About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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)
Trial population
Patients will be enrolled in the Medical-Surgical ICU at Toronto General Hospital.
Trial design
Cohort
Prospective
Treatments tested in this trial
Sonographic measurements
Other interventionDiaphragm thickness, diaphragm tidal thickening fraction, abdominal muscle thickness, rectus femoris cross-sectional area, maximal diaphragm thickening fraction, abdominal muscle thickening fraction
Physiological measurements
Other interventionAirway occlusion pressure, maximal inspiratory pressure, muscle research council score
Biological measurements
Other interventionSkeletal troponin-I
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Duration of ventilation
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.
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.