NCT03239730

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2014

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

August 1, 2017

Last Update Submit

August 3, 2017

Conditions

DyspneaRespiratory Failure

Keywords

dyspneapHblood gas analysisemergency departmentIntensive care unit

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 1 day (direct admission to ICU from ED)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study population was derived from a cohort of adult patients admitted to the ED with acute dyspnea

You may qualify if:

  • patients who presented with acute dyspnea in the ED
  • patients who had an ABG analysis as part of the ED standard management

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

DyspneaRespiratory InsufficiencyEmergencies

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Mustapha SEBBANE, MD, PhD

    Emergency Department, University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 4, 2017

Study Start

May 23, 2013

Primary Completion

May 30, 2014

Study Completion

May 30, 2014

Last Updated

August 4, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)