Safe Limits in Saturation (SLIM-study) (SLIM)
16. října 2018 aktualizováno: Angelique Spoelstra-de Man, Amsterdam UMC, location VUmc
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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Aktuální)
879
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Noord-Holland
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Amsterdam, Noord-Holland, Holandsko, 1007 MB
- VUMedicalCentre
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Ukázka pravděpodobnosti
Studijní populace
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.
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Relation SpO2-PaO2
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Factors influencing PaO2-Spo2 relation
Časové okno: Average of one week
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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
Časové okno: Average of one week
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To determine differences in the SpO2/PaO2 -relationship in different populations
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Average of one week
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Differences in relation in SpO2-PaO2 prospective versus retrospective
Časové okno: Average of one week
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To determine differences in the SpO2/PaO2 -relationship in a prospective and a retrospective cohort
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Average of one week
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: Angelique ME Spoelstra - de Man, Phd Md, Amsterdam UMC, location VUmc
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Baleeiro CE, Wilcoxen SE, Morris SB, Standiford TJ, Paine R 3rd. Sublethal hyperoxia impairs pulmonary innate immunity. J Immunol. 2003 Jul 15;171(2):955-63. doi: 10.4049/jimmunol.171.2.955.
- Kilgannon JH, Jones AE, Shapiro NI, Angelos MG, Milcarek B, Hunter K, Parrillo JE, Trzeciak S; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Association between arterial hyperoxia following resuscitation from cardiac arrest and in-hospital mortality. JAMA. 2010 Jun 2;303(21):2165-71. doi: 10.1001/jama.2010.707.
- Bellomo R, Bailey M, Eastwood GM, Nichol A, Pilcher D, Hart GK, Reade MC, Egi M, Cooper DJ; Study of Oxygen in Critical Care (SOCC) Group. Arterial hyperoxia and in-hospital mortality after resuscitation from cardiac arrest. Crit Care. 2011;15(2):R90. doi: 10.1186/cc10090. Epub 2011 Mar 8.
- Suzuki S, Eastwood GM, Glassford NJ, Peck L, Young H, Garcia-Alvarez M, Schneider AG, Bellomo R. Conservative oxygen therapy in mechanically ventilated patients: a pilot before-and-after trial. Crit Care Med. 2014 Jun;42(6):1414-22. doi: 10.1097/CCM.0000000000000219.
- Kuisma M, Boyd J, Voipio V, Alaspaa A, Roine RO, Rosenberg P. Comparison of 30 and the 100% inspired oxygen concentrations during early post-resuscitation period: a randomised controlled pilot study. Resuscitation. 2006 May;69(2):199-206. doi: 10.1016/j.resuscitation.2005.08.010. Epub 2006 Feb 24.
- O'Driscoll BR, Howard LS, Davison AG; British Thoracic Society. BTS guideline for emergency oxygen use in adult patients. Thorax. 2008 Oct;63 Suppl 6:vi1-68. doi: 10.1136/thx.2008.102947. No abstract available. Erratum In: Thorax. 2009 Jan;64(1):91.
- 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.
- de Jonge E, Peelen L, Keijzers PJ, Joore H, de Lange D, van der Voort PH, Bosman RJ, de Waal RA, Wesselink R, de Keizer NF. Association between administered oxygen, arterial partial oxygen pressure and mortality in mechanically ventilated intensive care unit patients. Crit Care. 2008;12(6):R156. doi: 10.1186/cc7150. Epub 2008 Dec 10.
- 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.
- Lodato RF. Decreased O2 consumption and cardiac output during normobaric hyperoxia in conscious dogs. J Appl Physiol (1985). 1989 Oct;67(4):1551-9. doi: 10.1152/jappl.1989.67.4.1551.
- Haque WA, Boehmer J, Clemson BS, Leuenberger UA, Silber DH, Sinoway LI. Hemodynamic effects of supplemental oxygen administration in congestive heart failure. J Am Coll Cardiol. 1996 Feb;27(2):353-7. doi: 10.1016/0735-1097(95)00474-2.
- Zwemer CF, Whitesall SE, D'Alecy LG. Cardiopulmonary-cerebral resuscitation with 100% oxygen exacerbates neurological dysfunction following nine minutes of normothermic cardiac arrest in dogs. Resuscitation. 1994 Mar;27(2):159-70. doi: 10.1016/0300-9572(94)90009-4. Erratum In: Resuscitation 1994 May;27(3):267.
- Decalmer S, O'Driscoll BR. Oxygen: friend or foe in peri-operative care? Anaesthesia. 2013 Jan;68(1):8-12. doi: 10.1111/anae.12088. Epub 2012 Nov 7. No abstract available.
- 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.
- Swain DP, Pittman RN. Oxygen exchange in the microcirculation of hamster retractor muscle. Am J Physiol. 1989 Jan;256(1 Pt 2):H247-55. doi: 10.1152/ajpheart.1989.256.1.H247.
- 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.
- Durlinger EMJ, Spoelstra-de Man AME, Smit B, de Grooth HJ, Girbes ARJ, Oudemans-van Straaten HM, Smulders YM. Hyperoxia: At what level of SpO2 is a patient safe? A study in mechanically ventilated ICU patients. J Crit Care. 2017 Jun;39:199-204. doi: 10.1016/j.jcrc.2017.02.031. Epub 2017 Mar 2.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. prosince 2015
Primární dokončení (Aktuální)
1. srpna 2017
Dokončení studie (Aktuální)
1. srpna 2017
Termíny zápisu do studia
První předloženo
30. listopadu 2015
První předloženo, které splnilo kritéria kontroly kvality
25. ledna 2016
První zveřejněno (Odhad)
28. ledna 2016
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
18. října 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
16. října 2018
Naposledy ověřeno
1. října 2018
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2014.524 (A2015.361)
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