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Brachial Plexus Injury After Prone Positioning

Brachial Plexus Injury After Prone Positioning in Intensive Care Unit: a Prospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05693038
Acronym
BPX
Enrollment
54
Registered
2023-01-20
Start date
2022-04-06
Completion date
2024-12-31
Last updated
2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brachial Plexus Injury, Nerve Compression

Keywords

Prone Position, Brachial Plexus, Respiratory Distress Syndrome, Intensive Care Unit, Swimmer position

Brief summary

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.

Detailed description

Prone positioning will be performed according to the current guidelines. Particularly, face and limbs will be placed according to the swimmer position, ensuring the face position in the direction of ventilator and limbs (one arm above head and opposite arm at side) positioned as to prevent abnormal extension or flexion against the shoulders and elbows. Patients will lie on low air loss pressure mattresses, thus avoiding the utilization of any thoraco-pelvic supports, which are not recommended. Electromyography (EMG) will be performed to evaluate the occurrence of brachial plexus injury (BPI).

Interventions

DIAGNOSTIC_TESTElectromyography

Electromyography (EMG) monitoring will be performed, using the instrumentation available (Nemus 2, EB Neuro, Italy), to evaluate the occurrence of brachial plexus injury (BPI). EMG will be performed at the end of each pronation cycle. To rule out BPI at ICU admission, an EMG will be performed within two hours from the first pronation maneuver. Particularly, somatosensory evoked potential (SSEP) and sensory action potential (SAP) will be obtained from radial, ulnar, median and sural nerves. In case patients are awake, compound muscle action potential (CMAP) will be obtained as well.

Muscle strength measure willl be assessed at ICU discharge using hand-held dynamometer.

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with signs of brachial plexus injury (BPI)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 dischargeSigns 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

MeasureTime frameDescription
Safety of swimmer position adoptedThe safety of the swimmer position will be evaluated within 24 hours before ICU dischargeThe 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

Countries

Italy

Contacts

Primary ContactFilippo Binda, MSc
filippo.binda@policlinico.mi.it+39 02 5503 4954

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026