car
- Transport of the patient in the ambulance car
- The agreement of systolic, diastolic and mean CNAP and IBP blood pres-sure changes determined on a beat-to-beat basis during:
- Takeover of the patient on the intensive care unit,
- Transport of the patient from the intensive care unit to the ambulance car
- Transport of the patient in the ambulance car
The beat-to-beat readings of CNAP and IBP will be automatically recorded electronically on a memory card in the transport monitor. CNAP data will additionally be recorded directly on the CNAP Monitor with a memory stick. Safety will be assessed by clinical observations as well as adverse events (AE) recording.
Detailed description
Arterial pressure (AP) is one of the most important physiological variables. Particularly in emergency medicine, AP needs to be monitored repeatedly or even better, continuously. This is usually done using an oscillometric pressure device (NIBP). A number of studies emphasise the importance of continuous AP monitoring as more than 20% of all hypotensive episodes may be missed by NIBP and another 20% are detected with delay. Prolonged hypotension precedes 56% of perioperative cardiac arrests and is associated with a significant increase of the 1-year mortality rate, indicating that NBP monitoring especially in patients with cardiovascular diseases might be insufficient independent from the clinical setting. Recently, a monitor for continuous non-invasive AP monitoring (CNAP™ Monitor 500) was introduced. It was shown that during procedures with high risk of hypotension NIBP missed significant more hypotensive episodes than CNAP. At the moment we have no evidence of the performance of CNAP in the preclinical emergency medicine. The evaluation against the gold standard of invasive pressure measurement in this study will help us to evaluate the performance of CNAP in the preclinical setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Device: CNAP-MonitorEmergency Patients with applied arterial blood pressure measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU Patients with established arterial pressure measurement
Key inclusion criteria (8 listed)
- Patients willing and capable of giving informed consent or with legal agents willing of giving informed consent
- Patients undergoing a transport from the intensive care unit to another institution with the ambulance car
- Patients where the IBP cannula was already placed on the intensive care unit
- Patients where IBP cannula, and CNAP upper arm cuff can be placed on the same arm, and CNAP finger cuff can be placed on the contra-lateral arm
- Intact perfusion of both arm evidenced by a negative Allen's test
Key exclusion criteria (5 listed)
- Patients with history of neurological, neuromuscular seizure
- Patients where IBP cannula cannot be placed in the radial artery
- Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm)
- Patients with history of arrhythmias
- Edematous patients
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 |
|---|---|---|
| CNAP-MonitorAlso: CNAP, Continuous non-invasive arterial blood pressure recordingContinuous non-invasive arterial blood pressure recording | Device | Cohort |
Primary outcome
agreement with invasive blood pressure
Time frame: 1 year
beat-to-beat readings of CNAP and IBP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
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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.
University Hospital Schleswig-Holstein - Campus Kiel
Kiel, Germany
Robert Hanss, PD Dr. study chair
UKSH-Campus Kiel
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 Robert Hanss at 1 site in Germany.
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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Jun 2012. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
agreement with invasive blood pressure (time frame: 1 year). 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 25 Jun 2012.