- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02666937
Safe Limits in Saturation (SLIM-study) (SLIM)
A study consisting of a prospective and retrospective cohort in the ICU, ER and pulmonary department in a university hospital in Amsterdam and a teaching hospital in Alkmaar, the Netherlands.
The relationship between the oxygen saturation measured by pulse-oximetry and the arterial PaO2 is investigated in order to investigate which transcutaneous saturation values are safe when administering oxygen in relation to hyperopia and hypoxia.
연구 개요
상세 설명
This study consists of two parts a prospective and a retrospective part.
- Prospective part: Patients in the ICU, the emergency room and the pulmonary function department of the VU university medical centre will be included. Arterial blood gas analysis is a tool often used to determine PaO2 in regular care. When an arterial blood gas analysis is performed for regular patient care, the corresponding SpO2 is measured. Information such as blood pressure, heart rate, amount of administered fluids and shock-related-parameters are obtained from the patient files. For the ICU patients capillary refill, acra temperature and the mottling scores are examined. The peripheral flow index and temperature index is measured. When more arterial blood gas samples are drawn over time in one patient, multiple datasets can be included per patient, as long as the samples are drawn two hours apart.
- Retrospective part: Patients with a (suspected) pulmonary disease who underwent pulmonary function tests with arterial bloodgas sampling in the VU medical center and Medical Centre Alkmaar in the last 25 years. The PaO2 and corresponding SpO2 will be obtained from the test and parameters such as blood pressure, heart rate and administered oxygen will be retrieved from the databases with these test results.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Noord-Holland
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Amsterdam, Noord-Holland, 네덜란드, 1007 MB
- VUMedicalCentre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Prospective
- ICU - VUmc: Critically ill patients, requiring invasive monitoring
- Pulmonary function department - VUmc: Patients requiring a pulmonary function test with arterial bloodgas analysis.
- ER VUmc: Patients presented at the shockroom or patients in the general ER, requiring arterial bloodgas analysis.
Retrospective
- Pulmonary function departments: Patients who underwent a pulmonary function test with arterial bloodgas analysis in the last 25 years.
설명
Inclusion criteria for all inclusions:
- Age: 18>
- Requiring arterial bloodgas analysis
Exclusion criteria for all inclusions:
- Hyperbilirubinemia (>20 μmol/L)
- CO-Hb (>1,5%)
- MetHb (>1,5%)
- Unreliable pulsatile SpO2 curve
Additional inclusion criteria:
- Prospective, ICU - VUmc: On mechanical ventilation. Arterial line in place.
Additional exclusion criteria:
- Prospective, ICU - VUmc: On extracorporeal membrane oxygenation. Therapeutic hypothermia.
- Retrospective, Pulmonary function departments: Uncertainty whether SpO2 was measured exactly during arterial bloodgas sampling.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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ICU-patients (prospective)
Critically ill patients (18 years and older) on mechanically ventilation who have an arterial line and require bloodgasanalysis for medical reasons
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Emergency Department (prospective)
Patients (18 years and older), who are presented to the Emergency Department, and require bloodgasanalysis for medical reasons
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Pulmonary department (prospective)
Patients (18 years and older) who visit the outpatient clinic of the pulmonary department for different pulmonary functional test and require bloodgasanalysis for medical reasons
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Pulmonary department (retrospective)
Patients (18 years and older) who visited the outpatient clinic of the pulmonary department in the past of the VU medical centre in Amsterdam or the Medical Centre Alkmaar for different pulmonary functional test and required bloodgasanalysis for medical reasons
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Relation SpO2-PaO2
기간: Average of one week
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To determine peripherally measured saturation targets between which no hyperoxia and hypoxia will occur
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Average of one week
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Factors influencing PaO2-Spo2 relation
기간: Average of one week
|
To identify factors influencing the relationship between SpO2 and PaO2, such as hemodynamics, peripheral circulation, shock and pH
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Average of one week
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Relation in SpO2-PaO2 in different populations
기간: Average of one week
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To determine differences in the SpO2/PaO2 -relationship in different populations
|
Average of one week
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Differences in relation in SpO2-PaO2 prospective versus retrospective
기간: Average of one week
|
To determine differences in the SpO2/PaO2 -relationship in a prospective and a retrospective cohort
|
Average of one week
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Angelique ME Spoelstra - de Man, Phd Md, Amsterdam UMC, location VUmc
간행물 및 유용한 링크
일반 간행물
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- Nitzan M, Romem A, Koppel R. Pulse oximetry: fundamentals and technology update. Med Devices (Auckl). 2014 Jul 8;7:231-9. doi: 10.2147/MDER.S47319. eCollection 2014.
