Prone Position With Different Types of Cushions in Patients With ARDS

Acute Respiratory Distress Syndrome Clinical Trial

— PronEIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06184490
• Other study ID #: 2022-0323
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Vanessa Martins de de Oliveira
• Phone: +55519992513723
• Email: vmoliveira[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Prone Position
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Procedure:
• Prone position with thoraco-abdominal cushion
Prone position with cushions positioned laterally on the chest, abdomen, and pelvis

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung recruitment	Change in ventilation of dorsal regions of lung (%) assessed by electrical impedance tomography	1 hour before prone - 2 hours before supine