Clinical trial NCT05693038: Brachial Plexus Injury After Prone Positioning
Official title: Brachial Plexus Injury After Prone Positioning in Intensive Care Unit: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brachial Plexus Injury
Nerve Compression
Keywords: Prone Position
Brachial Plexus
Respiratory Distress Syndrome
Intensive Care Unit
Swimmer position
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with signs of brachial plexus injury (BPI)
timeFrame: 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 outcomes:
measure: Safety of swimmer position adopted
timeFrame: The safety of the swimmer position will be evaluated within 24 hours before ICU discharge
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
References:
citation: 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.
citation: 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.