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CompletedNCT02722031Updated Sep 5, 2018

Severe Hypoxemia : Prevalence, Treatment and Outcome

An observational study in Critically Ill Patients Admitted in ICU, sponsored by French Society for Intensive Care. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by French Society for Intensive Care · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,694
Ages
18 Years and older
Sex
All
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Study summary

Hypoxemia is usually observed during ICU stay. Nevertheless, the prevalence of hypoxemia among patients admitted in ICU is not well known, in partly due to a lack of a consensual definition. Some of these patients meet the criteria of Acute Respiratory Distress Syndrome whom the definition has been recently modified in 2011. Many uncertainties are remaining in considering the patients with ARDS: prevalence of the category of "mild ARDS", the proportion of patients with invasive mechanical ventilation, the therapeutic modalities and the prognosis, in particular, the move towards a more severe ARDS category. Finally, many patients with hypoxemia do not meet ARDS definition. The prevalence of this population in ICU is unknown, likewise its prognosis. In this way, it would be interesting to compare, for each levels of hypoxemia (mild, moderate and severe) the prognosis of the patients with and without ARDS.

The main objective of the SPECTRUM study is to assess the prevalence of hypoxemia in French-speaking Intensive Care Unit in 2016 in using a single-day point-prevalence study design. Two periods of inclusion have been, actually, planned: from the 29th Mars to the 31st Mars and from the 5th to the 7th April. In each participating center, the day of the study will be chosen among these periods.

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Conditions studied

  • Critically Ill Patients Admitted in ICU

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Keywords

  • intensive care
  • prevalence
  • hypoxemia
  • ARDS
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In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's enrollment of 1,694 is above the median of 130 across 867 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

French Society for Intensive Care is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Critically ill patients admitted in Intensive Care

Inclusion criteria

  • Age 18 and older
  • Hospitalized in ICU during the 24 hours of the study
  • Information provided to the patient or proxy

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breast-feeding woman
  • Patient under guardianship or curators
  • Lack of social insurance
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,694 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Prevalence of hypoxemia defined by a ratio of the Partial Pressure of Oxygen in Arterial Blood (PaO2) / Fraction of inspired oxygen (FiO2) below 300 mm Hg

    prevalence of hypoxemia among patients hospitalized in ICU the day of the study

    Time frame: 1 day

Secondary outcomes

  1. Prevalence of severe hypoxemia defined by a ratio PaO2/ FiO2 below 100 mm Hg

    Time frame: 1 day

  2. Prevalence of mild hypoxemia defined by a ratio PaO2/FiO2 below 200 mm Hg and above 100 mm Hg

    Time frame: 1 day

  3. Prevalence of moderate hypoxemia defined by a ratio PaO2/FiO2 below 300 mm Hg and above 200 mm Hg

    Time frame: 1 day

  4. Prevalence of Acute Respiratory Distress Syndrome (ARDS) according the Berlin definition

    Time frame: 1 day

  5. ICU mortality

    Time frame: 90 days

  6. Prevalence of the different modalities of oxygen therapy

    Time frame: 1 day

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Study locations

1 site
  • CHRU Bretonneau
    Tours, 37044, France
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References and documents

Publications

  • Linko R, Okkonen M, Pettila V, Perttila J, Parviainen I, Ruokonen E, Tenhunen J, Ala-Kokko T, Varpula T; FINNALI-study group. Acute respiratory failure in intensive care units. FINNALI: a prospective cohort study. Intensive Care Med. 2009 Aug;35(8):1352-61. doi: 10.1007/s00134-009-1519-z. Epub 2009 Jun 13. PubMed 19526218 ↗
  • Brun-Buisson C, Minelli C, Bertolini G, Brazzi L, Pimentel J, Lewandowski K, Bion J, Romand JA, Villar J, Thorsteinsson A, Damas P, Armaganidis A, Lemaire F; ALIVE Study Group. Epidemiology and outcome of acute lung injury in European intensive care units. Results from the ALIVE study. Intensive Care Med. 2004 Jan;30(1):51-61. doi: 10.1007/s00134-003-2022-6. Epub 2003 Oct 16. PubMed 14569423 ↗
  • Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum In: JAMA. 2016 Jul 19;316(3):350. doi: 10.1001/jama.2016.6956. JAMA. 2016 Jul 19;316(3):350. doi: 10.1001/jama.2016.9558. PubMed 26903337 ↗
  • Rubenfeld GD, Caldwell E, Peabody E, Weaver J, Martin DP, Neff M, Stern EJ, Hudson LD. Incidence and outcomes of acute lung injury. N Engl J Med. 2005 Oct 20;353(16):1685-93. doi: 10.1056/NEJMoa050333. PubMed 16236739 ↗
  • ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669. PubMed 22797452 ↗
  • SRLF Trial Group. Hypoxemia in the ICU: prevalence, treatment, and outcome. Ann Intensive Care. 2018 Aug 13;8(1):82. doi: 10.1186/s13613-018-0424-4. Erratum In: Ann Intensive Care. 2019 Jan 21;9(1):10. doi: 10.1186/s13613-019-0486-y. PubMed 30105416 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02722031
Lead sponsor
French Society for Intensive Care
Responsible party
Sponsor
First posted
Mar 29, 2016
Start date
Mar 2016
Primary completion
Jun 2016
Completion
Aug 2017
Last update
Sep 5, 2018
View the source record on ClinicalTrials.gov ↗

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