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NCT Number: NCT05207046

The ACCESSIT Study

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.

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Key information

Conditions

Respiratory Support Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Unity Health Toronto - St. Michael's Hospital

Toronto, Ontario, M5B 1T8, Canada

Location status: Recruiting

Location contact

Laurent Brochard

CONTACT

[email protected]

416 864 5686

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical ventilation

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.

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.

    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

    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).

Secondary 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 enrollment

  2. 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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Annia Schreiber, MD

CONTACT

[email protected]

Laurent Brochard, MD, PhD

CONTACT

[email protected]

416-864-5686

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

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

Acronym: ACCESSIT

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2022
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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