ARDS Clinical Trial
The purpose of this piece of research is to assess the effect of altitude on the clinical evolution of ARDS. For this purpose, patients who live and receive care at sea level are compared with those who live and receive care at high altitudes. For reasons of convenience, a cut-point of 1500 meters above sea level was chosen. In addition to this, it will be sought to assess whether adjusting the cut-points for the severity categories of ARDS improves the ability to predict some adverse events, by comparison with unadjusted cut-points. The results of this research will probably be disruptive, and will provide the first information yet about the effect of altitude on ARDS; they will therefore be of great interest for the international scientific community and for the direct care of patients. A high bibliometric impact is to be expected.
HYPOTHESIS
Physiological adaptations generated by living at high altitude modify the clinical evolution
of ARDS.
OBJECTIVE
To describe the main clinical and developmental characteristics of ARDS diagnosed at
altitudes greater than 1500 meters above sea level.
To compare the main clinical and developmental characteristics of ARDS diagnosed at altitudes
greater than 1500 meters above sea level with those of cases diagnosed at altitudes below
1500 meters above sea level.
METHODOLOGY
Main events:
Incidence of ARDS
Mortality of ARDS
Duration of mechanical ventilation and length of ICU stay of patients with ARDS Sequelae
found 1 year and 3 years after diagnosis of ARDS
Secondary events
Recognition of ARDS by clinician
Modes of mechanical ventilation
Use of adjuvant therapies
Design: observational, prospective, cohort, multicenter, international study
Recruitment period: July 18, 2.016 - August 18, 2.016
General Procedure
The general organization chart of the study implies the participation of 3 lead researchers,
at least 1 researcher/coordinator per country, and main researchers of each service.
For the selection of participating services, a general invitation will be sent to all South
American ICUs located at altitudes greater than 1500 meters above sea level, as well as a
representative group of ICUs located below 1500 meters above sea level.
The 2 cohorts (altitude and sea level) will be generated afterwards; the size of each cohort
will be determined by convenience.
For the selection of each participating service, the exploratory form (appendix 1) will be
sent beforehand, in order to gain knowledge of its characteristics and possibilities; if the
center meets the criteria, it will be enrolled and the rest of the documents (research
protocols, appendices 2 and 3) will be sent to it.
Once the participating services are defined, coordination videoconferences will be held
before initiation of the study; an e-mail address will be set up for general coordination.
All questions will be answered in less than 24 hours.
The data will be collected in an Excel spreadsheet that will be sent to the coordinator of
each country, and he will distribute it to the main researcher of each participating center.
The information will be afterwards submitted to the general coordinators via the reverse
pathway. All information will be sent by e-mail; in order to maintain confidentiality, the
spreadsheets will be encrypted. The opening codes will be known only by the researchers
responsible for each service, for each country, and by the lead researchers of the study. The
data will be included by the main researcher of each center, under supervision of the
coordinator of each country.
Day 1 will be the day of admission to ICU with an unadjusted Pa02/Fi02 less than 300,
regardless of the day the patient was admitted to hospital or to ICU.
The protocol implies the gathering of basic data (appendix 3), that will be further obtained
when the patients meets the criterion of Pa02/Fi02 less than 300. Gathering of data ends 28
days after day 1 (IT MAY NOT CORRESPOND TO DAY 28 AFTER ADMISSION TO ICU); afterwards, data
such as date of extubation, of discharge from ICU and from hospital, and condition upon
discharge from hospital will be gathered.
Clinical and analytic data will be gathered on admission, and afterwards at the same hour of
the morning, while the patient continues under invasive mechanical ventilation.
Diagnosis of ARDS is made by two procedures: (A) automatic, which will consist of
individually picking each variable pertaining to the definition, and afterwards, by way of a
computer algorithm, defining whether the patient complies with the Berlin definition; (B)
clinical, the attending physician will be asked daily, since the moment when PaO2/Fi02<300,
what the reason for hypoxemia is. Both diagnoses will be independent and double-blinded. The
ratio of concordance will be calculated afterwards.
Operational definitions:
ARDS: Berlin definition.
Days free of mechanical ventilation are the number of days in which no invasive mechanical
ventilation is required, from disconnection to day 28. If the patient dies, 0 days free of
mechanical ventilation will be considered.
Driving pressure s the plateau pressure minus PEEP.
Incidence is the number of patients diagnosed with ARDS divided by the number of patients who
required invasive mechanical ventilation over the study period.
Number of patients with ARDS per bed of the service is the number of patients diagnosed with
ARDS divided by the number of beds suitable for mechanical ventilation available over the
study period.
Long-term follow-up (1 and 3 years) will be carried out by the central coordination team via
e-mail or, occasionally, by telephone.
Finally, a single database will be generated, with which the final report will be done.
All patients with incomplete data will be excluded from the analysis.
Statistical analysis:
In order to fulfill objective 1, a descriptive epidemiological analysis of the primary and
secondary events gathered in patients diagnosed with ARDS according to the Berlin definition.
In order to fulfill objective 2, a comparison is made between the proportion of primary and
secondary events between the altitude cohort and the sea-level cohort. Categorical variables
are presented as number of cases and percentage, continuous variables are presented as median
and percentiles 25-75. Categorical variables are compared by the chi-2 continuous variables
are compared by Mann-Whitney or Kruskal-Wallis non-parametric tests.
In order to fulfill objective 3, ROC curves will be made for each event, taking into
consideration the unadjusted and altitude-adjusted Berlin definition as dependent variable.
The final data report will be done following the recommendations of the Strengthening the
Reporting of Observational Studies in Epidemiology (STROBE) statement guidelines for
observational cohort studies.
The whole statistical analysis will be made with the free R program
(http://www.R-project.org). All P values will be two-tail P values, considering a <0.05 level
of signification.
ACCESSIBILITY OF DATA
The data will be accessible to any researcher upon written request to the Latin American
Network of High-Altitude Intensive Care Medicine (RELAMI).
The request must be written in Spanish and include:
justification for using the data
commitment to using the data for exclusively scientific purposes (explicitly stating that
they will not be used for economic purposes)
commitment to publishing the data in a pubmed indexed journal within a one-year period
proof of experience and background in the field of clinical research adhesion to the code of
ethics
RELAMI will analyze the request and decide within a 60-day period from receipt of the
request. If the response is positive, the data will be sent anonymized; if it is negative,
the reasons will be explained.
ECONOMIC ASPECTS
This study does not have sponsors. No researcher will receive economic compensation or any
other type of reward for participating.
ETHICAL ASPECTS
This study will be carried out in accordance with the ethical principles established by the
International Conference on Harmonization, guidelines for Good Clinical Practice (GCP), which
stem from the Helsinki Declaration and applicable regulation norms.
This study is considered to be of insignificant low risk, since it is an observational,
non-interventional study, and the data are gathered without identification. Each
participating ICU will process the pertaining institutional approvals, including a
renunciation of ethical revision.
Recorded dispensation of each participant for gathering clinical data without identification
will be sought as part of routine clinical care.
DATA MANAGEMENT AND DISSEMINATION OF RESULTS
The lead researchers and the Coordination Center will act as guardians of the data. Reports
of progress and final reports will be presented opportunely in national and international
conferences, giving priority to presentation during annual conferences in Latin America.
The results of the study will be published in indexed scientific journals, preferably of the
first decile.
Only aggregated and disidentified data will be publicly presented.
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