An interventional study of NAVA ventilation in Work of Breathing, Lung Transplant; Complications and Neurally Adjusted Ventilatory Assist, sponsored by Policlinico Hospital. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-08.
Sponsored by Policlinico Hospital · Not applicable, Interventional, and Treatment
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Among 12 studies in Ventilator-Induced Lung Injury with a site in Italy — 3 open to participants now, 3 under way, none of them phase 3. Ventilator-Induced Lung Injury · Italy.
Among the 12 studies in Ventilator-Induced Lung Injury with a site in Italy, this one is the only one that started in 2017, is one of 6 with no phase, and was the 3rd registered.
121 studies on the registry are indexed under Ventilator-Induced Lung Injury; 39 are open to participants now.
Browse Ventilator-Induced Lung Injury studies →3 of the 12 studies in Ventilator-Induced Lung Injury with a site in Italy are open now. Recruiting first, the newest first:
University of Padova · Sites in Italy
Ages 18+
Children's Hospital Los Angeles · Sites in Italy, United States, Canada
Ages 1 mo–18 yrs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 22 Ventilator-Induced Lung Injury studies recruiting now, 15 (68%) set no upper age limit and 5 (23%) stop at 75 or younger; 5 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 40 across 75 interventional studies indexed under Ventilator-Induced Lung Injury.
Median enrollment 20 across the 7 interventional studies, 40 across the 5 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 12 has an industry lead sponsor. The 9 most frequent:
Policlinico Hospital is the lead sponsor of 65 studies on the registry; 4 are open to participants now.
Policlinico Hospital has 2 studies filed under Ventilator-Induced Lung Injury — fewer than ten, so there is no comparison to draw.
1 of the studies in Ventilator-Induced Lung Injury with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04068012Children's Hospital Los AngelesClinical Decision Support Tool in PARDS Pilot Study | 2027-07 |
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Among the 12 studies in Ventilator-Induced Lung Injury with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Primary Graft Dysfunction (PGD) respresents the leading cause of mortality in early post-operative period of Lung Tranplantation (LTx). Protective ventilatory strategy could potentially reduce the risk of PGD in these patients. Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode that could allow to adopt this strategy. Aim of the study is to assess the feasibility of NAVA in the early post-LTx phase and to describe the breathing pattern and the physiological relationship between neural respiratory drive and different levels of ventilatory assist, in the absence of pulmonary vagal afferent feedback.
Lung transplantation (LTx) is an important treatment option for select patients with end-stage pulmonary disease. Primary Graft Dysfunction (PGD) is the main cause of death; in the early period following LTx a protective ventilatory strategy (tidal volume - Vt of 6 mL/Kg + Positive End Expiratory Pressure) could potentially reduce the risk of PGD in these patients. Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode in which neural inspiratory activity is monitored through the continuous recording of electrical activity of the diaphragm (EAdi). Actually, Guidelines about the adoption of a protective ventilatory strategy in the early post-opeartive period are lacking.
NAVA, because of its intrinsic properties (proportionality between respiratory drive and level of assist, prevention of diaphragm atrophy), could allow to reach the afore mentioned ventilatory strategy. So, aim of the study, is the evaluation of patients' neural breathing pattern during NAVA, in early post-operative period of LTx
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NAVA ventilation
Device: NAVA ventilation
Assisted Ventilation Mode, synchronized, through EAdi catheter, with patient's inspiratory effort and proportional to respiratory drive
Evaluation of the variations of Electrical Activity of the Diaphragm in response to different levels of ventilatory assist at different degrees of lung inflation (different Positive End Expiratory Pressure values)
Electrical Activity of the Diaphragm (EAdi) (microVolt)
Time frame: One hour after the recovery of spontaneous breathing
Evaluation of the variations of Neuro-Mechanical Coupling (expressed as microVolt of EAdi /cmH2O of airway pressure Ratio) in response to different levels of ventilatory assist at different degrees of lung inflation
Neuro-Mechanical Coupling (NMC) (microvolt/cmH2O)
Time frame: One hour after the recovery of spontaneous breathing
Evaluation of the variations of Neuro-ventilatory Efficiency (expressed as microvolt of EAdi / mL of Tidal Volume Ratio) in response to different levels of ventilatory assist at different degree of lung inflation
Neuro-Ventilatory Efficiency (NVE) (microvolt/mL)
Time frame: One hour after the recovery of spontaneous breathing
Evaluation of the changes in the patient's neural breathing pattern (expressed as mL of Tidal Volume) at different levels of ventilatory assist
Tidal Volume (mL)
Time frame: One hour after the recovery of spontaneous breathing
Evaluation of the changes in the patient's neural breathing pattern (expressed as respiratory rate) at different levels of ventilatory assist
Respiratory rate (Breaths/min)
Time frame: One hour after the recovery of spontaneous breathing
Evaluation of the feasibility of Plateau Pressure during NAVA
Plateau Pressure (Pplat)
Time frame: One hour after the recovery of spontaneous breathing, with inspiratory hold manoeuvres
Ultrasound assessment of the changes of Diaphragm's Thickening Fraction at different levels of Positive End Expiratory Pressure and at different NAVA gains
Diaphragm's Thickening Fraction (TF)
Time frame: One hour after the recovery of spontaneous breathing
Assesment of the total asynchrony index (double triggering + missed efforts + inspiratory trigger delay +short cycling + prolonged cycling)
Total Asinchrony Index
Time frame: One hour after the recovery of spontaneous breathing
Plan to share: Undecided
Started Nov 2017 (actual). Primary completion is estimated for Nov 2019, 24 months after the start.
Of 40 interventional studies with no phase under Ventilator-Induced Lung Injury, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Ventilator-Induced Lung Injury →
Policlinico Hospital