2개의 다른 산소 농도계를 사용한 2개의 산소화 대상 비교 - 산소 유량 및 산소화에 미치는 영향 (Oxygap pong)
The investigators recently evaluated 4 different oximeters among the most commonly used with arterial catheter in place and compared SpO2 with SaO2 obtained on arterial gas. Correlations between SaO2 and SpO2 were poor for all oximeters, as previously known, and SpO2-SaO2 bias were different between oximeters. Some oximeters (Masimo, Nellcor) had lower biases but they detected less well hypoxemia. Some oximeters underestimated SaO2 (Nonin) but detected very well hypoxemia, and some overestimated SaO2 (Philips). The investigators concluded that oximeters provide different informations to clinicians, and oxygenation targets should take into account for these differences.
The assumption is that the SpO2 target AND oximeter used will both have an impact on oxygen flows and that these effects will add up. With a high SpO2 target, oxygen flows will be significantly greater and with the Nonin oximeter, the required flows will be greater than with the Philips oximeter.
NB: the results obtained were in a population with light skin pigmentation (96% of the patients were Fitzpatrick 1-2, reflecting the local hospitalized population).
연구 개요
상태
상세 설명
The oximeters to be evaluated will be the Nonin (Plymouth, MN), and the Philips (Eindhoven, Netherlands). The sensors used will be digital reusable sensors for all oximeters. Because of the impact of the fingers used for SpO2 measurement, each oximeter will be randomly assigned a different finger to each patient (digit 2 and 3 on the hand opposite to the arterial catheter).
Two SpO2 targets will be assessed: 90% and 94%. A total of four 10-minute periods will be performed in randomized order: Nonin 90, Nonin 94, Philips 90, and Philips 94.
At the end of each 10-minute period, arterial gas will be collected through the arterial catheter.
The adjustment of the oxygen flow rates will be performed manually. The average oxygen flow of the last 2 minutes of the period will be considered.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Francois Lellouche
- 전화번호: 3572 418656-8711
- 이메일: francois.lellouche@criucpq.ulaval.ca
연구 연락처 백업
- 이름: Pierre Alexandre Bouchard
- 전화번호: 2712 418656-8711
- 이메일: pierre-alexandre.bouchard@criucpq.ulaval.ca
연구 장소
-
-
Quebec
-
Québec, Quebec, 캐나다, G1V4G5
- 모병
- Institut Universitaire de Cardiologie et de Pneumologie de Québec
-
연락하다:
- Francois Lellouche
- 이메일: francois.lellouche@criucpq.ulaval.ca
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- ≥ 18 years of age
- Patients admitted to postoperative cardiac surgery intensive care unit
- Presence of an arterial catheter Specific for the extubate patient
- Ongoing on conventional oxygen therapy at moderate flow (up to a maximum of 5L/min) with SpO2 between 88 and 100% with the usual oximeter and nasal cannula.
- SpO2 < 92% ambient air Specific for the intubate patient FiO2 <= 0.60 with SpO2 between 88 and 100% with usual oximeter SpO2 < 92% with FiO2 0.21
Exclusion Criteria:
- No SpO2 signal with oximeter in use
- False nails or nail polish
- Methemoglobinemia >0.015 on last available arterial gas
- Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-CoV-2 ...) Specific for the extubate patient
- Expected to use another respiratory support within one hour of inclusion (NIV or nasal high flow oxygen) Planned extubation within one hour of inclusion
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Nonin oximeter with a 90% SpO2 target
During this periods , oxygen will be administered in an manual titration with the FreeO2 device (fixed flow mode) to reach 90% of SpO2. |
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Nonin oximeter |
|
실험적: Philips oximeter with a 90% SpO2 target
During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 90% of SpO2. |
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Philips oximeter |
|
실험적: Nonin oximeter with a 94% SpO2 target
During this periods , oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode) to reach 94% of SpO2. |
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter |
|
실험적: Philips oximeter with a 94% SpO2 target
During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 94% of SpO2. |
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Oxygen flow (or FiO2)
기간: Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
Oxygen flows (or FiO2) at the end of each study period (last minute average) to reach SpO2 target to reach SpO2 target with specific oximeter |
Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Difference between SpO2 and SaO2
기간: assessed up to 10 minutes - at the same of the arterial blood gases punction
|
Difference (%) between SpO2 from each oximeter and SaO2 (% of SaO2 overestimation and underestimation for each oximeter) |
assessed up to 10 minutes - at the same of the arterial blood gases punction
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean difference on oxymeter
기간: assessed up to 10 minutes - at the same of the arterial blood gases punction
|
Mean (±SD) of the gaps between the different oximeters tested |
assessed up to 10 minutes - at the same of the arterial blood gases punction
|
|
Occult hypoxemia
기간: assessed up to 10 minutes - at the same of the arterial blood gases punction
|
Percentage of occult hypoxemia (SaO2<90% and SpO2>=90%) |
assessed up to 10 minutes - at the same of the arterial blood gases punction
|
|
Occult hyperoxemia
기간: assessed up to 10 minutes - at the same of the arterial blood gases punction
|
Perrcentage of occult hyperoxemia (SaO2>96% and SpO2<=96%) |
assessed up to 10 minutes - at the same of the arterial blood gases punction
|
|
Partial oxygen weaning
기간: Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
Rate of partial oxygen weaning (Oxygen flow <=0.5 L/min) |
Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
|
Complete oxygen weaning
기간: Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
Rate of complete oxygen weaning (Oxygen flow =0 L/min or FiO2 0.21) |
Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
|
Respiratory support escalation
기간: Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
Indication of initiation of respiratory support escalation (Oxygen flow >6 L/min or FiO2 > 0.60) |
Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
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
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. .