Comparison of Continuous Non-invasive Pressure Device Versus Invasive Pressure Measurement During Prehospital Emergency

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Schleswig-Holstein.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Robert Hanss, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01627470
First received: November 2, 2011
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Blood Pressure
Device: CNAP-Monitor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Continuous Non-invasive Arterial Pressure Device in Comparison With Invasive Pressure Measurement During Out-of-hospital Emergency

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • agreement with invasive blood pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    beat-to-beat readings of CNAP and IBP


Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort
Emergency Patients with applied arterial blood pressure measurement
Device: CNAP-Monitor
Continuous non-invasive arterial blood pressure recording
Other Names:
  • CNAP
  • Continuous non-invasive arterial blood pressure 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ICU Patients with established arterial pressure measurement

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627470

Locations
Germany
University Hospital Schleswig-Holstein - Campus Kiel Recruiting
Kiel, Germany, 24105
Contact: Florian Reifferscheid, Dr. med.    +49 431 597 2991    reifferscheid@uksh.de   
Sponsors and Collaborators
Robert Hanss
Investigators
Study Chair: Robert Hanss, PD Dr. UKSH-Campus Kiel
  More Information

No publications provided

Responsible Party: Robert Hanss, PD Dr. med., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01627470     History of Changes
Other Study ID Numbers: CNAP-ITW
Study First Received: November 2, 2011
Last Updated: June 22, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:
non-invasive arterial pressure
emergency
intensive care

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014