BPX: Brachial Plexus Injury After Prone Positioning

Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (Other)
Overall Status
Recruiting
CT.gov ID
NCT05693038
Collaborator
(none)
54
1
31.9
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
54 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Brachial Plexus Injury After Prone Positioning in Intensive Care Unit: a Prospective Observational Study
Actual Study Start Date :
Apr 6, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano Italy 20122

Sponsors and Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Filippo Binda, Principal Investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier:
NCT05693038
Other Study ID Numbers:
  • 6057
First Posted:
Jan 20, 2023
Last Update Posted:
Jan 20, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Filippo Binda, Principal Investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2023