Clinical trial · Observational
Brachial Plexus Injury After Prone Positioning
Brachial Plexus Injury After Prone Positioning in Intensive Care Unit: a Prospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this prospective observational study is to estimate the prevalence of brachial plexus injury after prone positioning in patients with ARDS and to evaluate the safety of swimmer position. The main questions it aims to answer are: * Could arm positioning during pronation play a role in the development of any nerve injury at the brachial plexus level? * Is swimmer position safe when adopted during prone positioning? Participants will be studied at selective time points using EMG assessment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brachial Plexus Injury | — | UNRESOLVED | — |
| Nerve Compression | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electromyography | Diagnostic Test | — | UNRESOLVED |
| Muscle strength measurement | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of patients with signs of brachial plexus injury (BPI)
- timeFrame
- EMG will be perform at the end of the every cycle of prone positioning (each cycle is 16 hours on average) and within 24 hours before ICU discharge
- description
- Signs of BPI are the presence of (almost one of four EMG results): * Somatosensory Evoked Potential N20 latency of radial nerve and ulnar nerve \> 10% compared to baseline * Somatosensory Evoked Potential N20 amplitude of radial nerve and ulnar nerve \< 50% compared to baseline * Sensory Action Potential amplitude of radial nerve, ulnar nerve and median nerve \< 50% compared to baseline * Compound Motor Action Potential amplitude of ulnar and median nerve \< 50% compared to normative data (assessed before ICU discharge)
Secondary outcomes (1)
- measure
- Safety of swimmer position adopted
- timeFrame
- The safety of the swimmer position will be evaluated within 24 hours before ICU discharge
- description
- The safety is defined in terms of: * number of patients with adverse events during prone positioning * number of patients with pressure ulcers after prone positioning * number of patients with ocular damage after prone positioning * number of patients with auricle damage after prone positioning
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDBamford P, Denmade C, Newmarch C, Shirley P, Singer B, Webb S, et al. Guidance For Prone Positioning in Adult Critical Care. Intensive Care Soc. 2019;1-39.
- BACKGROUNDChiumello D, Cressoni M, Racagni M, Landi L, Li Bassi G, Polli F, Carlesso E, Gattinoni L. Effects of thoraco-pelvic supports during prone position in patients with acute lung injury/acute respiratory distress syndrome: a physiological study. Crit Care. 2006;10(3):R87. doi: 10.1186/cc4933. Epub 2006 Jun 8. PMID 16764731