Actively Recruiting
The Hering-Breuer Reflex in Bilateral Lung Transplant Patients
Led by Policlinico Hospital · Updated on 2025-12-12
22
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Hering-Breuer Reflex in Bilateral Lung Transplant Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Both sexes
- For group 1: admitted to the Intensive Care Unit after bilateral lung transplantation during respiratory weaning
- For group 2: admitted to the Intensive Care Unit intubated after non-thoracic surgery for support or monitoring
You will not qualify if you...
- For group 1: re-transplantation or single-lung transplantation
- For group 1: urgent lung transplantation
- For group 1: post-transplant respiratory system compliance less than 30 mL/cmH2O
- For group 1: hemodynamic instability (plasma lactate > 4 mmol/L, need for vasoactive support with norepinephrine or epinephrine > 0.05 mcg/kg/min, or systolic arterial pressure < 80 mmHg)
- For group 1: increased bleeding risk due to coagulopathy or severe thrombocytopenia (INR > 2 and platelets < 70,000)
- For group 1: pregnancy
- For group 2: postoperative respiratory system compliance less than 30 mL/cmH2O
- For group 2: hemodynamic instability as defined above
- For group 2: contraindications to nasogastric tube placement (recent gastroesophageal surgery, recent gastroesophageal bleeding, esophageal varices, facial trauma)
- For group 2: increased bleeding risk due to coagulopathy or severe thrombocytopenia
- For group 2: history of lung transplantation or major thoracic surgery
- For group 2: pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Michigan, Italy, 20122
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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