Effect of Three Side Hole Infusion Catheter on CT Image Quality Compared to a Standard Infusion Catheter
3 maggio 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
61
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Texas
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Houston, Texas, Stati Uniti, 77030
- The University of Texas Health Science Center at Houston
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Image Quality as Assessed by Ratio of Tissue Density of Main Portal Vein (MPV) to the Aorta
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Peak Contrast Infusion Pressure
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Joseph Hasapes, MD, The University of Texas Health Science Center, Houston
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 ottobre 2016
Completamento primario (Effettivo)
1 novembre 2016
Completamento dello studio (Effettivo)
1 novembre 2016
Date di iscrizione allo studio
Primo inviato
20 ottobre 2016
Primo inviato che soddisfa i criteri di controllo qualità
20 ottobre 2016
Primo Inserito (Stima)
24 ottobre 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
6 giugno 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 maggio 2018
Ultimo verificato
1 maggio 2018
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- HSC-MS15-0906
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .