Diaphragmatic Ultrasound and Weaning After Lung Transplant.

Completed

• Conditions: Diaphragm Issues; Weakness, Muscle; Diaphragm; Diaphragm Disease
• Interventions: Other: Diaphragmatic ultrasound assessment

• Registration Number: NCT05670327
• Lead Sponsor: University of Padova

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 Timeline

• Study Start: 2021-06-22
• Study First Submitted: 2022-08-28
• Primary Completion: 2022-10-19
• Status Verified: 2022-12
• Study Completion: 2022-12-01
• Study First Submitted QC: 2022-12-20
• Last Update Submitted: 2022-12-20
• Study First Posted: 2023-01-04
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bilateral lung recipients	Diaphragmatic ultrasound assessment	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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).
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

Trial Locations

Locations (1)

Institute of Anaesthesia and Intensive Care, Padua University hospital; 🇮🇹 Padova, Italy