ARDSPROMILDNCT05056090
Effect of Prone Positioning on Mortality in Patients With Mild to Moderate Acute Respiratory Distress Syndrome.
A study testing Patients will receive MV in PP in people with ARDS and Acute Respiratory Distress Syndrome, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Acute respiratory distress syndrome (ARDS) accounts for almost 10% of intensive care units (ICU) admissions. Three ARDS stages have been defined, based on the PaO2/FIO2 ratio measured with positive end-expiratory pressure (PEEP) ≥5 cmH2O: mild (201-300 mmHg), moderate (200-101 mmHg), and severe (≤100mmHg). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Acute Respiratory Distress Syndrome, Intensive Care Unit
- What is being tested?
- Patients will receive MV in PP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 656 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 1 Mar 2024
- Phase
- Interventional
- 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
Who may be able to join
- Age of 18 years or more admitted to ICU.
- ARDS patients meeting the Berlin criteria under invasive mechanical ventilation within the first 24h.
- Mechanically ventilated patients with standard settings: PEEP of 5 cmH2O or more and VT 6 ml/kg PBW and Pplat equal to or below 28-30 cmH2O after intubation.
- PaO2/FIO2 between 150 and 300 mmHg under previous settings within 12 hours after mechanical ventilation standardization.
- Written informed consent obtained from the patient, next of kin/proxy or emergency consent. The patient will be asked to give his consent for the continuation of the trial when his condition will allow.
Who cannot join
- Contra-indication to PP: spine instability; intracranial pressure greater than 20 mmHg; severe facial trauma; hemodynamic instability
- Non-inclusion criteria related to medical condition: Lung transplant; Burns over more than 20% of body surface; Chronic respiratory failure requiring home oxygen supplementation and/or non-invasive ventilation; Underlying disease with death expectancy within one year;
- Other non-inclusion criteria: Therapeutic limitation; inclusion into another interventional study in intubated and ventilated patients with mortality as primary end-point in the last 30 days; previously included in the same study; prone positioning before inclusion.
- Individuals referred to in Articles L. 1121-5 à L. 1121-7 (pregnant women, persons deprived of freedom, minors), adult individuals under protection of law (L. 1121-8 and L. 1122-1-2) (emergency situations) of public health regulation in France
- Patients not affiliated to social security insurance regimen
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Grenoble University Hospital
Grenoble, 38000
Roselyne COLLOMB-MURET, +33476767109, rcollombmuret@chu-grenoble.fr
Pierre NICOLAS, +33476767109, pnicolas@chu-grenoble.fr
About this study
Acute respiratory distress syndrome (ARDS) accounts for almost 10% of intensive care units (ICU) admissions. Three ARDS stages have been defined, based on the PaO2/FIO2 ratio measured with positive end-expiratory pressure (PEEP) ≥5 cmH2O: mild (201-300 mmHg), moderate (200-101 mmHg), and severe (≤100mmHg). They represent 30.0%, 46.6%, and 23.4% of ARDS, respectively.
Mechanical invasive ventilation (MV), the cornerstone of ARDS patient care, has a primary goal to protect the lung from ventilator-induced lung injury (VILI). Delivering MV in a prone position (PP) has been shown to improve oxygenation, protect the lung through a better homogenization of lung stress/strain, and stabilize hemodynamics.
Read more
A meta-analysis of four randomized controlled trials showed beneficial effect of PP vs. supine position (SP) in the most hypoxemic patients. A fifth randomized controlled trial further showed a significant reduction in mortality with PP in ARDS patients with PaO2/FIO2 <150 mmHg, when neuromuscular blockade and long prone positioning sessions were used. Therefore, PP has since been strongly recommended for ARDS patients with PaO2/FIO2 <150 mmHg. Yet, there is limited evidence in patients with mild to moderate ARDS.
There are, however, strong arguments supporting the need for a new trial in ARDS patients with PaO2/FIO2 in the range 150-300 mmHg:
- There is no trial that has specifically tested PP in this ARDS subset;
- PP is safe and has become a standard of care in ICU;
- Should VILI prevention be a mechanism through which PP improves survival, this should be involved in all ARDS patients;
- The mortality at hospital discharge in this subset of ARDS remains significant, amounting to 34.9% (95% confidence intervals 31.4-38.5%) in mild and 40.3% (37.4-43.3) in moderate stages;
- Among 580 patients with mild ARDS at admission to the ICU, in-hospital mortality was 10%, 30%, and 37% for those who improved, persisted, and worsened ARDS, respectively.
- Finally, PP has been shown to be cost-effective under commonly accepted thresholds.
The hypothesis is that in patients within the 150-300mmHg PaO2/FIO2 range at the time of ARDS diagnosis, PP can reduce mortality as compared to a similar group left in the SP.
- Being tested
- Patients will receive MV in PP
- Keywords
- ARDS, Acute Respiratory Distress Syndrome, Intensive Care Unit, ICU, Prone position
- 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.
Patients will receive MV in PPProcedure or surgery
Putting the patient in a prone position
| Study group | Role | What they receive |
|---|---|---|
| Patients will receive MV in PP | Experimental | Patients assigned to the intervention group will be turned in PP within the two hours after randomization for at least 16 consecutive hours. Then, patients will be turned in SP. Then, PP sessions are repeated as long as stopping criteria for PP are not met Receives: Procedure: Patients will receive MV in PP |
| Patients will receive MV in SP | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality 28 days after inclusion
Measured: 28 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Sep 2021
- Primary completion28 Sep 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, multicenter, open label trial
- Masking
- None (open label)
- Enrolment
- 656 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas TERZI, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056090
- Sponsor's protocol ID
- 38RC20.366
- Acronym
- PROMILD
- Status last verified
- Nov 2022
- First submitted
- 14 Sep 2021
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prone Positioning on Mortality in Patients With Mild to Moderate Acute Respiratory Distress Syndrome.
