Brachial Plexus Injury After Prone Positioning

Brachial Plexus Injury Clinical Trial

— BPX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05693038
• Other study ID #: 6057
• Status: Recruiting
• Start date: April 6, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Filippo Binda, MSc
• Phone: +39 02 5503 4954
• Email: filippo.binda[@]policlinico.mi.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brachial Plexus Injury
• Nerve Compression
• Wounds and Injuries

Intervention

Diagnostic Test:
• Electromyography
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
Muscle strength measure willl be assessed at ICU discharge using hand-held dynamometer.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & 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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	The safety of the swimmer position will be evaluated within 24 hours before ICU discharge