Healthy Volunteer Study to Evaluate the Impact of Various Common Interventions on Venous Pressure Signal Captured by PIVA
2021년 3월 29일 업데이트: Baxter Healthcare Corporation
Healthy Volunteer Study to Evaluate the Impact of Various Common Interventions on Venous Pressure Signal Captured by Peripheral Intravenous Analysis (PIVA) Technology
Non-invasive sensors have been used in research in the United States (US) to aid in the assessment of a subject's heart rate (HR), respiratory rate (RR) and fluid volume status. This estimate and its trended value over time, when used along with clinical signs and symptoms and other subject test results, can aid in the process of reaching a diagnosis and formulating a therapeutic plan when abnormalities of volume status, or RR are suspected.
Non-invasive sensors like the Peripheral IntraVenous Analysis (PIVA) sensor under development by Baxter and the Deltran blood pressure (BP) transducer, capture waveforms created by physiological mechanisms such as blood flow and breathing. An algorithm is then applied to the captured waveform to give clinicians an idea of hemodynamic (volume) status, and RR.
In this study, the functional robustness (e.g., subjects sitting, elevated leg positions, etc.) of the PIVA algorithm/technology will be demonstrated by evaluating the impact of various common interventions on the venous pressure signal. All subjects will undergo 33 interventions expected to take approximately 4 - 6 hours.
연구 개요
연구 유형
중재적
등록 (실제)
26
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Florida
-
Miami, Florida, 미국, 33126
- Baxter Investigational Site
-
-
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 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Has reviewed, understood and signed an informed consent.
- Age between 18-55 years.
- Body mass index between 18.5-35 kg/m2 with a minimum weight of 45 kg.
- Willing and able to comply with study procedures and duration.
- Subjects wearing any type of nail polish and/or acrylic nails must be willing to remove them prior to admission.
Exclusion Criteria:
- Female subjects who are pregnant.
- Subjects who are currently participating in, or have within the past 30 days participated in, another interventional clinical study or have used an investigational device or drug within the past 30 days.
Subjects with known respiratory conditions including but not limited to:
- uncontrolled / severe asthma
- flu / influenza
- pneumonia / bronchitis
- shortness of breath / respiratory distress
- respiratory or lung surgery
- emphysema, chronic obstructive pulmonary disease, lung disease
- any other health condition that the Principal Investigator thinks can affect respiratory health
Subjects with self-reported heart or cardiovascular conditions including but not limited to:
- hypertension
- history of cardiovascular surgery
- chest pain (angina)
- heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
- previous heart attack
- blocked artery
- unexplained shortness of breath
- congestive heart failure
- history of stroke
- transient ischemic attack
- carotid artery disease
- myocardial ischemia
- myocardial infarction
- restrictive or constrictive cardiomyopathy
- congenital heart disease other than patent foramen ovale, repaired atrial or ventricular septal defect
- any type of cardiac valve disease
- history of cardiac arrhythmias
Self-reported health conditions as identified in the Health Assessment Form
- diabetes
- uncontrolled thyroid disease
- kidney disease / chronic renal impairment
- history of seizures (except childhood febrile seizures)
- epilepsy
- history of unexplained syncope
- history of migraine attacks in the last 3 months
- head injury within the last 2 months
- cancer / chemotherapy
- other known health condition should be considered upon disclosure in health assessment form
- history of substance abuse or addiction to alcohol and or drugs within the last 12 months
Subjects with self-reported bleeding disorders including but not limited to:
- hemophilia
- von Willebrand disease
- history of blood clots
- history of bleeding problems
- bruises easily with everyday activities
- Subjects taking prescription blood thinners (like aspirin, clopidogrel, dipyridamole, or ticlopidine).
- Subjects may be excluded at the discretion of the Investigator.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 장치 타당성
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: IV line with an attached Deltran BP transducer
After device setup, subjects will be guided through a series of manipulations of the IV set while waveforms, pulse rate (PR), respiratory rate (RR) are collected at the start and stop of each test.
At the end of the study, the PIVA algorithm will then be applied to the waveforms and calculated values will be compared with those from bedside monitors to understand the effect of common manipulations on the waveforms and determine most optimal conditions for capturing RR and PR through peripheral IV analysis.
|
An IV line with an attached Deltran BP transducer will be used together with LabChart software to record venous waveforms during various interventions.
