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Prone Position With Different Types of Cushions in Patients With ARDS

Prone Position With Different Types of Cushions in Patients With Acute Respiratory Distress Syndrome - Effects on Mechanics, Oxygenation, and Electrical Impedance Tomography Imaging

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06184490
Acronym
PronEIT
Enrollment
12
Registered
2023-12-28
Start date
2023-08-15
Completion date
2025-12-31
Last updated
2023-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Prone Position

Brief summary

The prone maneuver is a well-established therapy in ARDS. Traditionally, the maneuver is perform with thoraco-abdominal cushions. The goal of this study is assess, using electrical impedance tomography, whether the arrangement mode of the cushions alters lung recruitment during the prone maneuver in patients with moderate to severe ARDS.

Detailed description

The prone position is a ventilatory therapeutic strategy used in the treatment of patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) that promotes improved oxygenation with consequent reduction in mortality. Despite being safe and effective, it is not without complications, with pressure injuries being one of the main concerns. The use of cushions helps prevent such injuries, but they can interfere with ventilatory mechanics depending on where they are placed. The aim of this study is to assess whether there is a difference in ventilatory mechanics when performing the prone maneuver with a thoraco-abdominal cushion or a modified lateral cushion, based on measurements from electrical impedance tomography (EIT), gasometric data, and parameters of mechanical ventilation.

Interventions

PROCEDUREProne position with thoraco-abdominal cushion

Prone position with cushions positioned laterally on the chest, abdomen, and pelvis

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients aged 18 years or more, with * moderate or severe acute respiratory distress syndrome (ARDS), and * indication of prone position

Exclusion criteria

* Contra-indication to the prone position: intracranial pressure \> 30 mmHg or cerebral perfusion pressure \< 60 mmHg; massive haemoptysis needing urgent surgical or radiological treatment; tracheal or thoracic surgery in the last 15 days; facial trauma or surgery in the last 15 days; deep venous thrombosis or pulmonary embolism treated in the last 2 days; unstable bone dislocations of rachis, femur, rib cage, pelvis; mean systolic arterial pressure less than 70 mmHg despite vasopressive therapy and pregnancy * Severe acute respiratory distress syndrome (ARDS) caused b coronavirus disease 2019 (despite meeting the Berlin criteria for ARDS, their ventilatory mechanics are characterized by nearly normal compliance, something rarely seen in patients with ARDS from other etiologies) * contraindications for the use of Electrical Impedance Tomography (EIT) such as presence of a cardiac implantable electronic device * Pulmonary transplantation * Prone position before enrollment

Design outcomes

Primary

MeasureTime frameDescription
Lung recruitment1 hour before prone - 2 hours before supineChange in ventilation of dorsal regions of lung (%) assessed by electrical impedance tomography

Countries

Brazil

Contacts

Primary ContactVanessa Martins de de Oliveira
vmoliveira@hcpa.edu.br+55519992513723
Backup ContactMariana Berger do Rosário
mrosario@hcpa.edu.br+5554999508966

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026