Prevalence of Prone Positioning Use in ARDS Patients

NCT02842788 | Completed

• 1 other identifier: 69HCL16_0468
• Study Type: observational
• Target: 736
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

prone position; acute respiratory distress syndrome (ARDS); mechanical ventilation; ICU; prevalence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Prevalence of the use of the prone position in each ARDS category

  Day 1

• Occurence of reasons for not using prone position in ARDS patients

  Day 1

• PaO2

  Day 1

• PaO2/FIO2

  Day 1

• Duration of prone position session

  Day 1

Study Arms (1)

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

Interventions

Prone positioning PROCEDURE

Turning the patient face down for several consecutive hours

ARDS patients receiving invasive mechanical ventilation in ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ARDS under mechanical ventilation

You may qualify if:

• 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 PEEP ≥ 5 cmH2O
• Age ≥ 18 years
• Intubated or tracheotomized and mechanically ventilated

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Lyon, 69004, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Claude Guérin, Pr

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 25, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 12, 2018

Record last verified: 2018-03

Locations

FR (1)