Acute Respiratory FailureNCT02043990
Adjusted Ventilatory Assist (NAVA-NIV) in Infants: Short-term Physiological Study
A study testing Noninvasive NAVA ventilation in people with Acute Respiratory Failure, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (EAdi), as assessed by trans-esophageal electromyography. Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Noninvasive NAVA ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to May 2014
- 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 1 month to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants aging > 1 month and < 2 yrs
- ARF (PaO2/FiO2 < 300 mmHg)
- Accessory muscle recruitment
- Respiratory Rate more than 2 SD related to age
- Intact neuromuscular pathway to the diaphragm
Who cannot join
- Hemodynamic instability
- Facial Surgery
- Reduction in airway protection
- Coma
- Contraindication to insert the nasogastric catheter
- Heart and lung transplant
Show all 9Show fewer
- Increase in PIC
- Refusal of the parents or legal guardian
- Enrolment in other research protocols
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122
Giovanna Chidini, MD
About this study
Official title: Patient Ventilator Interaction During Non-invasive Ventilation Delivered With Neurally Adjusted Ventilatory Assist (NAVA-NIV) in Infants
Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (EAdi), as assessed by trans-esophageal electromyography. To test the hypothesis that NAVA could provide better patient-ventilator synchrony during NIV delivered by nasal-facial mask as compared to conventional flow-triggered PSV in infants with Acute Respiratory Failure.
Read the detailed description
Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the machine applies positive pressure throughout inspiration in proportion to the Electrical Activity of the diaphragm (EAdi), as assessed by trans-esophageal electromyography. Because ventilator functioning and cycling are under control of the patient's respiratory drive and rhythm, NAVA has the potential to enhance patient-ventilator interaction ensuring synchrony and minimizing the risk of over-assistance. A high incidence of asynchrony events has been demonstrated to have a significant clinical impact by favouring weaning failure and longer duration of mechanical ventilation.
NAVA has been implemented safely in animals, in healthy volunteers and in critically ill adults and has been shown to improve patient-ventilator synchrony, to limit excessive airway pressure and tidal volume, and to unload the respiratory muscles in tracheally intubated patients.
Moreover NAVA was found to be effective in delivering non-invasive ventilation (NIV) even when the interface was excessively leaky (75% leak) with reduced positive end-expiratory pressure. With these conditions, NAVA was able to unload the respiratory muscles and preserve gas exchange, while maintaining synchrony to respiratory demand. To date, no data exist on the use of NAVA in infants during noninvasive ventilation. The aim of this physiological study is to compare patient-ventilator interaction in infants receiving NIV by NAVA and Pressure Support Ventilation (PSV).
- Conditions
- Acute Respiratory Failure
- Being tested
- Noninvasive NAVA ventilation
- Keywords
- NAVA, noninvasive ventilation, infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive NAVA ventilationDevice
Noninvasive NAVA Ventilation versus conventional noninvasive Pressure Support Ventilation
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive NAVA Ventilation | Experimental | Noninvasive NAVA Ventilation versus conventional noninvasive Pressure Support Ventilation Receives: Device: Noninvasive NAVA ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asynchrony Index
Measured: 60 minutes of each ventilatory trial, PSV or NAVA
Secondary outcomes (1)
Arterial blood gases
Measured: End of each ventilatory trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startMar 2013
- Primary completionMar 2014 (estimated)
- Study completionMay 2014 (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 Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanna Chidini, MD, Principal investigator, Fondazione IRCCS Ca Granda Ospedale Maggiore PoliclinicoCalderini Edoardo, MD, Study chair, Fondazione IRCCS Ca Granda Ospedale Maggiore PoliclinicoGiorgio Conti, MD, Phd, Study chair, University Sacred Heart, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043990
- Sponsor's protocol ID
- GCHIDINI2013
- Status last verified
- Jan 2014
- First submitted
- 28 Apr 2013
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1) Colombo D, Cammarota G, Bergamaschi V, De Lucia M, Corte FD, Navalesi P. Physiologic response to varying levels of pressure support and neurally adjusted ventilatory assist in patients with acute respiratory failure. Intensive Care Med 2008;34:2010-2018. 2) Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med 1999;5:1433-1436. 3) Sinderby C, Beck J, Spahija J, de Marchie M, Lacroix J, Navalesi P, Slutsky AS. Inspiratory Muscle Unloading by Neurally Adjusted Ventilatory Assist during Maximal Inspiratory Efforts in Healthy Subjects. Chest 2007;131:711-717. 4) Beck J, Brander L, Slutsky AS, Reilly MC, Dunn MS, Sinderby C. Non-invasive neurally adjusted ventilatory assist in rabbits with acute lung injury. Intensive Care Med 2008;34:316-323
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Ventilator Interaction During Non-invasive Ventilation Delivered With Neurally Adjusted Ventilatory Assist (NAVA-NIV) in Infants
- ClinicalTrials.gov ID
- NCT02043990
- Acronym / sponsor ID
- GCHIDINI2013
- Conditions
- Acute Respiratory Failure
- Keywords
- NAVA, noninvasive ventilation, infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 23 Jan 2014 (estimated)
- 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.
Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (EAdi), as assessed by trans-esophageal electromyography. To test the hypothesis that NAVA could provide better patient-ventilator synchrony during NIV delivered by nasal-facial mask as compared to conventional flow-triggered PSV in infants with Acute Respiratory Failure.
Detailed description
Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the machine applies positive pressure throughout inspiration in proportion to the Electrical Activity of the diaphragm (EAdi), as assessed by trans-esophageal electromyography. Because ventilator functioning and cycling are under control of the patient's respiratory drive and rhythm, NAVA has the potential to enhance patient-ventilator interaction ensuring synchrony and minimizing the risk of over-assistance. A high incidence of asynchrony events has been demonstrated to have a significant clinical impact by favouring weaning failure and longer duration of mechanical ventilation.
NAVA has been implemented safely in animals, in healthy volunteers and in critically ill adults and has been shown to improve patient-ventilator synchrony, to limit excessive airway pressure and tidal volume, and to unload the respiratory muscles in tracheally intubated patients.
Moreover NAVA was found to be effective in delivering non-invasive ventilation (NIV) even when the interface was excessively leaky (75% leak) with reduced positive end-expiratory pressure. With these conditions, NAVA was able to unload the respiratory muscles and preserve gas exchange, while maintaining synchrony to respiratory demand. To date, no data exist on the use of NAVA in infants during noninvasive ventilation. The aim of this physiological study is to compare patient-ventilator interaction in infants receiving NIV by NAVA and Pressure Support Ventilation (PSV).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noninvasive NAVA Ventilation | Experimental | Device: Noninvasive NAVA ventilationNoninvasive NAVA Ventilation versus conventional noninvasive Pressure Support Ventilation |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants aging > 1 month and < 2 yrs
- ARF (PaO2/FiO2 < 300 mmHg)
- Accessory muscle recruitment
- Respiratory Rate more than 2 SD related to age
- Intact neuromuscular pathway to the diaphragm
Key exclusion criteria (9 listed)
- Hemodynamic instability
- Facial Surgery
- Reduction in airway protection
- Coma
- Contraindication to insert the nasogastric catheter
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 |
|---|---|---|
| Noninvasive NAVA ventilationNoninvasive NAVA Ventilation versus conventional noninvasive Pressure Support Ventilation | Device | Noninvasive NAVA Ventilation |
Primary outcome
Asynchrony Index
Time frame: 60 minutes of each ventilatory trial, PSV or NAVA
1 secondary outcome
Arterial blood gases
Time frame: End of each ventilatory trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
- Background1) Colombo D, Cammarota G, Bergamaschi V, De Lucia M, Corte FD, Navalesi P. Physiologic response to varying levels of pressure support and neurally adjusted ventilatory assist in patients with acute respiratory failure. Intensive Care Med 2008;34:2010-2018. 2) Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med 1999;5:1433-1436. 3) Sinderby C, Beck J, Spahija J, de Marchie M, Lacroix J, Navalesi P, Slutsky AS. Inspiratory Muscle Unloading by Neurally Adjusted Ventilatory Assist during Maximal Inspiratory Efforts in Healthy Subjects. Chest 2007;131:711-717. 4) Beck J, Brander L, Slutsky AS, Reilly MC, Dunn MS, Sinderby C. Non-invasive neurally adjusted ventilatory assist in rabbits with acute lung injury. Intensive Care Med 2008;34:316-323
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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.
Giovanna Chidini, MD principal investigator
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Calderini Edoardo, MD study chair
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Giorgio Conti, MD, Phd study chair
University Sacred Heart, Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive NAVA ventilation in people with Acute Respiratory Failure, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 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 5 inclusion and 9 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 23 Jan 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanna Chidini, MD (+39-2-55032242, giovannachid@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asynchrony Index (time frame: 60 minutes of each ventilatory trial, PSV or NAVA). 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 NCT02043990, 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 23 Jan 2014.