- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03239730
Arterial pH Selectively Predicts Intensive Care Unit Transfer From the Emergency Department in Obese Patients With Acute Dyspnea
August 3, 2017 updated by: Association pour la Formation du Personnel à la Medecine d'Urgence
Arterial pH Selectively Predicts ICU Transfer in Obese Patients With Acute Dyspnea Presenting to the Emergency Department: a Prospective Comparative Cohort Study
This study evaluates the prognostic value of arterial blood gas analysis in a cohort of Emergency Department patients presenting with shortness of breath of any cause, comparing obese and non-obese patients.
Study Overview
Status
Completed
Conditions
Detailed Description
Factors associated with admission to intensive care unit (ICU) or ED mortality before transfer to the ICU are analyzed in obese (BMI ≥ 30kg.m-2) and non-obese patients subgroups.
Study Type
Observational
Enrollment (Actual)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Montpellier, France, 34295
- Montpellier University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Study population was derived from a cohort of adult patients admitted to the ED with acute dyspnea
Description
Inclusion Criteria:
- patients who presented with acute dyspnea in the ED
- patients who had an ABG analysis as part of the ED standard management
Exclusion Criteria:
- Patients with treatment limitation decisions made by the medical teams against ICU admission, including severe cognitive impairment or palliative care ,
- Patients with immediate transfer to ICU due to shock and hemodynamic instability at ED admission
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite of admission to the ICU or in ED mortality before ICU admission
Time Frame: up to 1 day (direct admission to ICU from ED)
|
Admission to the ICU following ED management will be at the discretion of the attending ICU physician, and in agreement with current guidelines for ICU admission, according to standard management
|
up to 1 day (direct admission to ICU from ED)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mustapha SEBBANE, MD, PhD, Emergency Department, University Hospital, Montpellier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 23, 2013
Primary Completion (Actual)
May 30, 2014
Study Completion (Actual)
May 30, 2014
Study Registration Dates
First Submitted
August 1, 2017
First Submitted That Met QC Criteria
August 3, 2017
First Posted (Actual)
August 4, 2017
Study Record Updates
Last Update Posted (Actual)
August 4, 2017
Last Update Submitted That Met QC Criteria
August 3, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- pH acute dyspnea
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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