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

NCT01627470 | Unknown

• 1 other identifier: CNAP-ITW
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

non-invasive arterial pressure; emergency; intensive care

Outcome Measures

Primary Outcomes (1)

• agreement with invasive blood pressure

  beat-to-beat readings of CNAP and IBP

  1 year

Study Arms (1)

Cohort

Emergency Patients with applied arterial blood pressure measurement

Device: CNAP-Monitor

Interventions

CNAP-Monitor DEVICE

Continuous non-invasive arterial blood pressure recording

Also known as: CNAP, Continuous non-invasive arterial blood pressure recording

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU Patients with established arterial pressure measurement

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Robert Hanss: lead

Study Sites (1)

University Hospital Schleswig-Holstein - Campus Kiel

Kiel, 24105, Germany

RECRUITING

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Hanss, PD Dr.

  UKSH-Campus Kiel

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: June 25, 2012
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 25, 2012

Record last verified: 2012-06

Locations

DE (1)