Lung transplant Patients' breathing reflex under scrutiny

NCT ID NCT07280611

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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a natural breathing reflex, called the Hering-Breuer reflex, still works in people who have received a double lung transplant. Researchers will place a thin tube through the nose to measure diaphragm activity while patients are on a ventilator. They will compare 11 transplant patients with 11 other ICU patients who had non-chest surgery to see if the reflex is weakened and how it changes with different ventilator pressure settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors better understand how lung transplants affect breathing control, potentially improving ventilator settings for these patients.
What could go wrong
This is a very small, early observational study with only 22 participants. It does not test a treatment, so it cannot directly lead to new therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: 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); * 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.

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Contacts and locations

Locations

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, Michigan, 20122, Italy