An interventional study of Nasogastric tube placement and elicitation of Hering-Breuer reflex in Hering-Breuer Reflex, sponsored by Policlinico Hospital. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Policlinico Hospital · Not applicable, Interventional, and Basic science
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:
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:
Policlinico Hospital is the lead sponsor of 65 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group include patients admitted to the Intensive Care Unit for post-operative care following bilateral lung transplantation during the weaning phase from mechanical ventilation. The following patients will be excluded: minors, those undergoing retransplantation, single-lung transplantation or urgent lung transplantation; patients with respiratory system compliance \< 30 mL/cmH2O; haemodynamically unstable patients and those at increased risk of bleeding due to nasogastric tube placement.
Device: Nasogastric tube placement and elicitation of Hering-Breuer reflex
This group include patients admitted to the Intensive Care Unit for post-operative care or monitoring after non-thoracic surgery. The following patients will be excluded: minors, those who had undergone previous lung transplant or thoracic surgery; patients with respiratory system compliance \< 30 mL/cmH2O; haemodynamically unstable patients; those at increased risk of bleeding due to nasogastric tube placement and patients with contraindications to nasogastric tube placement.
Device: Nasogastric tube placement and elicitation of Hering-Breuer reflex
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).
THBR/TSPONT ratio
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
The variation of the THBR/TSPONT ratio as a function of PEEP
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.
Time frame: At the enrollment
Plan to share: Yes
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