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NCT Number: NCT06698120

Awake Prone Positioning 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

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Key information

Conditions

Acute Chest Syndrome Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Lung Diseases Respiration Disorders Respiratory Tract Diseases Sickle Cell Anemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Awake prone positioning (APP)

Procedure
  • 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

Primary outcomes

  1. The total duration of APP during the stay in intensive care unit

    Time frame: 28 days

Secondary outcomes

  1. Changes in respiratory parameters

    Time frame: Up to 28 days

    Assessment of respiratory parameters changes

  2. GI measured by EIT

    Time frame: Up to 28 days

  3. ΔEELI measured by EIT

    Time frame: Up to 28 days

  4. Pain measurement assessed by visual analog scale,

    Time frame: Up to 28 days

  5. Pain measurement assessed by morphine consumption

    Time frame: Up to 28 days

  6. Pain measurement assessed by analgesic therapeutic escalation

    Time frame: Up to 28 days

  7. Occurrence of skin lesions during the intensive care unit stay

    Time frame: 28 Days

  8. Occurrence of displacement of devices during the intensive care unit stay

    Time frame: 28 Days

  9. Occurrence of use of vital support therapy during the intensive care unit stay

    Time frame: 28 Days

Study contacts

Contact information is provided by the study sponsor or research team.

Matthieu Turpin, MD

CONTACT

[email protected]

+33156016574

Muriel Fartoukh, MD, PhD

CONTACT

[email protected]

+33156016574

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: PRONE-ACS

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Nov 20, 2024
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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