AzTrials
AzTrials

HyperoxiaOxSIZgenNCT04291911

Retrospective Multicentre Observational Study on the Incidence of Hyperoxia in Non-intubated Patients in Intensive Care in Belgium Study OxSIZgen

An observational study of Hyperoxia, run by SIZ Nursing at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Oxygen is the most widely prescribed therapy in the ICU (intensive care unit) and can save lives in critical patients. While the deleterious effects of hypoxia are apparent and must be actively avoided, hyperoxia also has adverse effects. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperoxia
How many people
300 participants
Where
1 siteBelgium
Study dates
21 Sep 2020to 25 Sep 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Oxygen patients in intensive care hospitals and no-intubated

Who may be able to join

  • Patient having oxygen
  • Not to be ventilated
  • Being over 18 years old

Who cannot join

  • Sickle cell disease patient
  • 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
Show all 9Show fewer
  • Patients on ECMO
  • Patients with paracoate poisoning...
  • Patients included in other interventional studies

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Bruyneel Arnaud

    La Louvière

Other trials in Belgium

About this study

Official title: Prospective Multicentre Observational Study on the Incidence of Hyperoxia in Non-intubated Patients in Intensive Care in Belgium Study OxSIZgen

Oxygen is the most widely prescribed therapy in the ICU (intensive care unit) and can save lives in critical patients. While the deleterious effects of hypoxia are apparent and must be actively avoided, hyperoxia also has adverse effects. These include systemic, coronary and cerebral vasoconstriction; decreased coronary blood flow; pulmonary atelectasis and increased free radicals. Despite these deleterious effects, hyperoxia is common and frequent in the ICU (from 22% to 74%).

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.

Read more

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.

Conditions
Hyperoxia
Medical subject headings
Hyperoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04291911
Study groupRoleWhat they receive
INTENSIVE CARE UNITSNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. INCIDENCE HYPEROXIA

    Measured: one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start21 Sep 2020
  3. Primary completion25 Sep 2020
  4. Study completion25 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04291911
Sponsor's protocol ID
SIZNursing
Acronym
OxSIZgen
Status last verified
Oct 2020
First submitted
27 Feb 2020
Last updated
8 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29553985

  • 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.

    PubMed 31599335

  • 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.

    PubMed 25634474

  • 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.

    PubMed 20878146

  • 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.

    PubMed 22613692

  • 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.

    PubMed 29726345

  • 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.

    PubMed 30077082

  • 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.

    PubMed 30808337

  • 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.

    PubMed 29888278

  • 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.

    PubMed 31613432

  • 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.

    PubMed 28507176

  • 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.

    PubMed 30355567

  • 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.

    PubMed 29233740

Questions about this trial

What is this clinical trial studying?

An observational study of Hyperoxia, run by SIZ Nursing at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

INCIDENCE HYPEROXIA (time frame: one week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04291911, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in