Status:
ACTIVE_NOT_RECRUITING
DIAPHRAGM STRENGTH AND LUNG VOLUMES
Lead Sponsor:
Unity Health Toronto
Conditions:
Mechanical Ventilation
Eligibility:
All Genders
18+ years
Brief 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 prolon...
Detailed Description
Our ultimate objective is to create a correction factor for adjusting values of diaphragm strength obtained from measurements of pressure generated by PNS performed at various EELV induced by differen...
Eligibility Criteria
Inclusion
- Inclusion criteria for the healthy participants will be age ≥18 years, no acute or chronic condition impacting respiratory, musculoskeletal or neurological system or that would interfere with the performance of the tests; body mass index \<35 kg/m2 and sufficient English fluency to provide informed consent and to follow the study protocols.
- Inclusion criteria for patients will be intubation for more than 6 hours, triggering or not the ventilator (any mode of ventilation).
Exclusion
- Exclusion criteria for the healthy participants will be contraindication for PNS (e.g., cardiac pacemaker or implanted defibrillator, cervical implants), contraindication for a nasogastric tube (e.g., esophageal varices, recent nasal bleeding)and pregnancy.
- Exclusion criteria for patients will be primary contraindication for magnetic PNS, severe neurological disorders, pregnancy, current use of continuous neuromuscular blocking agents at the time of the study procedure, P/F ratio \<120, unstable hemodynamics (2 vasopressors), monitored ICP.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07206459
Start Date
December 1 2024
End Date
December 1 2026
Last Update
October 3 2025
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada