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

NCT01627470 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2012-06-25

No results posted yet for this study

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.

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.

Conditions

  • Blood Pressure

Interventions

DEVICE

CNAP-Monitor

Continuous non-invasive arterial blood pressure recording

Sponsors & Collaborators

  • Robert Hanss

    lead OTHER

Principal Investigators

  • Robert Hanss, PD Dr. · UKSH-Campus Kiel

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01627470 on ClinicalTrials.gov