Prevalence of Prone Positioning Use in ARDS Patients

Completed

• Conditions: Acute Respiratory Distress Syndrome (ARDS)
• Interventions: Procedure: Prone positioning

• Registration Number: NCT02842788
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-25
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-09
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 736

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ARDS patients receiving invasive mechanical ventilation in ICU	Prone positioning	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

Primary Outcome Measures

Name	Time	Method
Prevalence of the use of the prone position in ARDS	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

Name	Time	Method
PaO2/FIO2	Day 1	oxygenation (PaO2/FIO2) to assess the physiological response to the prone position session
Duration of prone position session	Day 1	Difference between time of onset to time of end (consecutive hours)
Prevalence of the use of the prone position in each ARDS category	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
Occurence of reasons for not using prone position in ARDS patients	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
PaO2	Day 1	oxygenation (PaO2) to assess the physiological response to the prone position session

Trial Locations

Locations (1)

Réanimation médicale, Hôpital de la Croix Rousse, CHU de Lyon, France; 🇫🇷 Lyon, France