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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05670327
Other study ID # LUS_BLT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 22, 2021
Est. completion date December 1, 2022

Study information

Verified date December 2022
Source University of Padova
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date December 1, 2022
Est. primary completion date October 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
Diaphragmatic ultrasound assessment
TFdi, diaphragmatic dysplacement, NAVA assessment, respiratory paramenters

Locations

Country Name City State
Italy Institute of Anaesthesia and Intensive Care, Padua University hospital Padova

Sponsors (1)

Lead Sponsor Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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