Prevalence of Prone Positioning Use in ARDS Patients (APRONET)

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

Study Description

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

Study Design

• 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

Groups and Cohorts

Group/Cohort

Intervention/treatment

ARDS patients receiving invasive mechanical ventilation in ICU; 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; PaO2/FIO2 ≤ 300 with Positive end-expiratory pressure (PEEP) ≥ 5 cmH2O; Age ≥ 18 years; Intubated or tracheotomized and mechanically ventilated

Procedure: Prone positioning; Turning the patient face down for several consecutive hours

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Locations

France

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

Lyon, France, 69004

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

• Principal Investigator: Claude Guérin, Pr; Réanimation médicale, Hôpital de la Croix Rousse, CHU de Lyon, France

More Information

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT02842788
• Other Study ID Numbers: 69HCL16_0468
• First Posted: July 25, 2016
• 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:

Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury