Mechanical Ventilation ComplicationRESPIRENCT05857774
Respiratory Muscle Structure and Function in Mechanically Ventilated Patients and Long-term Outcomes
An observational study of Mechanical Ventilation Complication and Diaphragm Injury, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Air is normally pumped in and out of the lungs by the muscles that contribute to inhalation and exhalation, called the respiratory muscles. The abdominal muscles help by forcing air out of your lungs during exhalation; whereas the diaphragm, the main muscle used for breathing, contracts to get air into the lungs… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Diaphragm Injury, Lung Injury
- What is being tested?
- Sonographic measurements, Physiological measurements and Biological measurements
- How many people
- 230 participants
- Where
- 1 siteCanada
- Study dates
- 27 Apr 2023to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be enrolled in the Medical-Surgical ICU at Toronto General Hospital.
Who may be able to join
None listed.
Who cannot join
- Patients expected to be extubated within 24 hours of screening for eligibility
- Patients who have already undergone a SBT at time of screening
- Patients with a previously diagnosed neuromuscular disorder
- Patients receiving long-term invasive mechanical ventilation (prior to current hospitalization)
- Patients who have required previously (during current hospitalization) a period of invasive ventilation in ICU of more than 24 hours
- Patients who have previously been enrolled in the study
- Patients for whom post-hospital follow-up may be challenging, e.g. those who reside overseas or who have no fixed address
Trial locations and contacts
1 site in 1 country.
Catherine Bellissimo, PhD contact
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2N2
Rongyu (Cindy) Jin
About this study
Air is normally pumped in and out of the lungs by the muscles that contribute to inhalation and exhalation, called the respiratory muscles. The abdominal muscles help by forcing air out of your lungs during exhalation; whereas the diaphragm, the main muscle used for breathing, contracts to get air into the lungs during inhalation. With mechanical ventilation, respiratory muscles are able to rest and recover while the breathing machine takes over; however, this may cause respiratory muscle weakness. Patients who develop weakness of these muscles may require more assistance from the ventilator and take longer to recover their ability to breathe without assistance. The impact of this phenomenon on long-term outcomes is uncertain.
The RESPIRE study is designed to characterize how respiratory muscles change during mechanical ventilation and to evaluate the impact on long term quality of life. An additional objective of this study is to examine novel measures obtained from automated functions of a ventilator, that may better predict success from weaning from mechanical ventilation.
Read the detailed description
Previous work has established that diaphragm atrophy during mechanical ventilation is associated with adverse clinical outcomes. Abdominal muscles, which are engaged during breathing also undergo atrophy during mechanical ventilation. However, the relationship between these muscles and how they relate to long term function status is known and warrants further investigation.
Mechanical ventilation is a life-saving technique in patients with respiratory failure, however reasons why some patients require long term ventilation and are unsuccessful from weaning from ventilators are not fully elucidated. Respiratory muscle dysfunction as a result of mechanical ventilation is only recently being understood. Diaphragm atrophy is associated with adverse clinical outcomes, but the same is unknown if this holds true with abdominal muscle atrophy. Properly understanding the natural progression of diaphragm and abdominal muscle atrophy and dysfunction, and how they relate to each other, is critical to identifying markers or factors that may put particular patients at risk for long durations of mechanical ventilation and adverse clinical outcomes.
This study will provide important insights into the relationship between inspiratory and expiratory muscle function, and the evolution of functional impairments in critical care patients undergoing weaning from invasive mechanical ventilation. Further understanding of the pathophysiological processes of how these muscle groups interact in this context is important in moving forward with potential therapeutic strategies aimed at mitigating injury.
- Conditions
- Mechanical Ventilation Complication, Diaphragm Injury, Lung Injury, Respiratory Insufficiency, Abdominal Muscle Strained
- Being tested
- Sonographic measurements, Physiological measurements, Biological measurements
- Medical subject headings
- Lung Injury, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonographic measurementsOther
Diaphragm thickness, diaphragm tidal thickening fraction, abdominal muscle thickness, rectus femoris cross-sectional area, maximal diaphragm thickening fraction, abdominal muscle thickening fraction
Physiological measurementsOther
Airway occlusion pressure, maximal inspiratory pressure, muscle research council score
Biological measurementsOther
Skeletal troponin-I
| Study group | Role | What they receive |
|---|---|---|
| Cases | Adult patients ≥18 years of age undergoing invasive mechanical ventilation in the ICU for any reason within 36 hours of intubation Receives: Other: Sonographic measurements; Other: Physiological measurements; Other: Biological measurements | |
| Control condition A | Non-invasively ventilated patients in the ICU within 36 hours of initiating non-invasive ventilation Receives: Other: Sonographic measurements; Other: Physiological measurements; Other: Biological measurements | |
| Control condition B | Non-ventilated patients admitted to the ICU receiving no respiratory support or oxygen therapy alone, including high flow nasal cannula Receives: Other: Sonographic measurements; Other: Physiological measurements; Other: Biological measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life at home
5-level EQ-5D (EQ-5D-5L) score - The EQ-5D-5L is a validated self-reported instrument assessing quality of life at the moment questionnaire is completed. Each question is scored from 1 (no problems) to 5 (inability to perform activity) and are independently assessed.
Measured: Day 180
Quality of life at home
Montreal Cognitive Assessment (MOCA) score - MoCA is a clinician-reported measure to assess for cognitive impairments. MoCA is scored out of 30 with scores <26 indicating cognitive impairment.
Measured: Day 180
Secondary outcomes (10)
Duration of ventilation
Measured: Until hospital discharge (up to 6 months)
Muscle research council score
Muscle research council score, is a validated measure of muscle strength. Possible scores range from 0 (complete paralysis) to 60 (normal strength). Assessments will be made at first spontaneous breathing trial \& at day 14.
Measured: Until day 14
Airway occlusion pressure (P0.1)
P0.1 will be assessed during spontaneous breathing trial. Spontaneous breathing trials (SBT) are standard of care to assess if patients are able to be extubated from mechanical ventilation. A specific time frame cannot be provided as SBT are only conducted when care team deem the patient as capable.
Measured: First spontaneous breathing trial (within 5 minutes of onset)
Expiratory occlusion pressure (Pocc)
Pocc will be assessed during spontaneous breathing trial. Spontaneous breathing trials (SBT) are standard of care to assess if patients are able to be extubated from mechanical ventilation. A specific time frame cannot be provided as SBT are only conducted when care team deem the patient as capable.
Measured: First spontaneous breathing trial (within 5 minutes of onset)
Maximal inspiratory pressure (MIP)
MIP will be assessed during spontaneous breathing trial. Spontaneous breathing trials (SBT) are standard of care to assess if patients are able to be extubated from mechanical ventilation. A specific time frame cannot be provided as SBT are only conducted when care team deem the patient as capable.
Measured: First spontaneous breathing trial within 30 minutes of onset
Days alive and at home at 180 days post ICU discharge
Measured: Day 180
Changes in abdominal muscle thickening fraction during cough
Abdominal muscle thickening fraction during cough will be assessed by ultrasound during SBT when care team deems patient capable and safe to do so, as such a specific time frame for SBT cannot be provided. Additionally abdominal muscle thickening fraction will be assessed at ICU discharge. A specific time frame cannot be provided as ICU discharge will vary between patients.
Measured: At first spontaneous breathing trial within 30 minutes of onset and at ICU discharge, an average of 7 days
Maximal diaphragm thickening fraction
Maximal diaphragm thickening fraction will be assessed by ultrasound during SBT when care team deems patient capable and safe to do so, as such a specific time frame for SBT cannot be provided. Additionally abdominal muscle thickening fraction will be assessed at ICU discharge. A specific time frame cannot be provided as ICU discharge will vary between patients.
Measured: At first spontaneous breathing trial within 30 minutes of onset and at ICU discharge, an average of 7 days
Changes in resting abdominal muscle thickening
Diaphragm ultrasound to measure thickening of abdominal muscles during resting tidal breathing.
Measured: Until Day 14
Changes in resting thickening fraction
Diaphragm ultrasound to measure thickening fraction during resting tidal breathing.
Measured: Until Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start27 Apr 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewan Goligher, MD, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857774
- Sponsor's protocol ID
- 22-5875
- Acronym
- RESPIRE
- Status last verified
- May 2024
- First submitted
- 2 Mar 2023
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Structure and Function in Mechanically Ventilated Patients and Long-term Outcomes
- ClinicalTrials.gov ID
- NCT05857774
- Acronym / sponsor ID
- RESPIRE / 22-5875
- Conditions
- Mechanical Ventilation Complication, Diaphragm Injury, Lung Injury, Respiratory Insufficiency, Abdominal Muscle Strained
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 May 2023 (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.
Air is normally pumped in and out of the lungs by the muscles that contribute to inhalation and exhalation, called the respiratory muscles. The abdominal muscles help by forcing air out of your lungs during exhalation; whereas the diaphragm, the main muscle used for breathing, contracts to get air into the lungs during inhalation. With mechanical ventilation, respiratory muscles are able to rest and recover while the breathing machine takes over; however, this may cause respiratory muscle weakness. Patients who develop weakness of these muscles may require more assistance from the ventilator and take longer to recover their ability to breathe without assistance. The impact of this phenomenon on long-term outcomes is uncertain.
The RESPIRE study is designed to characterize how respiratory muscles change during mechanical ventilation and to evaluate the impact on long term quality of life. An additional objective of this study is to examine novel measures obtained from automated functions of a ventilator, that may better predict success from weaning from mechanical ventilation.
