Diaphragmatic Ultrasound and Weaning After Lung Transplant.

Study Overview
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Brief Summary
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The prevalence and adverse effect of diaphragm dysfunction (DD) after bilateral-lung transplant (LT) are still unclear, despite a well-known negative impact on weaning and outcome in other cohorts of critically ill and surgical patients. Objects: The primary aim is investigating the prevalence of DD, assessed using point-of-care ultrasound and defined as diaphragm thickening fraction (TFdi) < 29%, at the first weaning trial after LT. Secondary aims are investigating the impact of DD on weaning (defined success or failure according to pre-defined criteria, neuroventilatory efficiency (EAdi or NVE), perioperative (14-day) pneumonia, ICU length of stay (LOS), in-hospital mortality, and identifying potential risk factors for DD. Moreover, we aim to study the correlation between TFdi versus EAdi/NVE and the rapid shallow breathing index (RSBI), respectively.

Detailed Description
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This is a prospective observational cohort study, approved by the Institutional Ethical Committee of Padua (reference number AOP2722). Written informed consent was obtained from each patient during the preoperative visit. All consecutive LT patients admitted to the Intensive Care Unit of the University Hospital of Padua were screened. Adult patients undergoing bilateral LT, not requiring invasive mechanical ventilation before surgery, were eligible for inclusion in the study only when they met the predefined 'readiness-to-wean' criteria on daily screening and were therefore deemed ready to undergone a first 30-min weaning trial. Exclusion criteria were: presence of neuromuscular blockers in the previous 12 hours, lack of ultrasound acoustic window, decline to participate, right hemi-diaphragmatic palsy due to surgical sacrifice of right phrenic nerve, duplicated patients.

Official Title
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Diaphragmatic Dysfunction Predicts Difficult Weaning From Mechanical Ventilation After Bilateral Lung Transplantation: a Prospective Clinical Study.

Conditions
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Diaphragm, Diaphragm Disease, Diaphragm Issues, Weakness, Muscle

Intervention / Treatment
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* Other: Diaphragmatic ultrasound assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients bilateral LT absent invasive mechanical ventilation before surgery fullfilling 'readiness-to-wean' criteria on daily screening (and therefore deemed ready to undergone a first 30-min weaning trial) Exclusion Criteria: presence of neuromuscular blockers in the previous 12 hours lack of ultrasound acoustic window decline to participate right hemi-diaphragmatic palsy due to surgical sacrifice of right phrenic nerve duplicated patients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bilateral lung recipients<br>Adult patients undergoing bilateral LT, not requiring invasive mechanical ventilation before surgery, were eligible for inclusion in the study only when they met the predefined 'readiness-to-wean' criteria on daily screening and were therefore deemed ready to undergone a first 30-min weaning trial. | Other: Diaphragmatic ultrasound assessment<br>* TFdi, diaphragmatic dysplacement, NAVA assessment, respiratory paramenters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragmatic dysfunction at ultrasound assessment | Prevalence of DD, assessed using point-of-care ultrasound and defined as diaphragm thickening fraction (TFdi) < 29% at the first weaning trial after lung transplant | through study completion, an average of 1 yea | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of TFdi on weaning | the impact of DD, assessed using TFdi, on weaning (defined simple, difficult or prolonged according to pre-defined criteria). | through study completion, an average of 1 year | 
| Relevant clinical correlation (spearman correlation) | Searman correlation between TFdi and neuroventilatory efficiency (NVE) and between TFdi and rapid shallow breathing index (RSBI) | through study completion, an average of 1 yea | 
| Relation between invasive mechanical ventilation (IMV) before the first weaning trial and TFdi | nonlinear correlation between IMV and TFdi | through study completion, an average of 1 yea | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bilateral lung transplant, diaphragmatic dysfunction