Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
54 participants
OBSERVATIONAL
2022-04-06
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neurostimulation for Treatment of Chronic Upper Limb Pain After Brachial Plexus Injury
NCT04733599
The Diagnosis and Incidence of Critical Illness Polyneuromyopathy in Medical and Neurosurgical ICU Patients
NCT02634658
Effects of an Eccentric Muscle Strengthening Protocol on Force Moment, Muscle Activation and Plantar Flexor Structure of Patients With Central Nervous System Injuries.
NCT06099340
Stem Cell Therapy to Improve the Muscle Function of Patients With Partly Denervated Muscles of the Arm
NCT00755586
CPAx: Responsiveness and Minimal Clinically Important Difference
NCT06419699
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Prone positioning performed in other centers
* Prone positioning contraindications
* Neurodegenerative disorders
* Previous known brachial plexus injury
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Filippo Binda
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6057
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.