Impact of Arterial CO2 Tension on Management and Outcome in Patients With Acute Hypoxemic Respirator Failure and ARDS (CO2 LUNG SAFE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03415529|
Recruitment Status : Completed
First Posted : January 30, 2018
Last Update Posted : August 14, 2019
|Condition or disease|
|Acute Severe Respiratory Failure Acute Respiratory Distress Syndrome|
This study will address a number of specific concerns, including:
- the incidence of hypocapnia and hypercapnia;
- the factors (e.g. ventilatory mode) contributing to hypocapnia and hypercapnia;
- the impact of hypocapnia and hypercapnia on progression of ARDS, duration of ventilation, ICU stay, hospital stay and patient outcome;
- the impact of pH (respiratory versus metabolic cause) on outcome variables.
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.
|Study Type :||Observational|
|Actual Enrollment :||4500 participants|
|Official Title:||Incidence of Hypercapnia and Impact of Arterial CO2 Tension on Management and Outcome in Patients With Acute Respiratory Distress Syndrome (ARDS)|
|Actual Study Start Date :||March 1, 2018|
|Actual Primary Completion Date :||September 30, 2018|
|Actual Study Completion Date :||December 30, 2018|
4500 patients with ARDS
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 [ Time Frame: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first ]The incidence of hypercapnia [i.e. PaCO2 > 45 mmHg] when ARDS arises
- Severity [ Time Frame: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first ]The severity of hypercapnia [i.e. PaCO2 > 45 mmHg] when ARDS arises ARDS
- Hypercapnia [ Time Frame: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first ]Factors (e.g. ventilatory mode) contributing to hypercapnia in patients with ARDS
- Hypercapnia [ Time Frame: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first ]The impact of hypercapnia on outcome on the progression of ARDS
- pH ((potential of hydrogen) [ Time Frame: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first ]The impact of pH (respiratory versus metabolic cause) on outcome variables
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415529
|Guy Marie FRANCOIS|
|Principal Investigator:||John LAFFEY||National University of Ireland, Galway|
|Principal Investigator:||Giacomo BELLANI||University of Milano-Bicocca (Monza, Italy)|