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NCT06698120 | NOT YET RECRUITING | Acute Chest Syndrome


Awake Prone Positioning for Severe Acute Chest Syndrome
Sponsor:

Public Assistance - Paris Hospitals

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

Condition or disease

Acute Chest Syndrome

Sickle Cell Anemia

Intervention/treatment

Awake prone positioning (APP)

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-01
Estimated Primary Completion Date : 2025-08
Estimated Study Completion Date : 2026-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

Awake Prone Positioning for Severe Acute Chest Syndrome

Location Details

NCT06698120


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Locations


Not yet recruiting

France,

Intensive Care Medicine Department TENON

Paris, France, 75020

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