Work of BreathingTRANS-NAVANCT03367221
Physiological Response in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist
A study testing NAVA ventilation in people with Work of Breathing and Lung Transplant; Complications, run by Policlinico Hospital at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Work of Breathing, Lung Transplant; Complications, Neurally Adjusted Ventilatory Assist
- What is being tested?
- NAVA ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Nov 2017to Nov 2019
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Recruiting
Ospedale Maggiore Policlinico
Milan, 20122
Giacomo Grasselli, Prof, 0255033258, giacomo.grasselli@unimi.it
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Lausanne
Lausanne, 10111
Lise Piquilloud, MD, +41 21 314 1632, Lise.Piquilloud@chuv.ch
About this study
Official title: Physiological Response to Different Levels of Support in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist (NAVA)
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.
Read the detailed description
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
- Conditions
- Work of Breathing, Lung Transplant; Complications, Neurally Adjusted Ventilatory Assist, Ventilator-Induced Lung Injury
- Being tested
- NAVA ventilation
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVA ventilationDevice
Assisted Ventilation Mode, synchronized, through EAdi catheter, with patient's inspiratory effort and proportional to respiratory drive
| Study group | Role | What they receive |
|---|---|---|
| NAVA group | Experimental | NAVA ventilation Receives: Device: NAVA ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: One hour after the recovery of spontaneous breathing
Secondary outcomes (3)
Evaluation of the feasibility of Plateau Pressure during NAVA
Plateau Pressure (Pplat)
Measured: 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)
Measured: 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
Measured: One hour after the recovery of spontaneous breathing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start23 Nov 2017
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Work of BreathingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Principal investigator, Giacomo Grasselli, Policlinico Hospital
- Investigators
- Chiara Abbruzzese, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoLuigi Castagna, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoNicola Bottino, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoAlberto Zanella, MD, Principal investigator, University of MilanNadia Corcione, MD, Principal investigator, Fondazione IRCCS Ca' GrandaAntonio Pesenti, Prof, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367221
- Sponsor's protocol ID
- TRANS-NAVA
- Acronym
- TRANS-NAVA
- Status last verified
- Dec 2017
- First submitted
- 24 Nov 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grasselli G, Castagna L, Abbruzzese C, Corcione N, Bottino N, Guzzardella A, Colombo SM, Carlesso E, Mauri T, Rossetti V, Palleschi A, Scaravilli V, Zanella A, Pesenti A. Pulmonary volume-feedback and ventilatory pattern after bilateral lung transplantation using neurally adjusted ventilatory assist ventilation. Br J Anaesth. 2021 Jul;127(1):143-152. doi: 10.1016/j.bja.2021.03.010. Epub 2021 Apr 21.
PubMed 33892948
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Response to Different Levels of Support in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist (NAVA)
- ClinicalTrials.gov ID
- NCT03367221
- Acronym / sponsor ID
- TRANS-NAVA / TRANS-NAVA
- Conditions
- Work of Breathing, Lung Transplant; Complications, Neurally Adjusted Ventilatory Assist, Ventilator-Induced Lung Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 8 Dec 2017 (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.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NAVA group | Experimental | Device: NAVA ventilationNAVA ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| NAVA ventilationAssisted Ventilation Mode, synchronized, through EAdi catheter, with patient's inspiratory effort and proportional to respiratory drive | Device | NAVA group |
Primary outcome
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
Electrical Activity of the Diaphragm (EAdi) (microVolt)
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
Neuro-Mechanical Coupling (NMC) (microvolt/cmH2O)
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
Neuro-Ventilatory Efficiency (NVE) (microvolt/mL)
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
Tidal Volume (mL)
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
Respiratory rate (Breaths/min)
3 secondary outcomes
Evaluation of the feasibility of Plateau Pressure during NAVA
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
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)
Time frame: One hour after the recovery of spontaneous breathing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- Derived from this study: PubMed 33892948Grasselli G, Castagna L, Abbruzzese C, Corcione N, Bottino N, Guzzardella A, Colombo SM, Carlesso E, Mauri T, Rossetti V, Palleschi A, Scaravilli V, Zanella A, Pesenti A. Pulmonary volume-feedback and ventilatory pattern after bilateral lung transplantation using neurally adjusted ventilatory assist ventilation. Br J Anaesth. 2021 Jul;127(1):143-152. doi: 10.1016/j.bja.2021.03.010. Epub 2021 Apr 21.
- Individual participant dataSharing planned: Undecided
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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.
Chiara Abbruzzese, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Luigi Castagna, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Nicola Bottino, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVA ventilation in people with Work of Breathing and Lung Transplant; Complications, run by Policlinico Hospital at 2 sites in 2 countries.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giacomo Grasselli, Prof (0255033258, giacomo.grasselli@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03367221, which also lists 1 linked publication.
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 8 Dec 2017.