Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT06698120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-02
First Post:
2024-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Awake Prone Positioning for Severe Acute Chest Syndrome
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRONE-ACS
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
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-A02167-38 | OTHER | IDRCB ANSM | View |