Clinical trial NCT06698120: Awake Prone Positioning for Severe Acute Chest Syndrome
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Chest Syndrome
Sickle Cell Anemia
Keywords: Acute Chest Syndrome
Sickle Cell Anemia
Awake Prone Positioning
Electric Impedance
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: The total duration of APP during the stay in intensive care unit
timeFrame: 28 days
Secondary outcomes:
measure: Changes in respiratory parameters
timeFrame: Up to 28 days
measure: GI measured by EIT
timeFrame: Up to 28 days
measure: ΔEELI measured by EIT
timeFrame: Up to 28 days
measure: Pain measurement assessed by visual analog scale,
timeFrame: Up to 28 days
measure: Pain measurement assessed by morphine consumption
timeFrame: Up to 28 days
measure: Pain measurement assessed by analgesic therapeutic escalation
timeFrame: Up to 28 days
measure: Occurrence of skin lesions during the intensive care unit stay
timeFrame: 28 Days
measure: Occurrence of displacement of devices during the intensive care unit stay
timeFrame: 28 Days
measure: Occurrence of use of vital support therapy during the intensive care unit stay
timeFrame: 28 Days
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Médecine Intensive Réanimation TENON
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Matthieu Turpin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Muriel Fartoukh, MD, PhD
role: STUDY_CHAIR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alexandre Elabbadi, MD
role: STUDY_CHAIR
References: