The ACCESSIT Study

NCT ID: NCT05207046

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-17
• Study Completion Date: 2026-06-30

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.

Conditions

Respiratory Support

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with spinal cord injury

Patients treated with mechanical ventilation after a traumatic spine lesion with spinal cord injury

Mechanical Ventilation

Intervention Type: OTHER

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.

Patients with NO spinal cord injury

Patients treated with mechanical ventilation after a traumatic spine lesion with NO spinal cord injury

Mechanical Ventilation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Unity Health Toronto - St. Michael's Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Laurent Brochard, MD, PhD

Role: CONTACT

Laurent.Brochard@unityhealth.to

416-864-5686

Annia Schreiber, MD

Role: CONTACT

annia.schreiber@unityhealth.to

Facility Contacts

Laurent Brochard

Role: primary

Laurent.Brochard@unityhealth.to

416 864 5686

Other Identifiers

21-226

Identifier Type: -

Identifier Source: org_study_id