Respiratory SupportACCESSITNCT05207046
The ACCESSIT Study
An observational study of Respiratory Support, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Respiratory Support
- What is being tested?
- Mechanical Ventilation
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 17 Dec 2021to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Annia Schreiber, MD contact
Canada1 site, 1 recruiting
- Recruiting
Unity Health Toronto - St. Michael's Hospital
Toronto, Ontario, M5B 1T8
Laurent Brochard, 416 864 5686, Laurent.Brochard@unityhealth.to
About this study
Official title: Role of ACCESsory Muscles in Mechanically Ventilated Patients After Spinal Cord Injury and Trauma: a Physiological Study - 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.
Read the 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
- Being tested
- Mechanical Ventilation
- Keywords
- Spinal cord injury, Trauma, Respiratory muscles, Mechanical ventilation, Acute respiratory failure, Diaphragm dysfunction
- Medical subject headings
- Spinal Cord Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical VentilationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with spinal cord injury | Patients treated with mechanical ventilation after a traumatic spine lesion with spinal cord injury Receives: Other: Mechanical Ventilation | |
| Patients with NO spinal cord injury | Patients treated with mechanical ventilation after a traumatic spine lesion with NO spinal cord injury Receives: Other: Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: > 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.
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).
Measured: > 72 hours after intensive care unit admission up to 6 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start17 Dec 2021
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory SupportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207046
- Sponsor's protocol ID
- 21-226
- Acronym
- ACCESSIT
- Status last verified
- May 2025
- First submitted
- 17 Dec 2021
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41723830
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of ACCESsory Muscles in Mechanically Ventilated Patients After Spinal Cord Injury and Trauma: a Physiological Study - The ACCESSIT Study
- ClinicalTrials.gov ID
- NCT05207046
- Acronym / sponsor ID
- ACCESSIT / 21-226
- Conditions
- Respiratory Support
- Keywords
- Spinal cord injury, Trauma, Respiratory muscles, Mechanical ventilation, Acute respiratory failure, Diaphragm dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with spinal cord injury | – | Other: Mechanical VentilationPatients treated with mechanical ventilation after a traumatic spine lesion with spinal cord injury |
| Patients with NO spinal cord injury | – | Other: Mechanical VentilationPatients treated with mechanical ventilation after a traumatic spine lesion with NO spinal cord injury |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical VentilationPatients 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. | Other | Patients with NO spinal cord injury, Patients with spinal cord injury |
Primary outcome
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).
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Derived from this study: PubMed 41723830Schreiber 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annia Schreiber, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Support, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent Brochard, MD, PhD (416-864-5686, Laurent.Brochard@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05207046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.