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Prevalence of Prone Positioning Use in ARDS Patients (APRONET)

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ClinicalTrials.gov Identifier: NCT02842788
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Prone positioning has been shown to improve survival in patients with acute respiratory distress syndrome (ARDS). However, a recent large observational study found that prone positioning was used in only 7% of all ARDS patients, and 16% in the severe category. However, this study did not focus on the prone position per se. In present study, the investigators would like to explore the rate of use of prone positioning in ARDS patients and the reasons why this treatment was not applied. The present study is one-day prevalence study repeated four times over one year.

The hypothesis is that the rate of use of prone position is greater than 50% in the severe ARDS category.


Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome (ARDS) Procedure: Prone positioning

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Study Type : Observational
Actual Enrollment : 736 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study on the Prevalence on the Use of Prone Positioning in ARDS Patients
Study Start Date : April 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017


Group/Cohort Intervention/treatment
ARDS patients receiving invasive mechanical ventilation in ICU
  1. ARDS criteria (Berlin definition) fulfilled the day of the study, whatever the ARDS stage. The onset of ARDS could have been established at any time between ICU admission and study day but ARDS criteria must be still present the day of the study. The ARDS criteria are listed below

    • Within 1 week of a known clinical insult or new or worsening respiratory symptoms
    • Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or nodules
    • Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (eg, echocardiography) to exclude hydrostatic edema if no risk factor present
  2. PaO2/FIO2 ≤ 300 with Positive end-expiratory pressure (PEEP) ≥ 5 cmH2O
  3. Age ≥ 18 years
  4. Intubated or tracheotomized and mechanically ventilated
Procedure: Prone positioning
Turning the patient face down for several consecutive hours




Primary Outcome Measures :
  1. Prevalence of the use of the prone position in ARDS [ Time Frame: Day 1 ]
    Number of patients with ARDS receiving prone position divided by number of patients with ARDS on the day of the study


Secondary Outcome Measures :
  1. Prevalence of the use of the prone position in each ARDS category [ Time Frame: Day 1 ]
    Number of patients with ARDS in each category receiving prone position divided by number of patients with ARDS in each category on the day of the study

  2. Occurence of reasons for not using prone position in ARDS patients [ Time Frame: Day 1 ]
    Reasons: No severe hypoxemia for the clinician, Intracranial hypertension, Mean arterial pressure < 65 mmHg, Unstable fractures, Pneumothorax with previous single drain, External cardiac stimulation or internal pacemaker inserted for less than 48 hours, Tracheotomy for less than 15 days (not for access to airways for the current mechanical ventilation purpose), Severe facial trauma or facial surgery in the last 15 days, Sternotomy in the last 15 days, Venous thrombosis treated by anticoagulant molecule for less than 48 hours, Massive hemoptysis requiring interventional radiology or other emergency procedure, Pregnant woman, Excess in workload, Other reason

  3. PaO2 [ Time Frame: Day 1 ]
    oxygenation (PaO2) to assess the physiological response to the prone position session

  4. PaO2/FIO2 [ Time Frame: Day 1 ]
    oxygenation (PaO2/FIO2) to assess the physiological response to the prone position session

  5. Duration of prone position session [ Time Frame: Day 1 ]
    Difference between time of onset to time of end (consecutive hours)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ARDS under mechanical ventilation
Criteria

Inclusion Criteria:

  • 1.ARDS criteria (Berlin definition) fulfilled the day of the study, whatever the ARDS stage. The onset of ARDS could have been established at any time between ICU admission and study day but ARDS criteria must be still present the day of the study. The ARDS criteria are listed below

    • Within 1 week of a known clinical insult or new or worsening respiratory symptoms
    • Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or nodules
    • Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (eg, echocardiography) to exclude hydrostatic edema if no risk factor present
  • 2.PaO2/FIO2 ≤ 300 with PEEP ≥ 5 cmH2O
  • 3.Age ≥ 18 years
  • 4.Intubated or tracheotomized and mechanically ventilated

Exclusion Criteria:

  • Patient non intubated the day of the study
  • No criteria for ARDS the day of the study even if these criteria were present between ICU admission and day of the study

Information from the National Library of Medicine

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): NCT02842788


Locations
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France
Réanimation médicale, Hôpital de la Croix Rousse, CHU de Lyon, France
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Claude Guérin, Pr Réanimation médicale, Hôpital de la Croix Rousse, CHU de Lyon, France
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02842788    
Other Study ID Numbers: 69HCL16_0468
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Keywords provided by Hospices Civils de Lyon:
prone position
acute respiratory distress syndrome (ARDS)
mechanical ventilation
ICU
prevalence
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury