Prevalence of Prone Positioning Use in ARDS Patients

Acute Respiratory Distress Syndrome (ARDS) Clinical Trial

— APRONET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842788
• Other study ID #: 69HCL16_0468
• Status: Completed
• Phase: N/A
• First received: July 18, 2016
• Last updated: March 9, 2018
• Start date: April 2016
• Est. completion date: January 2017

Study information

• Verified date: March 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 736
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome (ARDS)
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
France	Réanimation médicale, Hôpital de la Croix Rousse, CHU de Lyon, France	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of the use of the prone position in ARDS	Number of patients with ARDS receiving prone position divided by number of patients with ARDS on the day of the study	Day 1
Secondary	Prevalence of the use of the prone position in each ARDS category	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	Day 1
Secondary	Occurence of reasons for not using prone position in ARDS patients	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	Day 1
Secondary	PaO2	oxygenation (PaO2) to assess the physiological response to the prone position session	Day 1
Secondary	PaO2/FIO2	oxygenation (PaO2/FIO2) to assess the physiological response to the prone position session	Day 1
Secondary	Duration of prone position session	Difference between time of onset to time of end (consecutive hours)	Day 1