Diaphragm, Diaphragm Disease, Diaphragm Issues, Weakness, Muscle
Conditions
Keywords
bilateral lung transplant, diaphragmatic dysfunction
Brief summary
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
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.
Interventions
OTHERDiaphragmatic ultrasound assessment
TFdi, diaphragmatic dysplacement, NAVA assessment, respiratory paramenters
Sponsors
University of Padova
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diaphragmatic dysfunction at ultrasound assessment | through study completion, an average of 1 yea | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of TFdi on weaning | through study completion, an average of 1 year | the impact of DD, assessed using TFdi, on weaning (defined simple, difficult or prolonged according to pre-defined criteria). |
| Relevant clinical correlation (spearman correlation) | through study completion, an average of 1 yea | Searman correlation between TFdi and neuroventilatory efficiency (NVE) and between TFdi and rapid shallow breathing index (RSBI) |
| Relation between invasive mechanical ventilation (IMV) before the first weaning trial and TFdi | through study completion, an average of 1 yea | nonlinear correlation between IMV and TFdi |
Countries
Italy
Outcome results
None listed