Awake Prone Positioning for Severe Acute Chest Syndrome

NCT06698120 | Not Yet Recruiting

• 2 other identifiers: APHP2316282023-A02167-38
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Chest Syndrome; Sickle Cell Anemia

Keywords

Acute Chest Syndrome; Sickle Cell Anemia; Awake Prone Positioning; Electric Impedance

Outcome Measures

Primary Outcomes (1)

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

  28 days

Secondary Outcomes (9)

• Changes in respiratory parameters

  Up to 28 days

• GI measured by EIT

  Up to 28 days

• 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

Study Arms (1)

Awake prone positioning

EXPERIMENTAL

Procedure: Awake prone positioning (APP)

Interventions

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

Awake prone positioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Médecine Intensive Réanimation TENON

Paris, 75020, France

Location

MeSH Terms

Conditions

Acute Chest Syndrome; Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Matthieu Turpin, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Muriel Fartoukh, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

• Alexandre Elabbadi, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Central Study Contacts

Matthieu Turpin, MD

CONTACT

+33156016574; matthieu.turpin@aphp.fr

Muriel Fartoukh, MD, PhD

CONTACT

+33156016574; muriel.fartoukh@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: November 20, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)