Diaphragmatic Ultrasound and Weaning After Lung Transplant.

NCT05670327 | Completed DMC

• 1 other identifier: LUS_BLT
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaphragm; Diaphragm Disease; Diaphragm Issues; Weakness, Muscle

Keywords

bilateral lung transplant; diaphragmatic dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Impact of TFdi on weaning

  through study completion, an average of 1 year

• Relevant clinical correlation (spearman correlation)

  through study completion, an average of 1 yea

• Relation between invasive mechanical ventilation (IMV) before the first weaning trial and TFdi

  through study completion, an average of 1 yea

Study Arms (1)

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

Interventions

Diaphragmatic ultrasound assessment OTHER

TFdi, diaphragmatic dysplacement, NAVA assessment, respiratory paramenters

Bilateral lung recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Bilateral lung transplant at the first graft.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Institute of Anaesthesia and Intensive Care, Padua University hospital

Padua, 35120, Italy

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: January 4, 2023
• Study Start: June 22, 2021
• Primary Completion: October 19, 2022
• Study Completion: December 1, 2022
• Last Updated: January 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)