Work of BreathingNAVAMECHNCT05689476
Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA
A study testing NAVA GROUP in people with Work of Breathing and Lung Transplantation, run by University of Padova at 1 site in Italy.
Trial summary
Protective ventilatory strategy should be applied to reduce ventilator-induced lung injury (VILI) after Lung Transplantation (LTx) or in case of acute respiratory failure requiring invasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Work of Breathing, Lung Transplantation, Neurally Adjusted Ventilatory Assist
- What is being tested?
- NAVA GROUP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 27 Dec 2022to 27 Dec 2025
- Phase
- Interventional
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 or acute respiratory failure needing invasive mechanical ventilation
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Institute of Anaesthesia and Intensive Care, Padua University hospital
Padova, Italy, 35120
Annalisa Boscolo, MD, PhD, +393498324972, annalisa.boscolobozza@aopd.veneto.it
About this study
Official title: Evaluation of the Relationship Between Electrical Activity of the Diaphragm and Respiratory Mechanics During Neurally Adjusted Ventilatory Assist in Lung Transplant Patients and in Patients Affected by Acute Respiratory Failure.
Protective ventilatory strategy should be applied to reduce ventilator-induced lung injury (VILI) after Lung Transplantation (LTx) or in case of acute respiratory failure requiring invasive mechanical ventilation. Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode in which respiratory support is coordinated by the electrical activity of the diaphragm (EAdi). Aim of the study is to assess the physiological relationship between neural respiratory drive, as assessed by EAdi, and tidal volume, driving pressure, and mechanical power, at different levels of ventilatory assist, in the absence of pulmonary vagal afferent feedback or during acute respiratory failure. Additional parameters will be collected: Pmus, Pocc, transpulmonary pressure etc.
Read the detailed description
Lung transplantation (LTx) is an important treatment option for select patients with end-stage pulmonary disease, while acute respiratory failure is a common disease among ICU patients. In the early period, following LTx or at the beginning of acute respiratory failure, a protective ventilatory strategy should be applied to reduce ventilator-induced lung injury (VILI). 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) and then used to coordinate the respiratory support delivered by the ventilator.
NAVA, because of its intrinsic properties (proportionality between respiratory drive and level of assist, prevention of diaphragm atrophy), could allow the aforementioned ventilatory strategy, however it may require the integrity of the pulmonary vagal afferent feedback in order to avoid volutrauma. So, the aim of the study is the evaluation of the physiological relationship between EAdi and tidal volume, driving pressure and mechanical power, at different levels of ventilatory assist, in the absence of pulmonary vagal afferent feedback during early post-operative period after LTx and among critically ill patients affected by acute respiratory failure. Finally, additional parameters will be collected: Pmus, Pocc, transpulmonary pressure etc.
- Conditions
- Work of Breathing, Lung Transplantation, Neurally Adjusted Ventilatory Assist, Ventilator-Induced Lung Injury, Acute Respiratory Failure (ARF)
- Being tested
- NAVA GROUP
- Keywords
- Lung Injury, Ventilator-Induced Lung Injury, Neurally Adjusted Ventilatory Assist
- Medical subject headings
- Ventilator-Induced Lung Injury, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVA GROUPDevice
NAVA ventilation: 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 GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical Activity of the Diaphragm (EAdi)
Evaluation of the variations of tidal volume 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
Tidal Volume (mL) and Respiratory rate (Breaths/min)
Evaluation of the changes in the patient's neural breathing pattern (expressed as mL of Tidal Volume) at different levels of ventilatory assist. Also patient's respiratory rate (Breaths/min) will be evaluated
Measured: One hour after the recovery of spontaneous breathing
Secondary outcomes (2)
Driving pressure (DP)
Evaluation of the variations of DP in response to different levels of ventilatory assist at different degrees of lung inflation. The driving pressure formula is DP = P_plateau - PEEP. It represents the pressure difference between the plateau pressure (P_plateau) and the positive end-expiratory pressure (PEEP) during mechanical ventilation. Unit: mmHg or cmH2O.
Measured: One hour after the recovery of spontaneous breathing, with inspiratory hold manoeuvres
Occlusion Pression (Pocc)
Evaluation of the changes in the patient's respiratory effort (evaluated using Pocc) at different levels of ventilatory assist. The full breath occlusion pressure (Pocc) is the drop in airway-Pressre during a full occluded inspiratory effort. Unit: mmHg or cmH2O.
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 posted19 Jan 2023
- Study start27 Dec 2022
- Primary completion27 Dec 2025 (estimated)
- Study completion27 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689476
- Sponsor's protocol ID
- NAVAMECH
- Acronym
- NAVAMECH
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2023
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No