Evaluating nerve injuries from prone positioning in ICU patients
Brachial Plexus Injury After Prone Positioning in Intensive Care Unit: a Prospective Observational Study
This study looks at whether lying patients with severe breathing problems on their stomachs can cause nerve injuries in their arms and how different arm positions might affect this.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milano) |
| Trial ID | NCT05693038 on ClinicalTrials.gov |
What this trial studies
This observational study aims to estimate the prevalence of brachial plexus injury in patients with acute respiratory distress syndrome (ARDS) after being placed in a prone position. It will assess the safety of the swimmer position during this procedure, focusing on how arm positioning may influence nerve injuries. Participants will undergo electromyography (EMG) assessments at specific time points to evaluate any occurrences of brachial plexus injury. The study follows current guidelines for prone positioning while ensuring patient safety and comfort.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older admitted to the ICU for severe ARDS who require sedation, neuromuscular blocking agents, and mechanical ventilation.
Not a fit: Patients with neurodegenerative disorders or previous known brachial plexus injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety protocols for prone positioning in ICU patients, potentially reducing the incidence of nerve injuries.
How similar studies have performed: While there is limited data on the specific approach of this study, similar observational studies have indicated the importance of positioning in preventing nerve injuries, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old * Admission to ICU for severe ARDS * Administration of sedation and neuromuscular blocking agents * Presence of endotracheal intubation and mechanical ventilation * Use of prone positioning to treat hypoxemia Exclusion Criteria: * Extracorporeal membrane oxygenation * Prone positioning performed in other centers * Prone positioning contraindications * Neurodegenerative disorders * Previous known brachial plexus injury
Where this trial is running
Milano
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Filippo Binda, MSc
- Email: filippo.binda@policlinico.mi.it
- Phone: +39 02 5503 4954
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.