Clinical Trials Directory

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UnknownNCT05693038

Brachial Plexus Injury After Prone Positioning

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

Status
Unknown
Phase
Study type
Observational
Enrollment
54 (estimated)
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTElectromyographyElectromyography (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_TESTMuscle strength measurementMuscle strength measure willl be assessed at ICU discharge using hand-held dynamometer.

Timeline

Start date
2022-04-06
Primary completion
2024-12-01
Completion
2024-12-01
First posted
2023-01-20
Last updated
2024-02-15

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05693038. Inclusion in this directory is not an endorsement.