Brachial Plexus InjuryBPXNCT05693038
Brachial Plexus Injury After Prone Positioning
An observational study of Brachial Plexus Injury and Nerve Compression, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brachial Plexus Injury, Nerve Compression
- What is being tested?
- Electromyography and Muscle strength measurement
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 6 Apr 2022to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted in the ICU with severe ARDS, also secondary to pulmonary involvement of COVID-19, receiving invasive mechanical ventilation and requiring prone positioning to treat hypoxemia, as decided by the medical team.
Who may be able to join
- 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
Who cannot join
- Extracorporeal membrane oxygenation
- Prone positioning performed in other centers
- Prone positioning contraindications
- Neurodegenerative disorders
- Previous known brachial plexus injury
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
Official title: Brachial Plexus Injury After Prone Positioning in Intensive Care Unit: a Prospective Observational Study
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.
Read the 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).
- Conditions
- Brachial Plexus Injury, Nerve Compression
- Being tested
- Electromyography, Muscle strength measurement
- Keywords
- Prone Position, Brachial Plexus, Respiratory Distress Syndrome, Intensive Care Unit, Swimmer position
- Medical subject headings
- Neuroma, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectromyographyDiagnostic 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 measurementDiagnostic test
Muscle strength measure willl be assessed at ICU discharge using hand-held dynamometer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with signs of brachial plexus injury (BPI)
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)
Measured: 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
Secondary outcomes (1)
Safety of swimmer position adopted
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
Measured: The safety of the swimmer position will be evaluated within 24 hours before ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start6 Apr 2022
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brachial Plexus InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filippo Binda, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693038
- Sponsor's protocol ID
- 6057
- Acronym
- BPX
- Status last verified
- Jul 2026
- First submitted
- 29 Dec 2022
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bamford 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.
Chiumello 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.
PubMed 16764731
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brachial Plexus Injury After Prone Positioning in Intensive Care Unit: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05693038
- Acronym / sponsor ID
- BPX / 6057
- Conditions
- Brachial Plexus Injury, Nerve Compression
- Keywords
- Prone Position, Brachial Plexus, Respiratory Distress Syndrome, Intensive Care Unit, Swimmer position
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in the ICU with severe ARDS, also secondary to pulmonary involvement of COVID-19, receiving invasive mechanical ventilation and requiring prone positioning to treat hypoxemia, as decided by the medical team.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Extracorporeal membrane oxygenation
- Prone positioning performed in other centers
- Prone positioning contraindications
- Neurodegenerative disorders
- Previous known brachial plexus injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectromyographyElectromyography (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. | Diagnostic test | – |
| Muscle strength measurementMuscle strength measure willl be assessed at ICU discharge using hand-held dynamometer. | Diagnostic test | – |
Primary outcome
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)
1 secondary outcome
Safety of swimmer position adopted
Time frame: The safety of the swimmer position will be evaluated within 24 hours before ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- 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.
- Background: PubMed 16764731Chiumello 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brachial Plexus Injury and Nerve Compression, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05693038, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.