Severe Hypoxemia : Prevalence, Treatment and Outcome

Completed

• Conditions: Critically Ill Patients Admitted in ICU

• Registration Number: NCT02722031
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-03-28
• Study First Posted: 2016-03-29
• Primary Completion: 2016-06
• Study Completion: 2017-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1694

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	1 day	prevalence of hypoxemia among patients hospitalized in ICU the day of the study

Secondary Outcome Measures

Name	Time	Method
Prevalence of severe hypoxemia defined by a ratio PaO2/ FiO2 below 100 mm Hg	1 day
Prevalence of Acute Respiratory Distress Syndrome (ARDS) according the Berlin definition	1 day
Prevalence of mild hypoxemia defined by a ratio PaO2/FiO2 below 200 mm Hg and above 100 mm Hg	1 day
Prevalence of moderate hypoxemia defined by a ratio PaO2/FiO2 below 300 mm Hg and above 200 mm Hg	1 day
ICU mortality	90 days
Prevalence of the different modalities of oxygen therapy	1 day

Trial Locations

Locations (1)

CHRU Bretonneau; 🇫🇷 Tours, France