Acute Chest SyndromePRONE-ACSNCT06698120
Awake Prone Positioning for Severe Acute Chest Syndrome
A study testing Awake prone positioning (APP) in people with Acute Chest Syndrome and Sickle Cell Anemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Acute chest syndrome (ACS) is the leading cause of admission to intensive care and the leading cause of death in patients with sickle cell disease. Irrespective of the cause of ACS, there is an heterogeneity in pulmonary ventilation/perfusion ratios, leading to worsening of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Chest Syndrome, Sickle Cell Anemia
- What is being tested?
- Awake prone positioning (APP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 >18 years
- Major sickle cell anemia (SS, SC, Sβ)
- Admission in intensive care unit for ACS
- Registered in the French social insurance regime.
- Written, informed consent
Who cannot join
- Pregnant or breastfeeding women
- Immediate need for intubation
- Impaired vigilance status (Glasgow scale score < 12)
- Pneumothorax
- Haemodynamically unstable
- Thoracic trauma admission
- Severely obese with body-mass index higher than 40 kg/m²
- EIT contraindication: pacemaker, automatic implantable defibrillators, skin lesions facing the EIT belt, unstable rachis fracture or medullary lesions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service de Médecine Intensive Réanimation TENON
Paris, 75020
Matthieu Turpin, MD, +33156016574, matthieu.turpin@aphp.fr
Muriel FARTOUKH, MD, PhD, +33156016574, muriel.fartoukh@aphp.fr
About this study
Official title: Assessment of Efficacy and Safety of Awake Prone Positioning in Sickle Cell Anemia Patient Admitted in Intensive Care Unit for Severe Acute Chest Syndrome
Acute chest syndrome (ACS) is the leading cause of admission to intensive care and the leading cause of death in patients with sickle cell disease. Irrespective of the cause of ACS, there is an heterogeneity in pulmonary ventilation/perfusion ratios, leading to worsening of the disease.
Efficiency of awake prone positioning (APP) in acute respiratory failure (ARF) was particularly highlighted during the COVID-19 pandemic. Several physiological factors contribute to this benefit including an improvement in ventilatory drive and gas exchange.
The investigator hypothesize that APP could lead to clinical improvement in ACS in terms of oxygenation and ventilatory drive, by improving the heterogeneity of ventilation
Read the detailed description
- Several physiological mechanisms contribute to the benefit of APP during ARF. In addition to hypoxemia improvement, there is also an effect on ventilatory drive, notably in terms of polypnea, ROX index and inspiratory effort.
- Considering that hypoxemia in ACS contributes to the physiopathological process: deoxygenation of haemoglobin S - red blood cells falciformisation - vaso-occlusive event, APP could be an additional therapy in severe ACS. In addition, improving ventilation-perfusion ratios, mainly by recruiting dorsal zones, could be particularly useful in ACS, where pulmonary damage predominates in gravito-dependent zones.
- Conditions
- Acute Chest Syndrome, Sickle Cell Anemia
- Being tested
- Awake prone positioning (APP)
- Keywords
- Acute Chest Syndrome, Sickle Cell Anemia, Awake Prone Positioning, Electric Impedance
- Medical subject headings
- Acute Chest Syndrome, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake prone positioning (APP)Procedure or surgery
- APP are realized following the diagnosis of ACS
- Prone positioning or supine positioning are performed under supervision of a physician or a nurse
- Maximum session duration: 16 hours per day
- Sessions of prone positioning can be shortened, if necessary (30 minutes minimum), for better tolerance
- Tolerance of prone positioning is assessed by the physician in charge and sessions and may be stopped in case of poor tolerance
| Study group | Role | What they receive |
|---|---|---|
| Awake prone positioning | Experimental | Not described Receives: Procedure: Awake prone positioning (APP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total duration of APP during the stay in intensive care unit
Measured: 28 days
Secondary outcomes (9)
Changes in respiratory parameters
Assessment of respiratory parameters changes
Measured: Up to 28 days
GI measured by EIT
Measured: Up to 28 days
ΔEELI measured by EIT
Measured: Up to 28 days
Pain measurement assessed by visual analog scale,
Measured: Up to 28 days
Pain measurement assessed by morphine consumption
Measured: Up to 28 days
Pain measurement assessed by analgesic therapeutic escalation
Measured: Up to 28 days
Occurrence of skin lesions during the intensive care unit stay
Measured: 28 Days
Occurrence of displacement of devices during the intensive care unit stay
Measured: 28 Days
Occurrence of use of vital support therapy during the intensive care unit stay
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study startJan 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Chest SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Turpin, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisMuriel Fartoukh, MD, PhD, Study chair, Assistance Publique - Hôpitaux de ParisAlexandre Elabbadi, MD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698120
- Sponsor's protocol ID
- APHP231628
- Other IDs
- 2023-A02167-38
- Acronym
- PRONE-ACS
- Status last verified
- Aug 2025
- First submitted
- 24 Apr 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy and Safety of Awake Prone Positioning in Sickle Cell Anemia Patient Admitted in Intensive Care Unit for Severe Acute Chest Syndrome
- ClinicalTrials.gov ID
- NCT06698120
- Acronym / sponsor ID
- PRONE-ACS / APHP231628
- Conditions
- Acute Chest Syndrome, Sickle Cell Anemia
- Keywords
- Acute Chest Syndrome, Sickle Cell Anemia, Awake Prone Positioning, Electric Impedance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 20 Nov 2024 (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 chest syndrome (ACS) is the leading cause of admission to intensive care and the leading cause of death in patients with sickle cell disease. Irrespective of the cause of ACS, there is an heterogeneity in pulmonary ventilation/perfusion ratios, leading to worsening of the disease.
