Acute Respiratory Distress Syndrome (ARDS)APRONETNCT02842788
Prevalence of Prone Positioning Use in ARDS Patients
An observational study of Acute Respiratory Distress Syndrome (ARDS), run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- Prone positioning
- Type of treatment
- Surgery or procedure
- How many people
- 736 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ARDS under mechanical ventilation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Réanimation médicale, Hôpital de la Croix Rousse, CHU de Lyon, France
Lyon, 69004
About this study
Official title: Prospective Study on the Prevalence on the Use of Prone Positioning 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.
- Being tested
- Prone positioning
- Keywords
- prone position, acute respiratory distress syndrome (ARDS), mechanical ventilation, ICU, prevalence
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positioningProcedure or surgery
Turning the patient face down for several consecutive hours
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Prone positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (5)
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
Measured: Day 1
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
Measured: Day 1
PaO2
oxygenation (PaO2) to assess the physiological response to the prone position session
Measured: Day 1
PaO2/FIO2
oxygenation (PaO2/FIO2) to assess the physiological response to the prone position session
Measured: Day 1
Duration of prone position session
Difference between time of onset to time of end (consecutive hours)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 736 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude Guérin, Pr, Principal investigator, Réanimation médicale, Hôpital de la Croix Rousse, CHU de Lyon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842788
- Sponsor's protocol ID
- 69HCL16_0468
- Acronym
- APRONET
- Status last verified
- Mar 2018
- First submitted
- 18 Jul 2016
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Prevalence on the Use of Prone Positioning in ARDS Patients
- ClinicalTrials.gov ID
- NCT02842788
- Acronym / sponsor ID
- APRONET / 69HCL16_0468
- Keywords
- prone position, acute respiratory distress syndrome (ARDS), mechanical ventilation, ICU, prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 736 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 25 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS patients receiving invasive mechanical ventilation in ICU | – | Procedure: Prone positioning1. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ARDS under mechanical ventilation
Key inclusion criteria (7 listed)
- 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
- 2.PaO2/FIO2 ≤ 300 with PEEP ≥ 5 cmH2O
- 3.Age ≥ 18 years
- 4.Intubated or tracheotomized and mechanically ventilated
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone positioningTurning the patient face down for several consecutive hours | Procedure or surgery | ARDS patients receiving invasive mechanical ventilation in ICU |
Primary outcome
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
5 secondary outcomes
Prevalence of the use of the prone position in each ARDS category
Time frame: Day 1
Occurence of reasons for not using prone position in ARDS patients
Time frame: Day 1
PaO2
Time frame: Day 1
PaO2/FIO2
Time frame: Day 1
Duration of prone position session
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Guérin, Pr principal investigator
Réanimation médicale, Hôpital de la Croix Rousse, CHU de Lyon, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome (ARDS), run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of the use of the prone position in ARDS (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.