Awake Prone Positioning for Severe Acute Chest Syndrome (PRONE-ACS)

August 25, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Assessment of Efficacy and Safety of Awake Prone Positioning in Sickle Cell Anemia Patient Admitted in Intensive Care Unit 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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Awake prone positioning
Procedure: Awake prone positioning (APP)
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The total duration of APP during the stay in intensive care unit
Time Frame: 28 days
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Chair: Muriel Fartoukh, MD, PhD, Assistance Publique - Hôpitaux de Paris
  • Principal Investigator: Matthieu Turpin, MD, Assistance Publique - Hôpitaux de Paris
  • Study Chair: Alexandre Elabbadi, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP231628
  • 2023-A02167-38 (Other Identifier: IDRCB ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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