Detailed description
Previous work has established that diaphragm atrophy during mechanical ventilation is associated with adverse clinical outcomes. Abdominal muscles, which are engaged during breathing also undergo atrophy during mechanical ventilation. However, the relationship between these muscles and how they relate to long term function status is known and warrants further investigation.
Mechanical ventilation is a life-saving technique in patients with respiratory failure, however reasons why some patients require long term ventilation and are unsuccessful from weaning from ventilators are not fully elucidated. Respiratory muscle dysfunction as a result of mechanical ventilation is only recently being understood. Diaphragm atrophy is associated with adverse clinical outcomes, but the same is unknown if this holds true with abdominal muscle atrophy. Properly understanding the natural progression of diaphragm and abdominal muscle atrophy and dysfunction, and how they relate to each other, is critical to identifying markers or factors that may put particular patients at risk for long durations of mechanical ventilation and adverse clinical outcomes.
This study will provide important insights into the relationship between inspiratory and expiratory muscle function, and the evolution of functional impairments in critical care patients undergoing weaning from invasive mechanical ventilation. Further understanding of the pathophysiological processes of how these muscle groups interact in this context is important in moving forward with potential therapeutic strategies aimed at mitigating injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Sonographic measurements, Other: Physiological measurements, Other: Biological measurementsAdult patients ≥18 years of age undergoing invasive mechanical ventilation in the ICU for any reason within 36 hours of intubation |
| Control condition A | – | Other: Sonographic measurements, Other: Physiological measurements, Other: Biological measurementsNon-invasively ventilated patients in the ICU within 36 hours of initiating non-invasive ventilation |
| Control condition B | – | Other: Sonographic measurements, Other: Physiological measurements, Other: Biological measurementsNon-ventilated patients admitted to the ICU receiving no respiratory support or oxygen therapy alone, including high flow nasal cannula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be enrolled in the Medical-Surgical ICU at Toronto General Hospital.
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Patients expected to be extubated within 24 hours of screening for eligibility
- Patients who have already undergone a SBT at time of screening
- Patients with a previously diagnosed neuromuscular disorder
- Patients receiving long-term invasive mechanical ventilation (prior to current hospitalization)
- Patients who have required previously (during current hospitalization) a period of invasive ventilation in ICU of more than 24 hours
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 |
|---|---|---|
| Sonographic measurementsDiaphragm thickness, diaphragm tidal thickening fraction, abdominal muscle thickness, rectus femoris cross-sectional area, maximal diaphragm thickening fraction, abdominal muscle thickening fraction | Other | Cases, Control condition A, Control condition B |
| Physiological measurementsAirway occlusion pressure, maximal inspiratory pressure, muscle research council score | Other | Cases, Control condition A, Control condition B |
| Biological measurementsSkeletal troponin-I | Other | Cases, Control condition A, Control condition B |
Primary outcome
Quality of life at home
Time frame: Day 180
5-level EQ-5D (EQ-5D-5L) score - The EQ-5D-5L is a validated self-reported instrument assessing quality of life at the moment questionnaire is completed. Each question is scored from 1 (no problems) to 5 (inability to perform activity) and are independently assessed.
Quality of life at home
Time frame: Day 180
Montreal Cognitive Assessment (MOCA) score - MoCA is a clinician-reported measure to assess for cognitive impairments. MoCA is scored out of 30 with scores <26 indicating cognitive impairment.
10 secondary outcomes
Duration of ventilation
Time frame: Until hospital discharge (up to 6 months)
Muscle research council score
Time frame: Until day 14
Airway occlusion pressure (P0.1)
Time frame: First spontaneous breathing trial (within 5 minutes of onset)
Expiratory occlusion pressure (Pocc)
Time frame: First spontaneous breathing trial (within 5 minutes of onset)
Maximal inspiratory pressure (MIP)
Time frame: First spontaneous breathing trial within 30 minutes of onset
Days alive and at home at 180 days post ICU discharge
Time frame: Day 180
Changes in abdominal muscle thickening fraction during cough
Time frame: At first spontaneous breathing trial within 30 minutes of onset and at ICU discharge, an average of 7 days
Maximal diaphragm thickening fraction
Time frame: At first spontaneous breathing trial within 30 minutes of onset and at ICU discharge, an average of 7 days
Changes in resting abdominal muscle thickening
Time frame: Until Day 14
Changes in resting thickening fraction
Time frame: Until Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- 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. This study is not recruiting at the moment.
Catherine Bellissimo, PhD contact
Ewan Goligher, MD, PhD principal investigator
University Health Network, Toronto
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 Mechanical Ventilation Complication and Diaphragm Injury, run by University Health Network, 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 0 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongyu (Cindy) Jin (4163404800 ext. 7613, rongyu.jin@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life at home (time frame: Day 180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.