Status:
UNKNOWN
Physiological Response in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist
Lead Sponsor:
Policlinico Hospital
Collaborating Sponsors:
University of Lausanne Hospitals
Conditions:
Work of Breathing
Lung Transplant; Complications
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Primary Graft Dysfunction (PGD) respresents the leading cause of mortality in early post-operative period of Lung Tranplantation (LTx). Protective ventilatory strategy could potentially reduce the ris...
Detailed Description
Lung transplantation (LTx) is an important treatment option for select patients with end-stage pulmonary disease. Primary Graft Dysfunction (PGD) is the main cause of death; in the early period follow...
Eligibility Criteria
Inclusion
- Age \> 18 y.o.
- Admission to ICU for post-operative monitoring after LTx
- Presence of spontaneous breathing activity
- Sedation titrated to a target RASS between 0 and -2
- Written informed consent obtained
Exclusion
- Contraindication to nasogastric tube insertion (gastroesophageal surgery in the previous 3 months, gastroesophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma)
- Increased risk of bleeding with nasogastric tube insertion, due to severe coagulation disorders and severe thrombocytopenia ( i.e., INR \> 2 and platelets count \< 70.000/mm3)
- Severe hemodynamic instability (noradenaline \> 0.3 μg/kg/min and/or use of vasopressin)
- Postoperative extracorporeal respiratory support (ECMO)
- Pre-operative reconditioning of the transplanted lungs by means of ex-vivo lung perfusion (EVLP)
- Lung retransplantation
- Failure to obtain a stable EAdi signal
Key Trial Info
Start Date :
November 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03367221
Start Date
November 23 2017
End Date
November 1 2019
Last Update
December 8 2017
Active Locations (2)
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1
Ospedale Maggiore Policlinico
Milan, Italy, 20122
2
University Hospital of Lausanne
Lausanne, Switzerland, 10111