The ACCESSIT Study
ConditionRespiratory Support
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorUnity Health Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Mechanical Ventilation
Other interventionPatients 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Patients with spinal cord injury1 intervention
Group B: Patients with NO spinal cord injury1 intervention
Trial outcomes
Primary outcomes
1
Thickness and thickening fraction of the accessory muscles and their evolution over time during mechanical ventilation after spinal cord injury and spine trauma.
Patients with spinal cord injury will be compared to patients with spine trauma and no spinal cord injury, at baseline and at different time points. The evolution of the ultrasound thickness of the respiratory muscles will also be compared to the evolution of the thickness of the limb muscles (rectus femoris). Regarding the primary outcome, patients with spinal cord injury will be compared to patients with spinal trauma and no spinal cord injury at baseline and at different time points. The evolution of the ultrasound thickness of the respiratory muscles will also be compared to the evolution of the thickness of the limb muscles (rectus femoris).
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 enrollmentSecondary outcomes
1
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 enrollment2
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.
Measures to be assessed will be: phase angle, asynchronies and/or paradox of rib cage and abdomen, maximum compartmental amplitude/tidal volume ratio, rib cage/tidal volume ratio (relative contribution of the rib cage to the tidal volume).
Time frame
> 72 hours after intensive care unit admission up to 6 weeks from enrollmentSponsors and contacts
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Source ClinicalTrials.gov