Effect of Three Side Hole Infusion Catheter on CT Image Quality Compared to a Standard Infusion Catheter
3. Mai 2018 aktualisiert von: Joseph P Hasapes, The University of Texas Health Science Center, Houston
IV Contrast Administration: Effect of Three Side Hole Infusion Catheter on CT Image Quality, Infusion Pressure, and Infusion Rates, Compared to a Standard Infusion Catheter
The purpose of this research study is to compare two types of catheters used for infusing the contrast dye necessary for viewing internal organs during computed tomography (CT) scanning.
The standard catheter, which has one hole from which contrast dye enters veins, will be compared to the Becton Dickinson Nexiva Diffusics System catheter, which has three holes for diffusing dye into veins.
The purpose of this study is to determine which catheter type gives the best image.
Studienübersicht
Status
Abgeschlossen
Intervention / Behandlung
Detaillierte Beschreibung
This will be a prospective, randomized, controlled trial.
The catheter is already in use at our facilities.
After informed consent, patients will be randomly given the standard or new catheter in our practice.
Envelopes with the random assignment will be available to the individuals consenting patients.
Randomization generally ensures that study groups are similar on average.
As age, sex, and weight impact image quality, we will collect data on these factors in case randomization results in an imbalance.
This will allow for control of these factors in analysis of the data.
Data will be collected from CT abdomen pelvis examinations within a 6 month-1 year period in 2016 - 2017.
Our primary outcome is image quality, measured as tissue density and distribution of contrast within the liver, spleen, aorta and IVC.
Our secondary outcomes include Peak Contrast Infusion Pressure and Injection Flow Rate.
Possible adverse events for use of any type of catheter include contrast infiltration into the subcutaneous tissues which is a minor limited event.
All infiltrations will be recorded as part of the permanent medical record, documented in the chart, and the referring physician notified.
The patient will be assessed by a physician immediately and referred to the ED if necessary for further evaluation.
Current technology utilizes Power injector equipment which alerts the technologist to the pressure being achieved.
If the injection pressure exceeds 325 psi the Power injector automatically shuts off.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
61
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Texas
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Houston, Texas, Vereinigte Staaten, 77030
- The University of Texas Health Science Center at Houston
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Patients undergoing contrast enhanced CT abdomen pelvis examinations at Lyndon B. Johnson General Hospital in Texas
- Patients whose access point is the antecubital fossa
- Patients receiving 20 or 22 gauge catheters for their CT exam
- Patients scanned on two 64 slice CT scanners at the same hospital
Exclusion Criteria:
- patients whose access point is other than antecubital fossa
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Becton Dickinson Nexiva Diffusics System
Intervention with the new Becton Dickinson Nexiva Diffusics System will be evaluated to see if it will improve image quality compared to the standard catheter.
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Becton Dickinson Nexiva Diffusics System will be used to inject IV contrast and will be compared to a single hole catheter to see if it improves image quality in the main vessels in the abdomen and pelvis because of its novel design.
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Aktiver Komparator: Standard intravenous catheter
Standard catheter with one hole at the tip will be compared to novel 3 hole Becton Dickinson Nexiva Diffusics System to see which catheter provides the best image quality.
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Standard catheter with one hole at the tip will be compared to a novel 3 hole catheter to see which catheter provides the best image quality.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Image Quality as Assessed by Ratio of Tissue Density of Main Portal Vein (MPV) to the Aorta
Zeitfenster: at the time of CT scanning
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The ratio of tissue density measured in the main portal vein (MPV) to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality.
Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality.
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at the time of CT scanning
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Image Quality as Assessed by Ratio of Tissue Density of Spleen to the Aorta
Zeitfenster: at the time of CT scanning
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The ratio of tissue density measured in the spleen to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality.
Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality.
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at the time of CT scanning
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Image Quality as Assessed by Ratio of Tissue Density of Inferior Vena Cava (IVC) to the Aorta
Zeitfenster: at the time of CT scanning
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The ratio of tissue density measured in the inferior vena cava (IVC) to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality.
Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality.
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at the time of CT scanning
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Image Quality as Assessed by Rating Scale
Zeitfenster: at the time of CT scanning
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Radiologists blinded to catheter type will review images and rate them on a scale of 1 to 10. 10 indicates a better outcome.
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at the time of CT scanning
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Peak Contrast Infusion Pressure
Zeitfenster: at the time of CT scanning
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The peak contrast infusion pressure is recorded in the electronic health record (EHR) during every CT examination preformed at the hospitals taking part in this study.
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at the time of CT scanning
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Injection Flow Rate
Zeitfenster: at the time of CT scanning
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The injection flow rate is recorded in the electronic health record (EHR) during every CT examination preformed at the hospitals taking part in this study.
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at the time of CT scanning
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Joseph Hasapes, MD, The University of Texas Health Science Center, Houston
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Oktober 2016
Primärer Abschluss (Tatsächlich)
1. November 2016
Studienabschluss (Tatsächlich)
1. November 2016
Studienanmeldedaten
Zuerst eingereicht
20. Oktober 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. Oktober 2016
Zuerst gepostet (Schätzen)
24. Oktober 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
6. Juni 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. Mai 2018
Zuletzt verifiziert
1. Mai 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- HSC-MS15-0906
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