The ACCESSIT Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mechanical Ventilation.
- Who it may be relevant to
- Registry conditions: Respiratory Support. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Role of ACCESsory Muscles in Mechanically Ventilated Patients After Spinal Cord Injury and Trauma: a Physiological Study - The ACCESSIT Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Thickness and thickening fraction of the accessory muscles and their evolution over time during mechanical ventilation after spinal cord injury and spine trauma. [Time frame: 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 outcome measures (2)
- 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. [Time frame: > 72 hours after intensive care unit admission up to 6 weeks from enrollment]
- 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. [Time frame: > 72 hours after intensive care unit admission up to 6 weeks from enrollment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Unity Health Toronto - St. Michael's Hospital — Toronto
Publications
- Schreiber AF, Vieira F, Madotto F, Sousa MLA, Rodrigues A, Ko M, Phoophiboon V, White McFarlan A, Brault C, Subira C, Singh JM, Reid WD, Rigamonti A, Baker A, Witiw CD, Brochard LJ. Respiratory muscle activity and weaning from mechanical ventilation after spinal trauma: the ACCESSIT study. Ann Am Thorac Soc. 2026 Jun 1;23(6):927-940. doi: 10.1093/annalsats/aaoag046. PMID 41723830
Identifiers
NCT: NCT05207046 · 21-226