Efficiency of awake prone positioning (APP) in acute respiratory failure (ARF) was particularly highlighted during the COVID-19 pandemic. Several physiological factors contribute to this benefit including an improvement in ventilatory drive and gas exchange.
The investigator hypothesize that APP could lead to clinical improvement in ACS in terms of oxygenation and ventilatory drive, by improving the heterogeneity of ventilation
Detailed description
- Several physiological mechanisms contribute to the benefit of APP during ARF. In addition to hypoxemia improvement, there is also an effect on ventilatory drive, notably in terms of polypnea, ROX index and inspiratory effort.
- Considering that hypoxemia in ACS contributes to the physiopathological process: deoxygenation of haemoglobin S - red blood cells falciformisation - vaso-occlusive event, APP could be an additional therapy in severe ACS. In addition, improving ventilation-perfusion ratios, mainly by recruiting dorsal zones, could be particularly useful in ACS, where pulmonary damage predominates in gravito-dependent zones.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Awake prone positioning | Experimental | Procedure: Awake prone positioning (APP) |
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 >18 years
- Major sickle cell anemia (SS, SC, Sβ)
- Admission in intensive care unit for ACS
- Registered in the French social insurance regime.
- Written, informed consent
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding women
- Immediate need for intubation
- Impaired vigilance status (Glasgow scale score < 12)
- Pneumothorax
- Haemodynamically unstable
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 |
|---|---|---|
| Awake prone positioning (APP)* APP are realized following the diagnosis of ACS * Prone positioning or supine positioning are performed under supervision of a physician or a nurse * Maximum session duration: 16 hours per day * Sessions of prone positioning can be shortened, if necessary (30 minutes minimum), for better tolerance * Tolerance of prone positioning is assessed by the physician in charge and sessions and may be stopped in case of poor tolerance | Procedure or surgery | Awake prone positioning |
Primary outcome
The total duration of APP during the stay in intensive care unit
Time frame: 28 days
9 secondary outcomes
Changes in respiratory parameters
Time frame: Up to 28 days
GI measured by EIT
Time frame: Up to 28 days
ΔEELI measured by EIT
Time frame: Up to 28 days
Pain measurement assessed by visual analog scale,
Time frame: Up to 28 days
Pain measurement assessed by morphine consumption
Time frame: Up to 28 days
Pain measurement assessed by analgesic therapeutic escalation
Time frame: Up to 28 days
Occurrence of skin lesions during the intensive care unit stay
Time frame: 28 Days
Occurrence of displacement of devices during the intensive care unit stay
Time frame: 28 Days
Occurrence of use of vital support therapy during the intensive care unit stay
Time frame: 28 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Matthieu Turpin, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Muriel Fartoukh, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
Alexandre Elabbadi, MD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Awake prone positioning (APP) in people with Acute Chest Syndrome and Sickle Cell Anemia, run by Assistance Publique - Hôpitaux de Paris 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 8 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: opening soon, as of the sponsor's last update on 2 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthieu Turpin, MD (+33156016574, matthieu.turpin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total duration of APP during the stay in intensive care unit (time frame: 28 days). 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 2 Sep 2025.