- Rincon F, Kang J, Maltenfort M, Vibbert M, Urtecho J, Athar MK, Jallo J, Pineda CC, Tzeng D, McBride W, Bell R. Association between hyperoxia and mortality after stroke: a multicenter cohort study. Crit Care Med. 2014 Feb;42(2):387-96. doi: 10.1097/CCM.0b013e3182a27732.
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- Austin MA, Wills KE, Blizzard L, Walters EH, Wood-Baker R. Effect of high flow oxygen on mortality in chronic obstructive pulmonary disease patients in prehospital setting: randomised controlled trial. BMJ. 2010 Oct 18;341:c5462. doi: 10.1136/bmj.c5462.
- Jensen LA, Onyskiw JE, Prasad NG. Meta-analysis of arterial oxygen saturation monitoring by pulse oximetry in adults. Heart Lung. 1998 Nov-Dec;27(6):387-408. doi: 10.1016/s0147-9563(98)90086-3.
- Davis WB, Rennard SI, Bitterman PB, Crystal RG. Pulmonary oxygen toxicity. Early reversible changes in human alveolar structures induced by hyperoxia. N Engl J Med. 1983 Oct 13;309(15):878-83. doi: 10.1056/NEJM198310133091502.
- Cornet AD, Kooter AJ, Peters MJ, Smulders YM. Supplemental oxygen therapy in medical emergencies: more harm than benefit? Arch Intern Med. 2012 Feb 13;172(3):289-90. doi: 10.1001/archinternmed.2011.624. Epub 2012 Jan 9. No abstract available.
- Meyhoff CS, Jorgensen LN, Wetterslev J, Christensen KB, Rasmussen LS; PROXI Trial Group. Increased long-term mortality after a high perioperative inspiratory oxygen fraction during abdominal surgery: follow-up of a randomized clinical trial. Anesth Analg. 2012 Oct;115(4):849-54. doi: 10.1213/ANE.0b013e3182652a51. Epub 2012 Jul 13.
- Quintard H, Patet C, Suys T, Marques-Vidal P, Oddo M. Normobaric hyperoxia is associated with increased cerebral excitotoxicity after severe traumatic brain injury. Neurocrit Care. 2015 Apr;22(2):243-50. doi: 10.1007/s12028-014-0062-0.
- Jackson RM. Pulmonary oxygen toxicity. Chest. 1985 Dec;88(6):900-5. doi: 10.1378/chest.88.6.900.
- Fracica PJ, Knapp MJ, Piantadosi CA, Takeda K, Fulkerson WJ, Coleman RE, Wolfe WG, Crapo JD. Responses of baboons to prolonged hyperoxia: physiology and qualitative pathology. J Appl Physiol (1985). 1991 Dec;71(6):2352-62. doi: 10.1152/jappl.1991.71.6.2352.
- Harten JM, Anderson KJ, Angerson WJ, Booth MG, Kinsella J. The effect of normobaric hyperoxia on cardiac index in healthy awake volunteers. Anaesthesia. 2003 Sep;58(9):885-8. doi: 10.1046/j.1365-2044.2003.03333.x.
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- Sinex JE. Pulse oximetry: principles and limitations. Am J Emerg Med. 1999 Jan;17(1):59-67. doi: 10.1016/s0735-6757(99)90019-0.
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- Astiz ME, Rackow EC, Kaufman B, Falk JL, Weil MH. Relationship of oxygen delivery and mixed venous oxygenation to lactic acidosis in patients with sepsis and acute myocardial infarction. Crit Care Med. 1988 Jul;16(7):655-8. doi: 10.1097/00003246-198807000-00001.
- van Genderen ME, Lima A, Bakker J, van Bommel J. [Peripheral circulation in critically ill patients: non-invasive methods for the assessment of the peripheral perfusion]. Ned Tijdschr Geneeskd. 2013;157(9):A5338. Dutch.
- House JR, Tipton MJ. Using skin temperature gradients or skin heat flux measurements to determine thresholds of vasoconstriction and vasodilatation. Eur J Appl Physiol. 2002 Nov;88(1-2):141-5. doi: 10.1007/s00421-002-0692-3. Epub 2002 Sep 3.
- Sessler DI. Skin-temperature gradients are a validated measure of fingertip perfusion. Eur J Appl Physiol. 2003 May;89(3-4):401-2; author reply 403-4. doi: 10.1007/s00421-003-0812-8. Epub 2003 Mar 25. No abstract available.
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유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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