The ACCESSIT Study

NCT05207046 | Recruiting

• 1 other identifier: 21-226
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Support

Keywords

Spinal cord injury; Trauma; Respiratory muscles; Mechanical ventilation; Acute respiratory failure; Diaphragm dysfunction

Outcome Measures

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).

  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 Outcomes (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.

  > 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.

  > 72 hours after intensive care unit admission up to 6 weeks from enrollment

Study Arms (2)

Patients with spinal cord injury

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

Other: Mechanical Ventilation

Patients with NO spinal cord injury

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

Other: Mechanical Ventilation

Interventions

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.

Patients with NO spinal cord injury; Patients with spinal cord injury

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• Presence of traumatic spine lesion (with and without spinal cord injury)
• Requiring invasive mechanical ventilation, via oro-tracheal or tracheostomy tube,
• years of age or older
• Patient or substitute decision maker able to provide consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

Unity Health Toronto - St. Michael's Hospital

Toronto, Ontario, M5B 1T8, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Wounds and Injuries

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Central Study Contacts

Laurent Brochard, MD, PhD

CONTACT

416-864-5686; Laurent.Brochard@unityhealth.to

Annia Schreiber, MD

CONTACT

annia.schreiber@unityhealth.to

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 26, 2022
• Study Start: December 17, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)