An observational study in Acute Severe Respiratory Failure and Acute Respiratory Distress Syndrome, sponsored by European Society of Intensive Care Medicine. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by European Society of Intensive Care Medicine · Observational
There appears to be considerable variability in the approach physicians use to manage arterial carbon dioxide tensions, in patients in the early phases [first 48 hours] of ARDS (Acute hypoxemic respiratory failure and). A number of specific concerns exist, particularly the use of greater than needed inspired oxygen concentrations (potentially in 40% patients), and the proportion of hypocapnic patients in our cohort.
This study will address a number of specific concerns, including:
LUNG SAFE was a prospective observational study. There was not patient intervention. The current analysis is a secondary analysis of this existing database.
Data will be abstracted form the database on all patients meeting the inclusion criteria for ARDS (during the first 2 days from AHRF onset) for the following variables: Patient's demographic characteristics (age, sex) and chronic comorbidities, Arterial PCO2, pH in first 48 hours, Data on P/F ratio over course of illness, Duration of ventilation, ICU stay, hospital survival in patients identified as being exposed to hypocapnia (pCO2 \< or = to 30mmHg) and hypercapnia (PCO2 > or = to 45mmHg); Main ventilatory variables: mode of ventilation, tidal volume, respiratory.
Descriptive statistics will include proportions for categorical and mean (standard deviation) or median (interquartile range) for continuous variables, according the data distribution. The amount of missing data in the LUNG SAFE database is low so no assumptions will be made for missing data.
In order to investigate the relationship between PaCO2 and management factors, the investigators will stratify study population according the presence or absence of hypercapnia and will evaluate differences in management factors, using appropriate statistical tests. In detail, proportions will be compared using chi-squared or Fisher exact tests and mean values were compared using T-test or Wilcoxon rank sum test, as appropriate. Shapiro-Wilks test will be used to assess normality in data distribution. Moreover, they will perform univariate and multivariable logistic regression models using hypercapnia as dependent variable. Stepwise regression approach with significance alpha levels of 0.05 (both for entry and retention) will be used to establish a set of independent predictors. Odds ratios (ORs) and 95% confidence intervals (CIs) will be reported as measure of association.
They will assess the association of hypercapnia with different outcomes (ARDS progression, duration of mechanical ventilation, ICU and hospital stay and mortality) using generalized linear regression models (Poisson or Logistic regression models, according outcome distribution) and adjusting the relationship with all possible confounders identified with stepwise approach. Results will be reported as ORs, incidence rate ratios and corresponding 95% CI.
Particular attention will be given to the relationship and interaction between pH and PaCO2.
Survival analysis (Kaplan-Meier approach) will be used to estimate the time of liberation from invasive mechanical ventilation, of ICU and hospital discharge, and of hospital mortality within 28 days of AHRF onset in patients with and without hypercapnia. Differences in survival time will be assess by Log-Rank test.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's enrollment of 4,500 is above the median of 100 across 475 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →European Society of Intensive Care Medicine is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Patients over 18 years of age who fulfilled clinical criteria for ARDS and Acute Hypoxaemic respiratory failure were recruited into the LUNG SAFE trial (NCT02010073) that was published in JAMA, 2016 Jul 19;316(3):347).
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Exclusion Criteria:
This is a secondary analysis of data from the LUNG SAFE database to determine the impact of alterations in arterial carbon dioxide tensions in patients with ARDS.
Incidence
The incidence of hypercapnia \[i.e. PaCO2 \> 45 mmHg\] when ARDS arises
Time frame: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first
Severity
The severity of hypercapnia \[i.e. PaCO2 \> 45 mmHg\] when ARDS arises ARDS
Time frame: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first
Hypercapnia
Factors (e.g. ventilatory mode) contributing to hypercapnia in patients with ARDS
Time frame: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first
Hypercapnia
The impact of hypercapnia on outcome on the progression of ARDS
Time frame: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first
pH ((potential of hydrogen)
The impact of pH (respiratory versus metabolic cause) on outcome variables
Time frame: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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European Society of Intensive Care Medicine