Diaphragmatic Ultrasound and Weaning After Lung Transplant.

Weakness, Muscle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05670327
• Other study ID #: LUS_BLT
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Diaphragm
• Diaphragm Disease
• Diaphragm Issues
• Muscle Weakness
• Weakness, Muscle

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