Clinical trial NCT05207046: The ACCESSIT Study
Official title: Role of ACCESsory Muscles in Mechanically Ventilated Patients After Spinal Cord Injury and Trauma: a Physiological Study - The ACCESSIT Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Support
Keywords: Spinal cord injury
Trauma
Respiratory muscles
Mechanical ventilation
Acute respiratory failure
Diaphragm dysfunction
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All mechanically ventilated patients with traumatic spine lesion (with and without spinal cord injury) will be considered for inclusion as early as possible after ICU admission (within 72 hours of admission).

Brief summary: The study is designed to characterize and monitor the structure, degree of activation and function of the different respiratory muscles during mechanical ventilation after spine trauma and spinal cord injury.

Detailed description: In patients with spinal cord injury, separation from mechanical ventilation is an essential aspect of the prognosis. Denervation of specific muscles, as a consequence of the injury, can generate a dysfunction of the involved muscles and/or a disruption of their coordination during breathing. Respiratory muscle dysfunction is strongly associated with failure of weaning from mechanical ventilation. However, the pattern of activation and coordination of the different respiratory muscles, as well as their evolution over time, have been poorly investigated in spinal cord injury, particularly during the acute phase in intensive care unit.

Assessing the structure, activity, and function of the respiratory muscles at different time points after the injury would help to better understand the natural course of respiration in these patients and the possible therapeutic approaches. In fact, depending on the activation/deactivation and residual function of the respiratory muscles, there might be potential for recovery and training, with the possibility of improving patients' clinical outcomes.

In this preliminary physiological study, the investigators aim to assess the feasibility of monitoring non-invasively the respiratory muscles in mechanically ventilated adult patients with traumatic spine lesion, with and without spinal cord injury. The investigators also aim to assess, monitor, and compare over time the structure, degree of activation, function, and coordination of the different respiratory muscles.

Because the diagnosis of spinal cord injury is not always made immediately in spine trauma patients, and because other factors related to chest or abdominal trauma could interfere with the respiratory pattern, the plan is to study and follow patients with spinal cord injury, using patients with traumatic spine lesion without spinal cord injury as controls.

Eligibility criteria: Inclusion Criteria:

* Presence of traumatic spine lesion (with and without spinal cord injury)
* Requiring invasive mechanical ventilation, via oro-tracheal or tracheostomy tube,
* 16 years of age or older
* Patient or substitute decision maker able to provide consent

Exclusion Criteria:

* Expected withdrawal of treatments within 24 hours of screening
* Chronic respiratory failure already treated with mechanical ventilation before the injury
* Documented pre-existing neuromuscular diseases

Primary outcomes:
measure: Thickness and thickening fraction of the accessory muscles and their evolution over time during mechanical ventilation after spinal cord injury and spine trauma.
timeFrame: Baseline measurements assessed ≤ 72 hours from admission and subsequent measurements assessed > 72 hours from intensive care unit admission, until spontaneous unassisted breathing is reached, up to 6 weeks from enrollment
Secondary outcomes:
measure: Timing of activation and coordination of the diaphragm and of the different accessory muscles will be assessed using surface electromyography and monitored over time, after spinal cord injury and spine trauma.
timeFrame: > 72 hours after intensive care unit admission up to 6 weeks from enrollment
measure: Rib cage and abdomen displacement and their coordination will be recorded and monitored over time using respiratory inductive plethysmography, after spinal cord injury and spine trauma.
timeFrame: > 72 hours after intensive care unit admission up to 6 weeks from enrollment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Unity Health Toronto - St. Michael's Hospital
state: Ontario
Study officials:
References: