Brachial Plexus Injury After Prone Positioning

Recruiting

• Conditions: Brachial Plexus Injury; Nerve Compression

• Registration Number: NCT05693038
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

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 Timeline

• Study Start: 2022-04-06
• Study First Submitted: 2022-12-29
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with signs of brachial plexus injury (BPI)	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 Outcome Measures

Name	Time	Method
Safety of swimmer position adopted	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

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy