Diaphragmatic Dysfunction Predicts Difficult Weaning From Mechanical Ventilation After Bilateral Lung Transplantation: a Prospective Clinical Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Diaphragmatic dysfunction at ultrasound assessment
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Diaphragmatic dysfunction at ultrasound assessment
Time Frame: 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 Outcomes
- Relevant clinical correlation (spearman correlation)(through study completion, an average of 1 yea)
- Impact of TFdi on weaning(through study completion, an average of 1 year)
- Relation between invasive mechanical ventilation (IMV) before the first weaning trial and TFdi(through study completion, an average of 1 yea)
Investigators
Annalisa Boscolo
Principal investigator
University of Padova