Diaphragmatic Ultrasound and Weaning After Lung Transplant.

• Sponsor: University of Padova (Other)
• Overall Status: Completed
• CT.gov ID: NCT05670327
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Actual Duration (Months): 17.3
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diaphragm; Diaphragm Disease; Diaphragm Issues; Weakness, Muscle	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 Design

• Study Type: Observational
• Actual Enrollment: 43 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Diaphragmatic Dysfunction Predicts Difficult Weaning From Mechanical Ventilation After Bilateral Lung Transplantation: a Prospective Clinical Study.
• Actual Study Start Date: Jun 22, 2021
• Actual Primary Completion Date: Oct 19, 2022
• Actual Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. 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)

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Anaesthesia and Intensive Care, Padua University hospital	Padova		Italy	35120

Sponsors and Collaborators

• University of Padova

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Annalisa Boscolo, Principal investigator, University of Padova
• ClinicalTrials.gov Identifier: NCT05670327
• Other Study ID Numbers: LUS_BLT
• First Posted: Jan 4, 2023
• Last Update Posted: Jan 4, 2023
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Annalisa Boscolo, Principal investigator, University of Padova: bilateral lung transplant; diaphragmatic dysfunction
• Additional relevant MeSH terms: Muscle Weakness

Study Results

No Results Posted as of Jan 4, 2023