Brachial Plexus Injury After Prone Positioning (BPX)

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.

Study Overview

• Status: Recruiting
• Conditions: Brachial Plexus Injury; Nerve Compression
• Intervention / Treatment: Diagnostic test: Electromyography; Diagnostic test: Muscle strength measurement

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 Type: Observational
• Enrollment (Estimated): 54

Contacts and Locations

• Study Contact: Name: Filippo Binda, MSc; Phone Number: +39 02 5503 4954; Email: filippo.binda@policlinico.mi.it

Study Locations

• Italy
  • Milano, Italy, 20122
    • Recruiting
    • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
    • Contact: Filippo Binda, MSc; Phone Number: +39 02 5503 4954; Email: filippo.binda@policlinico.mi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 29, 2022
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Prone Position; Respiratory Distress Syndrome; Brachial Plexus; Swimmer position
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 6057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No