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Completed

NCT Number: NCT05670327

Diaphragmatic Ultrasound and Weaning After Lung Transplant.

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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Key information

Conditions

Diaphragm Diaphragm Disease Diaphragm Issues Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weakness, Muscle

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Anaesthesia and Intensive Care, Padua University hospital

Padova, 35120, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diaphragmatic ultrasound assessment

Other

TFdi, diaphragmatic dysplacement, NAVA assessment, respiratory paramenters

Primary outcomes

  1. Diaphragmatic dysfunction at ultrasound assessment

    Time frame: 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 outcomes

  1. Impact of TFdi on weaning

    Time frame: 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)

    Time frame: 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

    Time frame: through study completion, an average of 1 yea

    nonlinear correlation between IMV and TFdi

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 4, 2023
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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