Critically Ill Patients Admitted in ICUNCT02722031
Severe Hypoxemia : Prevalence, Treatment and Outcome
An observational study of Critically Ill Patients Admitted in ICU, run by French Society for Intensive Care at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patients Admitted in ICU
- How many people
- 1,694 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients admitted in Intensive Care
Who may be able to join
- Age 18 and older
- Hospitalized in ICU during the 24 hours of the study
- Information provided to the patient or proxy
Who cannot join
- Pregnant or breast-feeding woman
- Patient under guardianship or curators
- Lack of social insurance
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Critically Ill Patients Admitted in ICU
- Keywords
- intensive care, prevalence, hypoxemia, ARDS
- Medical subject headings
- Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (6)
Prevalence of severe hypoxemia defined by a ratio PaO2/ FiO2 below 100 mm Hg
Measured: 1 day
Prevalence of mild hypoxemia defined by a ratio PaO2/FiO2 below 200 mm Hg and above 100 mm Hg
Measured: 1 day
Prevalence of moderate hypoxemia defined by a ratio PaO2/FiO2 below 300 mm Hg and above 200 mm Hg
Measured: 1 day
Prevalence of Acute Respiratory Distress Syndrome (ARDS) according the Berlin definition
Measured: 1 day
ICU mortality
Measured: 90 days
Prevalence of the different modalities of oxygen therapy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Critically Ill Patients Admitted in ICUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,694 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Society for Intensive Care
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722031
- Sponsor's protocol ID
- SPECTRUM
- Status last verified
- Sep 2018
- First submitted
- 23 Mar 2016
- Last updated
- 5 Sep 2018
- Results posted
- No
Publications
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.
PubMed 19526218Brun-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. Results from the ALIVE study. Intensive Care Med. 2004 Jan;30(1):51-61. doi: 10.1007/s00134-003-2022-6. Epub 2003 Oct 16.
PubMed 14569423Bellani 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.
PubMed 26903337Rubenfeld 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.
PubMed 16236739ARDS 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.
PubMed 22797452SRLF 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.
PubMed 30105416
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Hypoxemia : Prevalence, Treatment and Outcome
- ClinicalTrials.gov ID
- NCT02722031
- Acronym / sponsor ID
- SPECTRUM
- Conditions
- Critically Ill Patients Admitted in ICU
- Keywords
- intensive care, prevalence, hypoxemia, ARDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,694 participants (actual)
- Lead sponsor
- French Society for Intensive CareUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted in Intensive Care
Key inclusion criteria (3 listed)
- Age 18 and older
- Hospitalized in ICU during the 24 hours of the study
- Information provided to the patient or proxy
Key exclusion criteria (3 listed)
- Pregnant or breast-feeding woman
- Patient under guardianship or curators
- Lack of social insurance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Prevalence of severe hypoxemia defined by a ratio PaO2/ FiO2 below 100 mm Hg
Time frame: 1 day
Prevalence of mild hypoxemia defined by a ratio PaO2/FiO2 below 200 mm Hg and above 100 mm Hg
Time frame: 1 day
Prevalence of moderate hypoxemia defined by a ratio PaO2/FiO2 below 300 mm Hg and above 200 mm Hg
Time frame: 1 day
Prevalence of Acute Respiratory Distress Syndrome (ARDS) according the Berlin definition
Time frame: 1 day
ICU mortality
Time frame: 90 days
Prevalence of the different modalities of oxygen therapy
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Results publication: PubMed 19526218Linko 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.
- Results publication: PubMed 14569423Brun-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. Results from the ALIVE study. Intensive Care Med. 2004 Jan;30(1):51-61. doi: 10.1007/s00134-003-2022-6. Epub 2003 Oct 16.
- Results publication: PubMed 26903337Bellani 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.
- Results publication: PubMed 16236739Rubenfeld 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.
- Results publication: PubMed 22797452ARDS 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.
- Derived from this study: PubMed 30105416SRLF 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.
Related trials for Critically Ill Patients Admitted in ICU
Not yet recruitingObservational study
Lactate/Albumin Ratio and Mortality in Respiratory Failure
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Admission, Triage, and Discharge Criteria for Oncological Patients in the Intensive Care Unit
Cancer, Critical Care, Cancer Critically Ill
RecruitingPhase 4
Evaluation of the Clinical Impact of Adjunctive L-carnitine Therapy in Critically Ill Hepatic Patients Admitted to Intensive Care Unit
Hepatic
Not yet recruitingObservational study
Simplified Acute Physiology Score 2 and Pressure Ulcer Prediction in ICU.
Pressure Ulcers
Not yet recruiting
PRotEin Provision in Critical IllneSs -2
Critical Illness, Intensive Care (ICU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill Patients Admitted in ICU, run by French Society for Intensive Care at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02722031, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.