Clinical trial NCT05670327: Diaphragmatic Ultrasound and Weaning After Lung Transplant.
Official title: Diaphragmatic Dysfunction Predicts Difficult Weaning From Mechanical Ventilation After Bilateral Lung Transplantation: a Prospective Clinical Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaphragm
Diaphragm Disease
Diaphragm Issues
Weakness, Muscle
Keywords: bilateral lung transplant
diaphragmatic dysfunction
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bilateral lung transplant at the first graft.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diaphragmatic dysfunction at ultrasound assessment
timeFrame: through study completion, an average of 1 yea
Secondary outcomes:
measure: Impact of TFdi on weaning
timeFrame: through study completion, an average of 1 year
measure: Relevant clinical correlation (spearman correlation)
timeFrame: through study completion, an average of 1 yea
measure: Relation between invasive mechanical ventilation (IMV) before the first weaning trial and TFdi
timeFrame: through study completion, an average of 1 yea
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Institute of Anaesthesia and Intensive Care, Padua University hospital
Study officials:
References: