DiaphragmNCT05670327
Diaphragmatic Ultrasound and Weaning After Lung Transplant.
An observational study of Diaphragm and Diaphragm Disease, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm, Diaphragm Disease, Diaphragm Issues
- What is being tested?
- Diaphragmatic ultrasound assessment
- How many people
- 43 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jun 2021to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bilateral lung transplant at the first graft.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Anaesthesia and Intensive Care, Padua University hospital
Padova, 35120
About this study
Official title: 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.
Read the 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.
- Conditions
- Diaphragm, Diaphragm Disease, Diaphragm Issues, Weakness, Muscle
- Being tested
- Diaphragmatic ultrasound assessment
- Keywords
- bilateral lung transplant, diaphragmatic dysfunction
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic ultrasound assessmentOther
TFdi, diaphragmatic dysplacement, NAVA assessment, respiratory paramenters
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Diaphragmatic ultrasound assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 yea
Secondary outcomes (3)
Impact of TFdi on weaning
the impact of DD, assessed using TFdi, on weaning (defined simple, difficult or prolonged according to pre-defined criteria).
Measured: 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)
Measured: 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
Measured: through study completion, an average of 1 yea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start22 Jun 2021
- Primary completion19 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiaphragmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annalisa Boscolo, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670327
- Sponsor's protocol ID
- LUS_BLT
- Status last verified
- Dec 2022
- First submitted
- 28 Aug 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Dysfunction Predicts Difficult Weaning From Mechanical Ventilation After Bilateral Lung Transplantation: a Prospective Clinical Study.
- ClinicalTrials.gov ID
- NCT05670327
- Acronym / sponsor ID
- LUS_BLT
- Conditions
- Diaphragm, Diaphragm Disease, Diaphragm Issues, Weakness, Muscle
- Keywords
- bilateral lung transplant, diaphragmatic dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral lung recipients | – | Other: Diaphragmatic ultrasound assessmentAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bilateral lung transplant at the first graft.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic ultrasound assessmentTFdi, diaphragmatic dysplacement, NAVA assessment, respiratory paramenters | Other | Bilateral lung recipients |
Primary outcome
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
3 secondary outcomes
Impact of TFdi on weaning
Time frame: through study completion, an average of 1 year
Relevant clinical correlation (spearman correlation)
Time frame: through study completion, an average of 1 yea
Relation between invasive mechanical ventilation (IMV) before the first weaning trial and TFdi
Time frame: through study completion, an average of 1 yea
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragm and Diaphragm Disease, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic dysfunction at ultrasound assessment (time frame: through study completion, an average of 1 yea). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.