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Severe Hypoxemia : Prevalence, Treatment and Outcome

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ClinicalTrials.gov Identifier: NCT02722031
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
French Society for 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.


Condition or disease
Critically Ill Patients Admitted in ICU

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Study Type : Observational
Actual Enrollment : 1694 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : March 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2017



Primary Outcome Measures :
  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 [ Time Frame: 1 day ]
    prevalence of hypoxemia among patients hospitalized in ICU the day of the study


Secondary Outcome Measures :
  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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients admitted in Intensive Care
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722031


Locations
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France
CHRU Bretonneau
Tours, France, 37044
Sponsors and Collaborators
French Society for Intensive Care

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: French Society for Intensive Care
ClinicalTrials.gov Identifier: NCT02722031     History of Changes
Other Study ID Numbers: SPECTRUM
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Keywords provided by French Society for Intensive Care:
intensive care
prevalence
hypoxemia
ARDS

Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes