Diaphragmatic Ultrasound and Weaning After Lung Transplant.

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

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.

Study Overview

• Status: Completed
• Conditions: Diaphragm Disease; Weakness, Muscle; Diaphragm Issues; Diaphragm
• Intervention / Treatment: Other: Diaphragmatic ultrasound assessment

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 Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35120
    • Institute of Anaesthesia and Intensive Care, Padua University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Bilateral lung transplant at the first graft.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bilateral lung recipients; 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.	Other: Diaphragmatic ultrasound assessment; TFdi, diaphragmatic dysplacement, NAVA assessment, respiratory paramenters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2021
• Primary Completion (Actual): October 19, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: August 28, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Estimate): January 4, 2023

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: bilateral lung transplant; diaphragmatic dysfunction
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: LUS_BLT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No