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Completed

NCT Number: NCT05693038

Brachial Plexus Injury After Prone Positioning

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.

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Key information

Conditions

Brachial Plexus Injury Lung Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nerve Compression Nerve Sheath Neoplasms Neuroma Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electromyography

Diagnostic Test

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 measurement

Diagnostic Test

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

Primary outcomes

  1. Number of patients with signs of brachial plexus injury (BPI)

    Time frame: 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

    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. Safety of swimmer position adopted

    Time frame: The safety of the swimmer position will be evaluated within 24 hours before ICU discharge

    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

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

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

Acronym: BPX

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2023
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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