Inspiratory Work of Breathing Before and After Extubation
INTEGRATION
INTEGRATION
Sponsor study identifier
observational
67
1 country
1
Study Start
September 1, 2020
Actual (reported)Primary Completion
June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Critically ill patients who (1) are not able to maintain their airway, (2) cannot breathe on their own, or (3) both, are ones who often require tracheal intubation and support from a breathing machine (mechanical ventilator). When the patient is ready to be liberated from the mechanical ventilator because the initial insult for intubation has been resolved, the patient is screened using the readiness to wean test in preparation for extubation. As the patient passes this screening, a spontaneous breathing test (SBT) is initiated. Currently, there are many debates surrounding which SBT technique is most favorable. At Toronto General Hospital, the clinical team uses a zero-end expiratory pressure (ZEEP) trial. Once the patient successfully passes their SBT they are then extubated. The patient will undergo a spontaneous breathing trial of continuous positive airway pressure (CPAP) of 5 cmH2O and ZEEP, in which time the investigators will be using a new technology called electrical impedance tomography (EIT), to study and compare the end expiratory lung volume (EELV); investigators will use an esophageal catheter to measure and monitor pressures in the lung, and also assess the patient's work of breathing. This will be repeated once the patient has been extubated safely.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2020
Actual (reported)May 23, 2025
Actual (reported)June 12, 2025
Actual (reported)June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in end-expiratory lung volume (EELV) between the varying conditions (CPAP 5, ZEEP, and post-extubation).
End-expiratory lung volume is assessed using Electrical Impedance Tomography (EIT) and expressed in milliliters (mL) across all three conditions: 1. CPAP 5 cm H₂O 2. ZEEP (Zero End-Expiratory Pressure) 3. Post-extubation
Up to 30 minutes after extubation
Discriminative ability of occlusion maneuvers to detect expiratory muscle effort
The ability of occlusion maneuvers to detect presence of expiratory muscle effort, measured with the gold standard (gastric pressure), will be assessed with receiver operating characteristic curves.
Up to 30 minutes after spontaneous breathing trial initiation
Eligible patients admitted to the medical surgical intensive care unit (MSICU) at Toronto General Hospital (TGH) requiring invasive mechanical ventilation, after obtaining consent. Inclusion will be stratified in a 1:1 ratio between lung transplant and non-transplant patients.
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G2C4, Canada
Ewan Goligher, MD
University Health Network, Toronto
First Submitted
May 23, 2025
First Posted
June 12, 2025
Study Start
September 1, 2020
Actual (reported)Primary Completion
June 2026
Estimated (date passed)4DX Functional Lung Imaging in the Diagnosis of Chronic Lung Allograft Dysfunction After Lung Transplantation
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 12, 2025
Record last verified: 2025-05
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