DyspneaNCT03239730
Arterial pH Selectively Predicts Intensive Care Unit Transfer From the Emergency Department in Obese Patients With Acute Dyspnea
An observational study of Dyspnea and Respiratory Failure, run by Association pour la Formation du Personnel à la Medecine d'Urgence at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Respiratory Failure
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2013to 30 May 2014
- 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: Study population was derived from a cohort of adult patients admitted to the ED with acute dyspnea
Who may be able to join
- patients who presented with acute dyspnea in the ED
- patients who had an ABG analysis as part of the ED standard management
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dyspnea, Respiratory Failure
- Keywords
- dyspnea, pH, blood gas analysis, emergency department, Intensive care unit
- Medical subject headings
- Dyspnea, Respiratory Insufficiency, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of admission to the ICU or in ED mortality before ICU admission
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
Measured: up to 1 day (direct admission to ICU from ED)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start23 May 2013
- Primary completion30 May 2014
- Study completion30 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour la Formation du Personnel à la Medecine d'Urgence
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Montpellier
- Responsible party
- Sponsor
- Investigators
- Mustapha SEBBANE, MD, PhD, Principal investigator, Emergency Department, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239730
- Sponsor's protocol ID
- pH acute dyspnea
- Status last verified
- Aug 2017
- First submitted
- 1 Aug 2017
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial pH Selectively Predicts ICU Transfer in Obese Patients With Acute Dyspnea Presenting to the Emergency Department: a Prospective Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT03239730
- Acronym / sponsor ID
- pH acute dyspnea
- Conditions
- Dyspnea, Respiratory Failure
- Keywords
- dyspnea, pH, blood gas analysis, emergency department, Intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Association pour la Formation du Personnel à la Medecine d'UrgenceUniversity, hospital or other
- Collaborators
- University Hospital, Montpellier
- Study start
- 23 May 2013 (actual)
- Primary completion
- 30 May 2014 (actual)
- Study completion
- 30 May 2014 (actual)
- First posted
- 4 Aug 2017 (actual)
- 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.
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.
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 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
- Study population was derived from a cohort of adult patients admitted to the ED with acute dyspnea
Key inclusion criteria (2 listed)
- patients who presented with acute dyspnea in the ED
- patients who had an ABG analysis as part of the ED standard management
Key exclusion criteria (2 listed)
- 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
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
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
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 4 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Mustapha SEBBANE, MD, PhD principal investigator
Emergency Department, University Hospital, Montpellier
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 Dyspnea and Respiratory Failure, run by Association pour la Formation du Personnel à la Medecine d'Urgence 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 2 inclusion and 2 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 4 Aug 2017. 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?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2017.