Awake Prone Positioning for Severe Acute Chest Syndrome

NCT ID: NCT06698120

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-08-31

Brief Summary

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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

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* 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.

Conditions

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Acute Chest Syndrome Sickle Cell Anemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Awake prone positioning

Group Type EXPERIMENTAL

Awake prone positioning (APP)

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthieu Turpin, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Muriel Fartoukh, MD, PhD

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Alexandre Elabbadi, MD

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Locations

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Service de Médecine Intensive Réanimation TENON

Paris, , France

Site Status

Countries

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France

Central Contacts

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Matthieu Turpin, MD

Role: CONTACT

+33156016574

Muriel Fartoukh, MD, PhD

Role: CONTACT

+33156016574

Facility Contacts

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Matthieu Turpin, MD

Role: primary

+33156016574

Muriel FARTOUKH, MD, PhD

Role: backup

+33156016574

Other Identifiers

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2023-A02167-38

Identifier Type: OTHER

Identifier Source: secondary_id

APHP231628

Identifier Type: -

Identifier Source: org_study_id

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