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Completed

NCT Number: NCT02722031

Severe Hypoxemia : Prevalence, Treatment and Outcome

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Bretonneau

Tours, 37044, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: 1 day

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

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

Sponsors and collaborators

Lead sponsor

French Society for Intensive Care

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Mar 29, 2016
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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