Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Michigan, 20122, Italy
Location status: Recruiting
NCT Number: NCT07280611
The goal of this clinical trial (non-pharmacologic, single-center) is to determine whether the Hering-Breuer inflation reflex is preserved-and how it is modulated by end-expiratory pressure-in adult intensive-care patients who have undergone bilateral lung transplantation.
The study will enroll men and women ≥ 18 years admitted to the ICU during the early weaning phase and will include a comparison group of intubated ICU patients after major non-thoracic surgery.
The main questions it aims to answer are:
* Is the Hering-Breuer reflex (measured as the ratio THBR/TSPONT) absent or attenuated in double-lung-transplant recipients? * Does changing the level of positive end-expiratory pressure (PEEP 8 vs 12 cmH₂O) influence the reflex?
Comparison group: Researchers will compare the transplant arm (post-bilateral lung transplantation) with the control arm (post-operative, non-thoracic surgery patients) to see whether loss or blunting of the reflex-and its response to PEEP-differs between the two cohorts.
Participants will:
* Have a nasogastric catheter with embedded electrodes positioned to record the electrical activity of the diaphragm (EAdi). * Be ventilated in pressure-support mode at two preset PEEP levels (8 cmH₂O and 12 cmH₂O) during the weaning phase. * Receive one standardized high-volume insufflation at ~30 cmH₂O in each PEEP condition to elicit the reflex, while EAdi, airway pressures, inspiratory/expiratory times, and tidal volumes are recorded for 10 minutes per level.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Milan, Michigan, 20122, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For group 1, patients meeting at least one of the following criteria will be excluded:
For group 2, patients presenting with one or more of the following criteria will be excluded:
Enrolled patients will have a nasogastric tube placed, through which diaphragmatic electrical activity will be measured. Patients will be ventilated in pressure support mode with an expansion breath delivered at a maximum pressure of approximately 30 cmH2O in order to elicit the Hering-Breuer Reflex. Diaphragmatic electrical activity, timing, volumes and pressures will then be analyzed before and after the expansion breath over a 10 minute period, testing two levels of PEEP (8 and 12 cmH2O).
Time frame: At the enrollment
Comparison of the ratio between the diaphragm electrical activation time after a high-volume breath aimed at eliciting the HBR (THBR) and a spontaneous breath (TSPONT), i.e., the THBR/TSPONT ratio, between patients who underwent bilateral lung transplantation and those who underwent non-thoracic surgery.
Time frame: At the enrollment
Variation of the THBR/TSPONT ratio calculated at two different PEEP levels (8 and 12 cmH₂O) in patients who underwent bilateral lung transplantation and in those who underwent non-thoracic surgery.
Policlinico Hospital
Other
Acronym: HB-DLTX
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.