Clinical Trial

The Hering-Breuer Reflex in Bilateral Lung Transplant Patients

Study acronym: HB-DLTX
Recruiting
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Record status
This record was last updated December 12, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07280611
Lead Sponsor Policlinico Hospital
Conditions Hering-Breuer Reflex
Enrollment 22 participants
Start Date 2025-10-07
Primary Completion 2026-01 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-12-12