이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00029

2022년 9월 22일 업데이트: Masimo Corporation
ORi is a unitless index that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to PaO2 values of 100mmHg and below, and an ORi of 1.00 corresponds to PaO2 values of 200mmHg and above. In this study, the PaO2 is varied by controlling the concentration of oxygen the study volunteer breathes. Changes in ORi values are analyzed by comparing it to corresponding changes in PaO2 measurements from blood samples.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

29

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • California
      • Irvine, California, 미국, 92618
        • Masimo Corporation

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

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
  • Hemoglobin value is greater than or equal to 11 g/dL.
  • Baseline heart rate ≥ 45 bpm and ≤ 85 bpm.
  • Carbon monoxide (CO) value ≤ 2.0% fractional carboxyhemoglobin (FCOHb).
  • Subject has a physical status of ASA I or II (American Society of Anesthesiology Class 1; Healthy subjects without any systemic disease at all. American Society of Anesthesiology Class II; subjects with mild systemic disease) as it applies to the systemic disease portion of the classification.
  • Blood Pressure: (Systolic Blood Pressure ≤ 140 mmHg and ≥ 90 mmHg, Diastolic Blood Pressure ≤ 90 mmHg and ≥ 50 mmHg), and if blood pressure is lower than 100/60 subject passes an orthostatic blood pressure test
  • Subject is able to read and communicate in English and understands the study and risks involved.

Exclusion Criteria:

  • Subject is pregnant.
  • Subject has a BMI > 35 and has been classified as morbidly obese or at an increased risk for participation by a medical professional.
  • Subject has a history of fainting (vasovagal), blacking out or losing consciousness during or after a blood draw, or has a fear of blood draws.
  • Subject smokes one pack of cigarettes or more in one week, and/or the equivalent of e-cigarette liquid, and smokers are not being recruited as indicated in the CSRF.
  • Subject has open wounds, inflamed tattoos or piercings and/or any visible healing wounds that a medical professional renders them at an increased risk for participation (per physician discretion).
  • Subject has known drug or alcohol abuse or uses recreational drugs.
  • Subject experiences frequent or severe headaches and/or migraine headaches, migraine auras, altitude sickness, and/or headaches accompanied by visual changes or sensitivity to light or sound.
  • Subject has experienced a concussion or head injury with loss of consciousness within the past 12 months.
  • Subject has any history of a stroke, myocardial infarction, seizures or heart attack.
  • Subject who has taken anticoagulant medications within the last 30 days (excluding nonsteroidal anti-inflammatory drugs (NSAIDS).
  • Subject has donated blood within the past 4 weeks.
  • Subject has any chronic bleeding disorder (i.e. hemophilia)
  • Subject has any symptomatic cardiac dysrhythmia (i.e. atrial fibrillation) and has not received clearance from their physician to participate.
  • Subject has Wolff-Parkinson-White Syndrome or Stokes - Adams syndrome.
  • Subject has known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subjects' level of consciousness.
  • Subject has taken opioid pain medication within 24 hours of start of study.
  • Subject has any type of infectious disease (i.e. Hepatitis, HIV, Tuberculosis, Flu, Malaria, Measles, etc.).
  • Subject is taking medications known to treat any type of infectious disease (per physician discretion).
  • Subject has either signs or history of peripheral ischemia or carpal tunnel syndrome.
  • Subject has had invasive surgery within the past year- including but not limited to major dental surgery, appendix, plastic surgery (per physician discretion).
  • Subject has had invasive surgery within the past year- including but not limited to gallbladder, major fracture repairs (involving plates/ screws), jaw surgery, urinary tract surgery, major ENT surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery.
  • Subject has symptoms of congestion, head cold, flu or other illnesses.
  • Subject is claustrophobic and/or has generalized anxiety disorder.
  • Subject has been in severe car accident(s) or a similar type of accident(s) requiring hospitalization within the past 12 months.
  • Subject has any cancer or history of cancer (not including skin cancer), per physician discretion.
  • Subject has chronic unresolved asthma, lung disease (including COPD) and/or respiratory disease.
  • Subject is allergic to lidocaine, latex, adhesives, or plastic.
  • Subject has a heart condition, insulin-dependent Diabetes, or uncontrolled hypertension.
  • Subject has delivered vaginally, has had a pregnancy terminated, a miscarriage with hospitalization, or had a C-section within the past 6 months.
  • Subject intends to participate in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle, tennis) or exercise (working out, riding a bike, riding a skate board etc.), or any activity that will put additional stress on the wrist within 24 hours following a study that involved an arterial line.
  • Subject has any medical condition which in the judgement of the investigator and/or medical staff, renders them ineligible for participation in this study (Discretion of investigator/study staff).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: INVSENSOR00029
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor
Noninvasive pulse oximeter sensor

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
PaO2 값의 해당 변화와 비교하여 ORi 값의 변화에 ​​대한 민감도.
기간: 과목당 1~5시간
ORi는 단위가 없는 지표 값이며 ORi는 PaO2를 직접 측정하지 않습니다. 따라서 PaO2의 변화에 ​​대한 ORi의 변화를 평가하기 위해 민감도, 특이도 및 일치도를 계산합니다.
과목당 1~5시간
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values
기간: 1-5 hours per subject
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2.
1-5 hours per subject
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
기간: 1 to 5 hours per subject
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2.
1 to 5 hours per subject

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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)

2019년 8월 20일

기본 완료 (실제)

2019년 8월 28일

연구 완료 (실제)

2019년 8월 28일

연구 등록 날짜

최초 제출

2019년 9월 3일

QC 기준을 충족하는 최초 제출

2019년 9월 3일

처음 게시됨 (실제)

2019년 9월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 10월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 9월 22일

마지막으로 확인됨

2022년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • TP-20088

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. .

3
구독하다