These waveforms will be processed using the PIVA algorithm and the calculated values will be compared to those from Nellcor respiratory monitor, Capnograph and cardiac telemetry monitoring.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Signal Quality Index (SQI) Score by Supine, Sitting, Standing Body Positions
기간: End of interventions #15 (supine for 5 minutes), #17 (sitting for 5 minutes), and #19 (standing for 5 minutes)
|
Ranking of subject body positions (supine, sitting, standing) based upon their impact on the venous waveform signal, from best to worst, based on the PIVA algorithm-derived SQI.
Score on the scale include 0=no signal, 1=poor signal, 2=good signal.
The highest percentage of time with good signal quality will be the best ranked position, and the lowest percentage of time with good signal quality will be the worst ranked position.
|
End of interventions #15 (supine for 5 minutes), #17 (sitting for 5 minutes), and #19 (standing for 5 minutes)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Agreement between PIVA algorithm-derived RR and RR measured with Capnography at Baseline
기간: End of 10 minute baseline
|
The difference of the PIVA algorithm-derived outcomes to their comparators (Capnography) under different conditions will be summarized descriptively by n, mean, median, minimum, and maximum.
The 95% limit of agreement and a Bland Altman plot will also be done for these endpoints.
Capnography is the monitoring of the concentration or partial pressure of carbon dioxide in the respiratory gases.
|
End of 10 minute baseline
|
|
Agreement between PIVA algorithm-derived RR and RR measured with Nellcor bedside monitor at Baseline
기간: End of 10 minute baseline
|
The difference of the PIVA algorithm-derived outcomes to their comparators (Nellcor) under different conditions will be summarized descriptively by n, mean, median, minimum, and maximum.
The 95% limit of agreement and a Bland Altman plot will also be done for these endpoints.
|
End of 10 minute baseline
|
|
Agreement between PIVA algorithm-derived RR and RR measured with manual counting
기간: End of 10 minute baseline
|
The manual count value will be an average of the 2 minutes then the count is taken over.
The difference of the PIVA algorithm-derived outcomes to their comparators (manual) under different conditions will be summarized descriptively by n, mean, median, minimum, and maximum.
The 95% limit of agreement and a Bland Altman plot will also be done for these endpoints.
|
End of 10 minute baseline
|
|
Agreement between PIVA algorithm derived PR and PR measured with Nellcor bedside monitor at Baseline
기간: End of 10 minute baseline
|
The difference of the PIVA algorithm-derived outcomes to their comparators (Nellcor) under different conditions will be summarized descriptively by n, mean, median, minimum, and maximum.
The 95% limit of agreement and a Bland Altman plot will also be done for these endpoints.
|
End of 10 minute baseline
|
|
Change in PIVA algorithm derived volume index between supine and passive leg raising positions
기간: End of Interventions #15 (supine for 5 minutes) and #18 (passive leg raise for 5 minutes)
|
The change in PIVA algorithm-derived volume index for a change in positions will be summarized descriptively by n, mean, median, minimum, and maximum.
|
End of Interventions #15 (supine for 5 minutes) and #18 (passive leg raise for 5 minutes)
|
|
Change in PIVA algorithm derived volume index between supine and standing positions
기간: End of interventions #15 (supine for 5 minutes) and #19 (standing for 5 minutes)
|
The change in PIVA algorithm-derived volume index for a change in positions will be summarized descriptively by n, mean, median, minimum, and maximum.
|
End of interventions #15 (supine for 5 minutes) and #19 (standing for 5 minutes)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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)
2020년 2월 26일
기본 완료 (실제)
2020년 3월 21일
연구 완료 (실제)
2020년 3월 21일
연구 등록 날짜
최초 제출
2020년 3월 25일
QC 기준을 충족하는 최초 제출
2020년 3월 25일
처음 게시됨 (실제)
2020년 3월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 4월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 3월 29일
마지막으로 확인됨
2021년 3월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- BXU544319
- Pro00041143 (기타 식별자: Advarra)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
미국에서 제조되어 미국에서 수출되는 제품
아니
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. .