Actively Recruiting
Respiratory Muscle Structure and Function in Mechanically Ventilated Patients and Long-term Outcomes
Led by University Health Network, Toronto · Updated on 2024-05-21
230
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how respiratory muscles, including the diaphragm and abdominal muscles, change during mechanical ventilation and how these changes affect long-term quality of life. The trial aims to better understand muscle weakness caused by mechanical ventilation, which may increase the need for ventilator support and delay recovery. The study focuses on patients receiving invasive or non-invasive ventilation or no respiratory support in intensive care units. Participants include adults aged 18 or older who are in the ICU either undergoing invasive mechanical ventilation within 36 hours of intubation, non-invasive ventilation within 36 hours of starting, or not ventilated but receiving oxygen therapy. The study uses sonographic, physiological, and biological measurements to assess muscle thickness and function. These assessments occur during spontaneous breathing trials and ICU stays, with follow-up to evaluate muscle changes and recovery. During the study, participants will undergo measurements including diaphragm and abdominal muscle thickness, maximal inspiratory pressures, and airway pressures. Quality of life at 180 days after ICU discharge is a primary outcome, along with duration of ventilation and muscle strength scores. Researchers also monitor muscle function and breathing effort during ICU stay, with data collected up to six months post-discharge to understand long-term outcomes and recovery patterns.
CONDITIONS
Brief Title
Respiratory Muscle Structure and Function in Mechanically Ventilated Patients and Long-term Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years or older undergoing invasive mechanical ventilation in the ICU within 36 hours of intubation
- Adult patients 18 years or older receiving non-invasive ventilation in the ICU within 36 hours of starting ventilation
- Adult patients 18 years or older admitted to the ICU not ventilated but receiving no respiratory support or oxygen therapy alone, including high flow nasal cannula
You will not qualify if you...
- Patients expected to be extubated within 24 hours of screening
- Patients who have already undergone a spontaneous breathing trial at screening
- Patients with a previously diagnosed neuromuscular disorder
- Patients receiving long-term invasive mechanical ventilation before current hospitalization
- Patients who required invasive ventilation in ICU for more than 24 hours during current hospitalization
- Patients previously enrolled in the study
- Patients for whom post-hospital follow-up may be difficult, such as those living overseas or without a fixed address
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months or until hospital discharge
Participants undergoing invasive or non-invasive mechanical ventilation, or those receiving no respiratory support, have their respiratory and abdominal muscle function assessed using sonographic, physiological, and biological measurements during their ICU stay.
Assessments during ICU stay and at hospital discharge
Duration - Up to 180 days post ICU discharge
Participants' quality of life and functional status are evaluated at home after ICU discharge to understand long-term outcomes related to respiratory muscle function.
Follow-up assessments at Day 180
Trial Site Locations
Total: 1 location
1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Actively Recruiting
Research Team
R
Rongyu (Cindy) Jin
C
Catherine Bellissimo, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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