- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02943226
Effect of Three Side Hole Infusion Catheter on CT Image Quality Compared to a Standard Infusion Catheter
2018년 5월 3일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
61
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- The University of Texas Health Science Center at Houston
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Image Quality as Assessed by Ratio of Tissue Density of Main Portal Vein (MPV) to the Aorta
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Peak Contrast Infusion Pressure
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Joseph Hasapes, MD, The University of Texas Health Science Center, Houston
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 10월 1일
기본 완료 (실제)
2016년 11월 1일
연구 완료 (실제)
2016년 11월 1일
연구 등록 날짜
최초 제출
2016년 10월 20일
QC 기준을 충족하는 최초 제출
2016년 10월 20일
처음 게시됨 (추정)
2016년 10월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 6월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 5월 3일
마지막으로 확인됨
2018년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HSC-MS15-0906
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .