Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasogastric tube placement and elicitation of Hering-Breuer reflex | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 cmHâ‚‚O) in patients who underwent bilateral lung transplantation and in those who underwent non-thoracic surgery. | At the enrollment |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Recruiting | Milan | Michigan | 20122 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will be conducted on two groups of subjects:
Not provided
Not provided
Not provided
Not provided
|