Awake Prone Positioning for Severe Acute Chest Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years
Major sickle cell anemia (SS, SC, Sβ)
Admission in intensive care unit for ACS
Registered in the French social insurance regime.
Disqualifiers
Pregnant or breastfeeding women
Immediate need for intubation
Impaired vigilance status (Glasgow scale score < 12)
Pneumothorax
Trial design
Design model
Single group
Treatments tested in this trial
Awake prone positioning (APP)
Procedure/Surgery* 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
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Awake prone positioningExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The total duration of APP during the stay in intensive care unit
Time frame
28 daysSecondary outcomes
1
Changes in respiratory parameters
Assessment of respiratory parameters changes
Time frame
Up to 28 days2
GI measured by EIT
Time frame
Up to 28 days3
ΔEELI measured by EIT
Time frame
Up to 28 days4
Pain measurement assessed by visual analog scale,
Time frame
Up to 28 daysSponsors and contacts
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Source ClinicalTrials.gov
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