Prone Position With Different Types of Cushions in Patients With ARDS

Not Applicable

Recruiting

• Conditions: Prone Position; Acute Respiratory Distress Syndrome
• Interventions: Procedure: Prone position with thoraco-abdominal cushion

• Registration Number: NCT06184490
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2023-08-15
• Status Verified: 2023-12
• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2023-12-14
• Last Update Submitted: 2023-12-14
• Study First Posted: 2023-12-28
• Last Update Posted: 2023-12-28
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified prone position	Prone position with thoraco-abdominal cushion	Prone position with lateral support (lateral cushions on the chest, hips and abdomen)

Primary Outcome Measures

Name	Time	Method
Lung recruitment	1 hour before prone - 2 hours before supine	Change in ventilation of dorsal regions of lung (%) assessed by electrical impedance tomography

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil