Brachial Plexus Injury After Prone Positioning

NCT ID: NCT05693038

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-06

Study Completion Date

2024-12-31

Brief Summary

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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

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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).

Conditions

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Brachial Plexus Injury Nerve Compression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Muscle strength measurement

Muscle strength measure willl be assessed at ICU discharge using hand-held dynamometer.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

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Filippo Binda

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Filippo Binda, MSc

Role: CONTACT

+39 02 5503 4954

Facility Contacts

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Filippo Binda, MSc

Role: primary

+39 02 5503 4954

References

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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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 16764731 (View on PubMed)

Other Identifiers

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6057

Identifier Type: -

Identifier Source: org_study_id

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