Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT05857774

Conditions

Mechanical Ventilation Complication

Diaphragm Injury

Lung Injury

Respiratory Insufficiency

Abdominal Muscle Strained

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sonographic measurements

Physiological measurements

Biological measurements

Study Details

Brief 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 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.

Conditions

Mechanical Ventilation Complication

Diaphragm Injury

Lung Injury

Respiratory Insufficiency

Abdominal Muscle Strained

Study ID

NCT05857774

Start date

Apr 27, 2023

Status verified date

May, 2024

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Cases Inclusion Criteria:

• Adult patients ≥18 years of age undergoing invasive mechanical ventilation in the ICU for any reason within 36 hours of intubation

Control condition A Inclusion Criteria:

• Non-invasively ventilated patients in the ICU within 36 hours of initiating non-invasive ventilation

Control condition B Inclusion Criteria

• Non-ventilated patients admitted to the ICU receiving no respiratory support or oxygen therapy alone, including high flow nasal cannula

Exclusion Criteria:

  • 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

Study Design

Enrollment

230 participants

Anticipated

Interventions and Outcome Measures

Arms

Cases

Adult patients ≥18 years of age undergoing invasive mechanical ventilation in the ICU for any reason within 36 hours of intubation

Control condition A

Non-invasively ventilated patients in the ICU within 36 hours of initiating non-invasive ventilation

Control condition B

Non-ventilated patients admitted to the ICU receiving no respiratory support or oxygen therapy alone, including high flow nasal cannula

Interventions

Sonographic measurements

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

Physiological measurements

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

Biological measurements

Skeletal troponin-I

Primary outcome measure

  • Quality of life at home [ Time Frame: Day 180 ]
  • Quality of life at home [ Time Frame: Day 180 ]

Central Contacts and Locations

Central contacts

Rongyu (Cindy) Jin

4163404800rongyu.jin@uhn.ca

Catherine Bellissimo, PhD

catherine.bellissimo@uhn.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2N2

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 21, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-05-21.