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NCT Number: NCT02842788

Prevalence of Prone Positioning Use in ARDS Patients

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome (ARDS) Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Réanimation médicale, Hôpital de la Croix Rousse, CHU de Lyon, France

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prone positioning

Procedure

Turning the patient face down for several consecutive hours

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Prospective Study on the Prevalence on the Use of Prone Positioning in ARDS Patients

Acronym: APRONET

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 25, 2016
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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