Awake Prone Positioning for Severe Acute Chest Syndrome

Not Applicable

Not yet recruiting

• Conditions: Acute Chest Syndrome; Sickle Cell Anemia

• Registration Number: NCT06698120
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-04-24
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20
• Study Start: 2025-01
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The total duration of APP during the stay in intensive care unit	28 days

Secondary Outcome Measures

Name	Time	Method
ΔEELI measured by EIT	Up to 28 days
Pain measurement assessed by visual analog scale,	Up to 28 days
Pain measurement assessed by morphine consumption	Up to 28 days
Pain measurement assessed by analgesic therapeutic escalation	Up to 28 days
Occurrence of skin lesions during the intensive care unit stay	28 Days
Occurrence of displacement of devices during the intensive care unit stay	28 Days
Occurrence of use of vital support therapy during the intensive care unit stay	28 Days
GI measured by EIT	Up to 28 days
Changes in respiratory parameters	Up to 28 days	Assessment of respiratory parameters changes

Trial Locations

Locations (1)

Service de Médecine Intensive Réanimation TENON; 🇫🇷 Paris, France