Hering-Breuer ReflexHB-DLTXNCT07280611
The Hering-Breuer Reflex in Bilateral Lung Transplant Patients
A study testing Nasogastric tube placement and elicitation of Hering-Breuer reflex in people with Hering-Breuer Reflex, run by Policlinico Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hering-Breuer Reflex
- What is being tested?
- Nasogastric tube placement and elicitation of Hering-Breuer reflex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 7 Oct 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years;
- Both sexes;
- For group 1: patients admitted to the Intensive Care Unit after undergoing bilateral lung transplantation, during respiratory weaning;
- For group 2: patients admitted to the Intensive Care Unit for support or monitoring after non-thoracic surgery, who will arrive intubated.
Who cannot join
- For group 1, patients meeting at least one of the following criteria will be excluded:
- Re-transplantation or single-lung transplantation;
- Urgent lung transplantation;
- Post-transplant respiratory system compliance < 30 mL/cmH₂O;
- Hemodynamic instability (defined as the presence of one or more of the following: plasma lactate > 4 mmol/L, need for vasoactive support with norepinephrine and/or epinephrine at a dose > 0.05 mcg/kg/min, systolic arterial pressure < 80 mmHg);
- Increased risk of bleeding related to the placement of a nasogastric tube due to coagulopathy or severe thrombocytopenia (INR > 2 and platelets < 70,000);
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- Pregnancy
- For group 2, patients presenting with one or more of the following criteria will be excluded:
- Postoperative respiratory system compliance < 30 mL/cmH₂O;
- Hemodynamic instability (defined as the presence of one or more of the following: plasma lactate > 4 mmol/L, need for vasoactive support with norepinephrine and/or epinephrine at a dose > 0.05 mcg/kg/min, systolic arterial pressure < 80 mmHg);
- Contraindications to nasogastric tube placement (gastroesophageal surgery within the last 3 months, gastroesophageal bleeding in the previous 30 days, esophageal varices, facial trauma);
- Increased risk of bleeding related to the placement of a nasogastric tube due to coagulopathy or severe thrombocytopenia (INR > 2 and platelets < 70,000);
- History of lung transplantation or major thoracic surgery;
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Michigan, 20122
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, +39 0255033285, alessio.caccioppola@policlinico.mi.it
About this study
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.
Read more
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
- Hering-Breuer Reflex
- Being tested
- Nasogastric tube placement and elicitation of Hering-Breuer reflex
- Keywords
- Hering-Breuer reflex, Bilateral Lung Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasogastric tube placement and elicitation of Hering-Breuer reflexDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Lung Transplant patients | Experimental | 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. Receives: Device: Nasogastric tube placement and elicitation of Hering-Breuer reflex |
| Non-thoracic surgery patients | Active comparator | 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. Receives: Device: Nasogastric tube placement and elicitation of Hering-Breuer reflex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the enrollment
Secondary outcomes (1)
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.
Measured: At the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start7 Oct 2025
- Primary completionJan 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hering-Breuer ReflexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted on two groups of subjects: * Patients admitted to the Intensive Care Unit for post-operative care following bilateral lung transplantation (Group 1); * Patients admitted to the Intensive Care Unit for post-operative care or monitoring after non-thoracic surgery (Group 2 - control group)
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Grasselli, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280611
- Sponsor's protocol ID
- ID 5483
- Acronym
- HB-DLTX
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hering-Breuer Reflex in Bilateral Lung Transplant Patients
- ClinicalTrials.gov ID
- NCT07280611
- Acronym / sponsor ID
- HB-DLTX / ID 5483
- Conditions
- Hering-Breuer Reflex
- Keywords
- Hering-Breuer reflex, Bilateral Lung Transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be conducted on two groups of subjects: * Patients admitted to the Intensive Care Unit for post-operative care following bilateral lung transplantation (Group 1); * Patients admitted to the Intensive Care Unit for post-operative care or monitoring after non-thoracic surgery (Group 2 - control group)
| Arm | Type | Receives |
|---|---|---|
| Bilateral Lung Transplant patients | Experimental | Device: Nasogastric tube placement and elicitation of Hering-Breuer reflexThis 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. |
| Non-thoracic surgery patients | Active comparator | Device: Nasogastric tube placement and elicitation of Hering-Breuer reflexThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years;
- Both sexes;
- For group 1: patients admitted to the Intensive Care Unit after undergoing bilateral lung transplantation, during respiratory weaning;
- For group 2: patients admitted to the Intensive Care Unit for support or monitoring after non-thoracic surgery, who will arrive intubated.
Key exclusion criteria (14 listed)
- Re-transplantation or single-lung transplantation;
- Urgent lung transplantation;
- Post-transplant respiratory system compliance < 30 mL/cmH₂O;
- Hemodynamic instability (defined as the presence of one or more of the following: plasma lactate > 4 mmol/L, need for vasoactive support with norepinephrine and/or epinephrine at a dose > 0.05 mcg/kg/min, systolic arterial pressure < 80 mmHg);
- Increased risk of bleeding related to the placement of a nasogastric tube due to coagulopathy or severe thrombocytopenia (INR > 2 and platelets < 70,000);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasogastric tube placement and elicitation of Hering-Breuer reflexEnrolled 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). | Device | Bilateral Lung Transplant patients, Non-thoracic surgery patients |
Primary outcome
THBR/TSPONT ratio
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.
1 secondary outcome
The variation of the THBR/TSPONT ratio as a function of PEEP
Time frame: At the enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasogastric tube placement and elicitation of Hering-Breuer reflex in people with Hering-Breuer Reflex, run by Policlinico Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
THBR/TSPONT ratio (time frame: At the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.