- ClinicalTrials.gov ID
- NCT05056090
- Acronym / sponsor ID
- PROMILD / 38RC20.366
- Keywords
- ARDS, Acute Respiratory Distress Syndrome, Intensive Care Unit, ICU, Prone position
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 656 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Sep 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 24 Sep 2021 (actual)
- 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.
Acute respiratory distress syndrome (ARDS) accounts for almost 10% of intensive care units (ICU) admissions. Three ARDS stages have been defined, based on the PaO2/FIO2 ratio measured with positive end-expiratory pressure (PEEP) ≥5 cmH2O: mild (201-300 mmHg), moderate (200-101 mmHg), and severe (≤100mmHg). They represent 30.0%, 46.6%, and 23.4% of ARDS, respectively.
Mechanical invasive ventilation (MV), the cornerstone of ARDS patient care, has a primary goal to protect the lung from ventilator-induced lung injury (VILI). Delivering MV in a prone position (PP) has been shown to improve oxygenation, protect the lung through a better homogenization of lung stress/strain, and stabilize hemodynamics.
A meta-analysis of four randomized controlled trials showed beneficial effect of PP vs. supine position (SP) in the most hypoxemic patients. A fifth randomized controlled trial further showed a significant reduction in mortality with PP in ARDS patients with PaO2/FIO2 <150 mmHg, when neuromuscular blockade and long prone positioning sessions were used. Therefore, PP has since been strongly recommended for ARDS patients with PaO2/FIO2 <150 mmHg. Yet, there is limited evidence in patients with mild to moderate ARDS.
There are, however, strong arguments supporting the need for a new trial in ARDS patients with PaO2/FIO2 in the range 150-300 mmHg:
- There is no trial that has specifically tested PP in this ARDS subset;
- PP is safe and has become a standard of care in ICU;
- Should VILI prevention be a mechanism through which PP improves survival, this should be involved in all ARDS patients;
- The mortality at hospital discharge in this subset of ARDS remains significant, amounting to 34.9% (95% confidence intervals 31.4-38.5%) in mild and 40.3% (37.4-43.3) in moderate stages;
- Among 580 patients with mild ARDS at admission to the ICU, in-hospital mortality was 10%, 30%, and 37% for those who improved, persisted, and worsened ARDS, respectively.
- Finally, PP has been shown to be cost-effective under commonly accepted thresholds.
The hypothesis is that in patients within the 150-300mmHg PaO2/FIO2 range at the time of ARDS diagnosis, PP can reduce mortality as compared to a similar group left in the SP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, randomized, multicenter, open label trial
| Arm | Type | Receives |
|---|---|---|
| Patients will receive MV in PP | Experimental | Procedure: Patients will receive MV in PPPatients assigned to the intervention group will be turned in PP within the two hours after randomization for at least 16 consecutive hours. Then, patients will be turned in SP. Then, PP sessions are repeated as long as stopping criteria for PP are not met |
| Patients will receive MV in SP | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of 18 years or more admitted to ICU.
- ARDS patients meeting the Berlin criteria under invasive mechanical ventilation within the first 24h.
- Mechanically ventilated patients with standard settings: PEEP of 5 cmH2O or more and VT 6 ml/kg PBW and Pplat equal to or below 28-30 cmH2O after intubation.
- PaO2/FIO2 between 150 and 300 mmHg under previous settings within 12 hours after mechanical ventilation standardization.
- Written informed consent obtained from the patient, next of kin/proxy or emergency consent. The patient will be asked to give his consent for the continuation of the trial when his condition will allow.
Key exclusion criteria (5 listed)
- Contra-indication to PP: spine instability; intracranial pressure greater than 20 mmHg; severe facial trauma; hemodynamic instability
- Non-inclusion criteria related to medical condition: Lung transplant; Burns over more than 20% of body surface; Chronic respiratory failure requiring home oxygen supplementation and/or non-invasive ventilation; Underlying disease with death expectancy within one year;
- Other non-inclusion criteria: Therapeutic limitation; inclusion into another interventional study in intubated and ventilated patients with mortality as primary end-point in the last 30 days; previously included in the same study; prone positioning before inclusion.
- Individuals referred to in Articles L. 1121-5 à L. 1121-7 (pregnant women, persons deprived of freedom, minors), adult individuals under protection of law (L. 1121-8 and L. 1122-1-2) (emergency situations) of public health regulation in France
- Patients not affiliated to social security insurance regimen
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 |
|---|---|---|
| Patients will receive MV in PPPutting the patient in a prone position | Procedure or surgery | Patients will receive MV in PP |
Primary outcome
All-cause mortality
Time frame: 28 days after inclusion
All-cause mortality 28 days after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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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.
Nicolas TERZI principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients will receive MV in PP in people with ARDS and Acute Respiratory Distress Syndrome, run by University Hospital, Grenoble 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura CHAMBON (+33476768955, lchambon@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 28 days after inclusion). 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 7 Nov 2022.