Retrospective Multicentre Observational Study on the Incidence of Hyperoxia in Non-intubated Patients in Intensive Care in Belgium Study OxSIZgen
NCT ID: NCT04291911
Last Updated: 2020-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2020-09-21
2020-09-25
Brief Summary
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A recent meta-analysis published in "The Lancet" with more than 16,000 patients demonstrated an association between liberal oxygen therapy and mortality in critical patients. Other meta-analyses confirm its results with high quality data according to the authors.
A randomized controlled trial published in "The New England Journal of Medicine" comparing liberal versus conservative oxygen therapy showed no difference in mechanical ventilation days and mortality (The ICU-ROX, 2019). However, the difference in PaO2 between the two groups was very small and the PaO2 in the liberal group did not exceed 100 mmHg. In any case, conservative oxygen therapy is safe for critical patients.
The recommendations therefore recommend an oxygen saturation between 94-97% in critical patients and 88-92% in patients with COPD (Chronic Obstructive Pulmonary Disease) .
However, to our knowledge, no study has described the incidence of hyperoxia in non-intubated patients in the intensive care unit.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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INTENSIVE CARE UNITS
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Not to be ventilated
* Being over 18 years old
Exclusion Criteria
* Patient with pneumo/hemothorax
* Pregnant women, prisoners, denial of informed consent
* Patients who are related to an investigator
* Patients undergoing hyperbaric chamber therapy
* Patients with CO
* Patients on ECMO
* Patients with paracoate poisoning...
* Patients included in other interventional studies
18 Years
ALL
No
Sponsors
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SIZ Nursing
OTHER
Responsible Party
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Arnaud Bruyneel
President of SIZ Nursing, RN, CCRN, PhDc
Locations
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Bruyneel Arnaud
La Louvière, , Belgium
Countries
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References
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Suzuki S, Mihara Y, Hikasa Y, Okahara S, Ishihara T, Shintani A, Morimatsu H, Sato A, Kusume S, Hidaka H, Yatsuzuka H, Okawa M, Takatori M, Saeki S, Samuta T, Tokioka H, Kurasako T, Maeda M, Takeuchi M, Hirasaki A, Kitaura M, Kajiki H, Kobayashi O, Katayama H, Nakatsuka H, Mizobuchi S, Sugimoto S, Yokoyama M, Kusudo K, Shiraishi K, Iwaki T, Komatsu T, Hirai Y, Sato T, Kimura M, Yasukawa T, Kimura M, Taniguchi M, Shimoda Y, Kobayashi Y, Tsukioki M, Manabe N, Ando E, Kosaka M, Tsukiji T, Tokura C, Asao Y, Sugiyama M, Seto K; Okayama Research Investigation Organizing Network (ORION) investigators. Current Ventilator and Oxygen Management during General Anesthesia: A Multicenter, Cross-sectional Observational Study. Anesthesiology. 2018 Jul;129(1):67-76. doi: 10.1097/ALN.0000000000002181.
Hedenstierna G, Meyhoff CS. Oxygen toxicity in major emergency surgery-anything new? Intensive Care Med. 2019 Dec;45(12):1802-1805. doi: 10.1007/s00134-019-05787-8. Epub 2019 Oct 10. No abstract available.
Asfar P, Singer M, Radermacher P. Understanding the benefits and harms of oxygen therapy. Intensive Care Med. 2015 Jun;41(6):1118-21. doi: 10.1007/s00134-015-3670-z. Epub 2015 Jan 30. No abstract available.
de Graaff AE, Dongelmans DA, Binnekade JM, de Jonge E. Clinicians' response to hyperoxia in ventilated patients in a Dutch ICU depends on the level of FiO2. Intensive Care Med. 2011 Jan;37(1):46-51. doi: 10.1007/s00134-010-2025-z. Epub 2010 Sep 28.
Rachmale S, Li G, Wilson G, Malinchoc M, Gajic O. Practice of excessive F(IO(2)) and effect on pulmonary outcomes in mechanically ventilated patients with acute lung injury. Respir Care. 2012 Nov;57(11):1887-93. doi: 10.4187/respcare.01696. Epub 2012 May 15.
Chu DK, Kim LH, Young PJ, Zamiri N, Almenawer SA, Jaeschke R, Szczeklik W, Schunemann HJ, Neary JD, Alhazzani W. Mortality and morbidity in acutely ill adults treated with liberal versus conservative oxygen therapy (IOTA): a systematic review and meta-analysis. Lancet. 2018 Apr 28;391(10131):1693-1705. doi: 10.1016/S0140-6736(18)30479-3. Epub 2018 Apr 26.
You J, Fan X, Bi X, Xian Y, Xie D, Fan M, Xu W, Zhang K. Association between arterial hyperoxia and mortality in critically ill patients: A systematic review and meta-analysis. J Crit Care. 2018 Oct;47:260-268. doi: 10.1016/j.jcrc.2018.07.014. Epub 2018 Jul 20.
Ni YN, Wang YM, Liang BM, Liang ZA. The effect of hyperoxia on mortality in critically ill patients: a systematic review and meta analysis. BMC Pulm Med. 2019 Feb 26;19(1):53. doi: 10.1186/s12890-019-0810-1.
Stolmeijer R, Bouma HR, Zijlstra JG, Drost-de Klerck AM, Ter Maaten JC, Ligtenberg JJM. A Systematic Review of the Effects of Hyperoxia in Acutely Ill Patients: Should We Aim for Less? Biomed Res Int. 2018 May 14;2018:7841295. doi: 10.1155/2018/7841295. eCollection 2018.
ICU-ROX Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group; Mackle D, Bellomo R, Bailey M, Beasley R, Deane A, Eastwood G, Finfer S, Freebairn R, King V, Linke N, Litton E, McArthur C, McGuinness S, Panwar R, Young P; ICU-ROX Investigators the Australian and New Zealand Intensive Care Society Clinical Trials Group. Conservative Oxygen Therapy during Mechanical Ventilation in the ICU. N Engl J Med. 2020 Mar 12;382(11):989-998. doi: 10.1056/NEJMoa1903297. Epub 2019 Oct 14.
O'Driscoll BR, Howard LS, Earis J, Mak V; British Thoracic Society Emergency Oxygen Guideline Group; BTS Emergency Oxygen Guideline Development Group. BTS guideline for oxygen use in adults in healthcare and emergency settings. Thorax. 2017 Jun;72(Suppl 1):ii1-ii90. doi: 10.1136/thoraxjnl-2016-209729. No abstract available.
Siemieniuk RAC, Chu DK, Kim LH, Guell-Rous MR, Alhazzani W, Soccal PM, Karanicolas PJ, Farhoumand PD, Siemieniuk JLK, Satia I, Irusen EM, Refaat MM, Mikita JS, Smith M, Cohen DN, Vandvik PO, Agoritsas T, Lytvyn L, Guyatt GH. Oxygen therapy for acutely ill medical patients: a clinical practice guideline. BMJ. 2018 Oct 24;363:k4169. doi: 10.1136/bmj.k4169. No abstract available.
Perkins GD, Olasveengen TM, Maconochie I, Soar J, Wyllie J, Greif R, Lockey A, Semeraro F, Van de Voorde P, Lott C, Monsieurs KG, Nolan JP; European Resuscitation Council. European Resuscitation Council Guidelines for Resuscitation: 2017 update. Resuscitation. 2018 Feb;123:43-50. doi: 10.1016/j.resuscitation.2017.12.007. Epub 2017 Dec 9. No abstract available.
Other Identifiers
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SIZNursing
Identifier Type: -
Identifier Source: org_study_id
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