Critically Ill Patients Admitted in ICU Clinical Trial
| NCT number | NCT02722031 |
| Other study ID # | SPECTRUM |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2016 |
| Est. completion date | August 2017 |
| Verified date | September 2018 |
| Source | French Society for Intensive Care |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1694 |
| Est. completion date | August 2017 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU Bretonneau | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| French Society for Intensive Care | Clinical Research Committee, French Society for Intensive Care, France |
France,
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. — View 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, — View Citation
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 — View Citation
Linko R, Okkonen M, Pettilä V, Perttilä 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):1352-6 — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 1 day | |
| Secondary | Prevalence of severe hypoxemia defined by a ratio PaO2/ FiO2 below 100 mm Hg | 1 day | ||
| Secondary | Prevalence of mild hypoxemia defined by a ratio PaO2/FiO2 below 200 mm Hg and above 100 mm Hg | 1 day | ||
| Secondary | Prevalence of moderate hypoxemia defined by a ratio PaO2/FiO2 below 300 mm Hg and above 200 mm Hg | 1 day | ||
| Secondary | Prevalence of Acute Respiratory Distress Syndrome (ARDS) according the Berlin definition | 1 day | ||
| Secondary | ICU mortality | 90 days | ||
| Secondary | Prevalence of the different modalities of oxygen therapy | 1 day |