NCT00603486

Brief Summary

The accuracy and/or performance of the GE DINAMAP noninvasive blood pressure (NIBP) monitors may be improved with modifications in software and/or hardware monitoring techniques and/or accessories. When changes are being made to the GE Monitor, testing can be done to evaluate performance of the investigational devices during and/or after product development.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

July 23, 2008

Status Verified

July 1, 2008

Enrollment Period

6 months

First QC Date

January 7, 2008

Last Update Submit

July 22, 2008

Conditions

Non-Invasive Blood Pressure

Keywords

Non-invasive Blood Pressure (NIBP)GE DinamapSuperSTAT

Outcome Measures

Primary Outcomes (1)

  • Evaluation of one of the GE DINAMAP NIBP Monitor algorithms, SuperSTAT NIBP, in neonatal and/or infant subjects.

    1 year

Interventions

GE DINAMAP with SuperSTAT algorithm monitorDEVICE

Apply cuff on a limb, cuff is inflated and deflated, monitor will displays non-invasive blood pressure values (systolic, diastolic, MAP, and pulse rate)

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonates in the NICU and newborn areas and/or infants.

You may qualify if:

  • Signed informed consent
  • Ability to single or dual monitor NIBP, ECG, and/or SpO2, whether or not already being monitored for any or all of these parameters.

You may not qualify if:

  • Any subject deemed too unstable, at the clinician's discretion, to participate in the study
  • Any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery.
  • Any subject who cannot tolerate, in the opinion of the clinician, multiple blood pressure measurements
  • Known disease state or medical condition that A) compromises circulation to the extremity (ies), B) compromises musculo-skeletal integrity, or C) otherwise contraindicates use of a NIBP cuff and/or SpO2 sensor on an extremity or ECG patches on skin
  • Excessive movement or excitability causing false values or no determinations (SP10 accuracy study only)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GE Healthcare

Tampa, Florida, 33614, United States

Location

Study Officials

  • Laura Haubner, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 7, 2008

First Posted

January 29, 2008

Study Start

November 1, 2007

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

July 23, 2008

Record last verified: 2008-07

Locations

US(1)