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NCT02125331 · ClinicalTrials.gov registry record
Measurement of NonInvasive Blood Pressure in Neonates Through Adults and Special Populations
A clinical trial, sponsored by GE Healthcare.
- Terminated
- Registry status
- 83
- Enrollment target
NCT02125331 is a clinical trial that was terminated before completion, run by GE Healthcare. The registered enrollment target is 83 participants.
The verdict
NCT02125331 was terminated before completion, sponsored by GE Healthcare.
- TERMINATED
- Registry status
- 83 participants
- Enrollment target
Study Summary
This study is required to demonstrate that the non-invasive blood pressure (NIBP) measurement algorithms on two commercially available multifunction hemodynamic acquisition modules, the Patient Data Module (PDM) equipped with the DINAMAP® SUPERSTAT algorithm ("PDM-SUPERSTAT") and the Patient Side Module (PSM) equipped with Datex-Ohmeda GE algorithm ("PSM-Datex-Ohmeda"), provide accurate NIBP measurements in accordance with the guidelines provided by the most recent International Organization for Standardization (ISO) 81060-2:2013. Notably, the new ISO 81060-2:2013 supersedes the previous 2009 version of this standard, and this study is being conducted in accordance with the most recent applicable standards. This study will assess neonate, infant, children, pediatric, adolescent, and adult patients as well as adults with chronic atrial fibrillation in a population that requires non-emergent heart catheterization. This is a study conducted to satisfy both standards for two NIBP devices and, as such, does not require a statistical hypothesis.
Interventions
- PROCEDURE Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2014-04 |
| Est. Completion | 2019-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02125331
The ClinicalTrials.gov registry entry for NCT02125331 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GE Healthcare, which has 99 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM) is the first listed.
NCT02125331 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02125331 about?
NCT02125331 is a clinical study titled "Measurement of NonInvasive Blood Pressure in Neonates Through Adults and Special Populations". This study is required to demonstrate that the non-invasive blood pressure (NIBP) measurement algorithms on two commercially available multifunction hemodynamic acquisition modules, the Patient Data Module (PDM) equipped with the DINAMAP® SUPERSTAT algorithm ("PDM-SUPERSTAT") and the Patient Side Mo...
What is the current status of trial NCT02125331?
This trial is currently terminated. The enrollment target is 83 participants. The study started on 2014-04. Estimated completion is 2019-03.
What interventions are being tested in trial NCT02125331?
The interventions under investigation include: Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM) (PROCEDURE).
Who is sponsoring clinical trial NCT02125331?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
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