NCT05207046

The ACCESSIT Study

Role of ACCESsory Muscles in Mechanically Ventilated Patients After Spinal Cord Injury and Trauma: a Physiological Study - The ACCESSIT Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Support

Interventions

Type	Name	Description
OTHER	Mechanical Ventilation	Patients will be assessed and measurements will be taken during controlled ventilation (most likely \<72 hours of ICU admission), during partially assisted ventilation, and until spontaneous unassisted breathing is reached.

Timeline

• Start date: 2021-12-17
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2022-01-26
• Last updated: 2025-05-20

Locations

1 site across 1 country: Canada