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ACTIVE NOT RECRUITING
NCT07206459

DIAPHRAGM STRENGTH AND LUNG VOLUMES

Sponsor: Unity Health Toronto

View on ClinicalTrials.gov

Summary

Diaphragm dysfunction (loss of diaphragm strength) is common in the intensive care unit (ICU) patients using ventilators. The diaphragm is the main muscle of respiration and its dysfunction can prolong mechanical ventilation and increase mortality risk. The ventilator settings determine how much air and pressure the patient gets every breath and how much air is left on the lungs after they breathe out. The amount of air left on the lungs influence diaphragm strength measurements which can affect clinical decisions, such as weaning patients off ventilators. This research aims to explore the relationship between the amount of air left in the lungs and diaphragm strength to create a method of correcting measurements of diaphragm strength according to how much air the patients have in the lungs after they breath out. The investigators will test healthy individuals to understand this relationship, then verify if it holds true for ventilated patients by comparing results from both groups.

Official title: Diaphragm Strength and Lung Volumes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2024-12-01

Completion Date

2026-12-01

Last Updated

2025-10-03

Healthy Volunteers

Yes

Interventions

OTHER

Healthy Patients

RESEARCH DESIGN AND METHODS This will be a physiological observational study Study design. Participants will breathe on CPAP with a ventilator. The investigators will deliver the PNS at PEEP levels of zero cmH2O (baseline EELV), zero cmH2O + an abdominal binder (to reduce lung volume), five cmH2O and ten cmH2O. The abdominal binder will be used to achieve an EELV lower than at baseline. At the end of the protocol another PNS at zero cmH2O (baseline EELV) will be performed. Healthy participants will be exposed to the different levels of PEEP from 2 to 5 minutes before each PNS is performed. At every PEEP level, relative changes in EELV (∆z) will be measured with Electrical Impedance Tomography (EIT) to record relative changes in EELV and the electrical activity of the costal diaphragm will be measured using surface electromyography

OTHER

Critically Care Patients

RESEARCH DESIGN AND METHODS This will be a physiological observational study Study design. For patients. The investigators will perform PNS at the patients own mode of ventilation at their clinical level of PEEP (baseline EELV), PEEP of zero cmH2O (if acceptable for 5 minutes), clinical PEEP ± 2 - 4 cmH2O. At the end of the protocol, another stimulation at the clinical level of PEEP (baseline EELV) will be performed. Patients will be exposed to the different levels of PEEP from 2 to 5 minutes before each PNS is performed.

Locations (1)

St. Michael's Hospital

Toronto, Ontario, Canada