|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03367221 |
|
Date of registration:
|
24/11/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Physiological Response in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist
TRANS-NAVA |
|
Scientific title:
|
Physiological Response to Different Levels of Support in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist (NAVA) |
|
Date of first enrolment:
|
November 23, 2017 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT03367221 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Italy
|
Switzerland
| | | | | | |
|
Contacts
|
|
Name:
|
Nadia Corcione, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Fondazione IRCCS Ca' Granda |
|
|
Name:
|
Alberto Zanella, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Milan |
|
|
Name:
|
Giacomo Grasselli, Prof |
|
Address:
|
|
|
Telephone:
|
0255033258 |
|
Email:
|
giacomo.grasselli@unimi.it |
|
Affiliation:
|
|
|
|
Name:
|
Chiara Abbruzzese, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
|
|
Name:
|
Antonio Pesenti, Prof |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Milan |
|
|
Name:
|
Luigi Castagna, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
|
|
Name:
|
Nicola Bottino, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Age > 18 y.o.
- Admission to ICU for post-operative monitoring after LTx
- Presence of spontaneous breathing activity
- Sedation titrated to a target RASS between 0 and -2
- Written informed consent obtained
Exclusion Criteria:
- Contraindication to nasogastric tube insertion (gastroesophageal surgery in the
previous 3 months, gastroesophageal bleeding in the previous 30 days, history of
esophageal varices, facial trauma)
- Increased risk of bleeding with nasogastric tube insertion, due to severe coagulation
disorders and severe thrombocytopenia ( i.e., INR > 2 and platelets count <
70.000/mm3)
- Severe hemodynamic instability (noradenaline > 0.3 µg/kg/min and/or use of
vasopressin)
- Postoperative extracorporeal respiratory support (ECMO)
- Pre-operative reconditioning of the transplanted lungs by means of ex-vivo lung
perfusion (EVLP)
- Lung retransplantation
- Failure to obtain a stable EAdi signal
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Lung Transplant; Complications
|
|
Ventilator-Induced Lung Injury
|
|
Neurally Adjusted Ventilatory Assist
|
|
Work of Breathing
|
|
Intervention(s)
|
|
Device: NAVA ventilation
|
|
Primary Outcome(s)
|
|
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)
[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
[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
[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
[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
[Time Frame: One hour after the recovery of spontaneous breathing]
|
|
Secondary Outcome(s)
|
|
Ultrasound assessment of the changes of Diaphragm's Thickening Fraction at different levels of Positive End Expiratory Pressure and at different NAVA gains
[Time Frame: One hour after the recovery of spontaneous breathing]
|
|
Evaluation of the feasibility of Plateau Pressure during NAVA
[Time Frame: One hour after the recovery of spontaneous breathing, with inspiratory hold manoeuvres]
|
|
Assesment of the total asynchrony index (double triggering + missed efforts + inspiratory trigger delay +short cycling + prolonged cycling)
[Time Frame: One hour after the recovery of spontaneous breathing]
|
|
Secondary ID(s)
|
|
TRANS-NAVA
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|