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Awake Prone Positioning for Severe Acute Chest Syndrome

Assessment of Efficacy and Safety of Awake Prone Positioning in Sickle Cell Anemia Patient Admitted in Intensive Care Unit for Severe Acute Chest Syndrome

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06698120
Acronym
PRONE-ACS
Enrollment
15
Registered
2024-11-20
Start date
2026-01-31
Completion date
2027-08-31
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Chest Syndrome, Sickle Cell Anemia

Keywords

Acute Chest Syndrome, Sickle Cell Anemia, Awake Prone Positioning, Electric Impedance

Brief 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. 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.

Interventions

PROCEDUREAwake 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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
The total duration of APP during the stay in intensive care unit28 days

Secondary

MeasureTime frameDescription
GI measured by EITUp to 28 days
ΔEELI measured by EITUp to 28 days
Pain measurement assessed by visual analog scale,Up to 28 days
Pain measurement assessed by morphine consumptionUp to 28 days
Changes in respiratory parametersUp to 28 daysAssessment of respiratory parameters changes
Occurrence of skin lesions during the intensive care unit stay28 Days
Occurrence of displacement of devices during the intensive care unit stay28 Days
Occurrence of use of vital support therapy during the intensive care unit stay28 Days
Pain measurement assessed by analgesic therapeutic escalationUp to 28 days

Countries

France

Contacts

Primary ContactMatthieu Turpin, MD
matthieu.turpin@aphp.fr+33156016574
Backup ContactMuriel Fartoukh, MD, PhD
muriel.fartoukh@aphp.fr+33156016574

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026