Brachial Plexus Injury After Prone Positioning

NCT05693038 | Recruiting

• 1 other identifier: 6057
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Brachial Plexus Injury; Nerve Compression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  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 of the swimmer position will be evaluated within 24 hours before ICU discharge

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Extracorporeal membrane oxygenation
• Prone positioning performed in other centers
• Prone positioning contraindications
• Neurodegenerative disorders
• Previous known brachial plexus injury

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 16764731 BACKGROUND

MeSH Terms

Conditions

Neuroma; Respiratory Distress Syndrome

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Central Study Contacts

Filippo Binda, MSc

CONTACT

+39 02 5503 4954; filippo.binda@policlinico.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 20, 2023
• Study Start: April 6, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)