Diaphragmatic Ultrasound and Weaning After Lung Transplant.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-22

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diaphragm Diaphragm Disease Diaphragm Issues Weakness, Muscle

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Diaphragmatic ultrasound assessment

Intervention Type OTHER

TFdi, diaphragmatic dysplacement, NAVA assessment, respiratory paramenters

Interventions

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Diaphragmatic ultrasound assessment

TFdi, diaphragmatic dysplacement, NAVA assessment, respiratory paramenters

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No