Respiratory Muscle Structure and Function in Mechanically Ventilated Patients and Long-term Outcomes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Sonographic measurements

    Other intervention

    Diaphragm thickness, diaphragm tidal thickening fraction, abdominal muscle thickness, rectus femoris cross-sectional area, maximal diaphragm thickening fraction, abdominal muscle thickening fraction

  • Physiological measurements

    Other intervention

    Airway occlusion pressure, maximal inspiratory pressure, muscle research council score

  • Biological measurements

    Other intervention

    Skeletal troponin-I

Treatment groups

230 Participants
are divided into 3 treatment groups
Group A: Cases3 interventions
Group B: Control condition A3 interventions
Group C: Control condition B3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 180
2

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.

Time frame
Day 180

Secondary outcomes

1

Duration of ventilation

Time frame
Until hospital discharge (up to 6 months)
2

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.

Time frame
Until day 14
3

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.

Time frame
First spontaneous breathing trial (within 5 minutes of onset)
4

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.

Time frame
First spontaneous breathing trial (within 5 minutes of onset)

Other outcomes

Sponsors and contacts

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