Clinical trial NCT02722031: Severe Hypoxemia : Prevalence, Treatment and Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill Patients Admitted in ICU
Keywords: intensive care
prevalence
hypoxemia
ARDS
Lead sponsor: French Society for Intensive Care
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 1694
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients admitted in Intensive Care

Brief 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.


Eligibility criteria: 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:

* Pregnant or breast-feeding woman
* Patient under guardianship or curators
* Lack of social insurance

Primary outcomes:
measure: 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
timeFrame: 1 day
Secondary outcomes:
measure: Prevalence of severe hypoxemia defined by a ratio PaO2/ FiO2 below 100 mm Hg
timeFrame: 1 day
measure: Prevalence of mild hypoxemia defined by a ratio PaO2/FiO2 below 200 mm Hg and above 100 mm Hg
timeFrame: 1 day
measure: Prevalence of moderate hypoxemia defined by a ratio PaO2/FiO2 below 300 mm Hg and above 200 mm Hg
timeFrame: 1 day
measure: Prevalence of Acute Respiratory Distress Syndrome (ARDS) according the Berlin definition
timeFrame: 1 day
measure: ICU mortality
timeFrame: 90 days
measure: Prevalence of the different modalities of oxygen therapy
timeFrame: 1 day
Other outcomes:
Locations:
city: Tours
country: France
facility: CHRU Bretonneau
Study officials:
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.