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Awake Prone Positioning for Severe Acute Chest Syndrome (PRONE-ACS)

A

Assistance Publique - Hôpitaux de Paris

Status

Not yet enrolling

Conditions

Sickle Cell Anemia
Acute Chest Syndrome

Treatments

Procedure: Awake prone positioning (APP)

Study type

Interventional

Funder types

Other

Identifiers

NCT06698120
APHP231628
2023-A02167-38 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Awake prone positioning
Experimental group
Treatment:
Procedure: Awake prone positioning (APP)

Trial contacts and locations

1

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Central trial contact

Matthieu Turpin, MD; Muriel Fartoukh, MD, PhD

Data sourced from clinicaltrials.gov

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