- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06646991
서로 다른 산소 인터페이스를 갖는 여러 산소화 목표 비교 - 산소 유량에 미치는 영향 (Interfaces)
Oxygen therapy is at the heart of the healthcare system. Oxygen flow rates depend on a number of confounding factors confounding factors (target used, skin pigmentation, pulse oximeter used, etc.) The investigators have recently have recently demonstrated that the combination of these factors (different peripheral oxygen saturation (SpO2) targets and different oximeters) can have a significant impact on oxygen flows rates. The effect on oxygen flow was not simply additive .
The aim of this study is to evaluate the impact of the interface used on oxygen flow rates in different patient populations (main objective). The investigatoers also evaluate the impact of the interface on carbon dioxide (PaCO2), in particular with closed oxygen masks, with which rebreathing is theoretically possible (secondary objective).
secondary objective).
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: François Lellouche
- 전화번호: 1-418-656-8711
- 이메일: françoislellouche@criucpq.ulaval.ca
연구 장소
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Quebec
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Québec, Quebec, 캐나다, G1V4G5
- 모병
- Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
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연락하다:
- Francois Lellouche Principal Investigator
- 전화번호: 418-656-8711
- 이메일: francois.lellouche@criucpq.ulaval.ca
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adult (> or = 18 years old)
- Ongoing on conventional oxygen therapy with peripheral oxygen saturation (SpO2) between 88 and 100% with the usual oximeter
- SpO2 < 92% ambient air with the usual oximeter
Exclusion Criteria:
- No SpO2 signal with with the usual oximeter
- False nails or nail polish
- Severe anemia documented on last blood count during current hospitalization (haemoglobin (Hb) < 80g/L)
- Oxygen flow > 6 L/min
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Nellcor 산소 농도계
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Oxygen will be administered via nasal cannula up to 6 liters per minute during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the peripheral oxygen saturation (SpO2) target (92% for non chronic obstructive pulmonary disease (non COPD) patient and 90% for chronic obstructive pulmonary disease (COPD) patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used. Oxygen will be administered via nasal cannula up to 15 liters per minute during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used. Oxygen will be administered via an open during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used. Oxygen will be administered via simple oxygen face mask during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used. |
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다른: 노닌 산소농도측정기
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Oxygen will be administered via nasal cannula up to 6 liters per minute during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the peripheral oxygen saturation (SpO2) target (92% for non chronic obstructive pulmonary disease (non COPD) patient and 90% for chronic obstructive pulmonary disease (COPD) patient). The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Oxygen flow
기간: Mean Oxygen flow in the five last minute of each study period (between minute 10 and 15)
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Oxygen flows (or fraction of inspired oxygen (FiO2)) at the end of each study period (last minute average) to reach peripheral oxygen saturation (SpO2) target to reach SpO2 target with specific oxygen administration interfaces |
Mean Oxygen flow in the five last minute of each study period (between minute 10 and 15)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Partial oxygen weaning
기간: Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)
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Rate of partial oxygen weaning (Oxygen flow <=0.5 L/min) |
Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)
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Complete oxygen weaning
기간: Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)
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Rate of complete oxygen weaning (Oxygen flow =0 L/min or FiO2 0.21) |
Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gaps between the different oximeters
기간: through period completion, minute 15
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Average of the SpO2 value gaps between the different oximeters tested |
through period completion, minute 15
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Gaps between PaCO2
기간: through period completion, minute 15
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PaCO2 value at the end of the period |
through period completion, minute 15
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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