Using different cushions in the prone position for 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
This study is testing how different types of cushions can improve breathing and reduce complications for patients with severe Acute Respiratory Distress Syndrome when they are placed on their stomach.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital de Clinicas de Porto Alegre Academic / other |
| Locations | 1 site (Porto Alegre, Rio Grande Do Sul) |
| Trial ID | NCT06184490 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of different types of cushions during the prone position maneuver in patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS). The prone position is a therapeutic strategy that improves oxygenation and reduces mortality in ARDS patients, but it can lead to complications such as pressure injuries. By utilizing electrical impedance tomography, the study aims to determine how the arrangement of thoraco-abdominal and modified lateral cushions affects lung recruitment and ventilatory mechanics. The findings could help optimize the prone position technique to enhance patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with moderate to severe ARDS who require prone positioning.
Not a fit: Patients with contraindications to the prone position or those with severe ARDS caused by COVID-19 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved ventilation strategies and reduced complications for ARDS patients undergoing prone positioning.
How similar studies have performed: While the prone position is a well-established therapy, this specific approach using different cushion types is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Porto Alegre, Rio Grande Do Sul
- Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande Do Sul, Brazil (Recruiting)
Study contacts
- Principal investigator: Vanessa Martins de de Oliveira — Hospital de Clínicas de Porto Alegre
- Study coordinator: Vanessa Martins de de Oliveira
- Email: vmoliveira@hcpa.edu.br
- Phone: +55519992513723
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.