Respiratory FailureNCT01504373
Regional Distribution Differences Between Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation
An observational study of Respiratory Failure, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Neurally adjusted ventilatory assist (NAVA) is an FDA approved mode of mechanical ventilation. This mode of ventilation is currently in routine use in adult, pediatric and neonatal intensive care units. The electrical activity of the diaphragm, the largest muscle used during inspiration, is measured. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Neurally Adjusted Ventilatory Assist (NAVA)
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Apr 2020
- Phase
- Observational
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All intubated and mechanically ventilated patients in our intensive care units (ICUs) will be screened for the following inclusion criteria:
- Age: 1 month to 18 years.
- Mechanically ventilated for longer than 6 hours
- Either:
- Eligible for a spontaneous breathing mode of ventilation (not receiving chemical paralytics and has an appropriate spontaneous respiratory drive/rate given the size and condition of the patient) as determined by the team.
- or
- Currently in the pressure support ventilation (PSV) or neurally adjusted ventilatory assist (NAVA) mode of ventilation
Who cannot join
- Patients in which a nasal gastric or oral gastric tube is contraindicated. Examples are but not limited to: s/p esophagus, tracheal surgery, bleeding disorders, facial trauma.
- Uncuffed endotracheal tube (ETT)
- Cervical-spine injury that prohibits rolling the patient for electrical impedance tomography (EIT) band placement.
- Difficult airway
- Congenital cyanotic heart defects
- Positive end expiratory pressure (PEEP) > 15 cmH2O
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- Fractional inspired oxygen concentration (FIO2) > 0.8
- Peak inspiratory pressure (PIP) > 30 cmH2O
- Patients who are receiving chemical paralysis
- History of prematurity (birth at post-conceptual age <37 weeks)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Neurally adjusted ventilatory assist (NAVA) is an FDA approved mode of mechanical ventilation. This mode of ventilation is currently in routine use in adult, pediatric and neonatal intensive care units. The electrical activity of the diaphragm, the largest muscle used during inspiration, is measured. The ventilator triggers (synchronizes patient effort) and applies proportional assistance based on measured electrical activity of the diaphragm (Edi). This electrical activity is measured through a feeding tube that also has a multiple-array esophageal electrode in it. This mode of ventilation has been proven to be equivalent to pressure support ventilation (PSV). Theoretically, the breath-to-breath control offered by NAVA may not only trigger faster and synchronize better, but provide the support deemed appropriate by the central nervous center on demand. Traditionally in the intensive care unit (ICU), pressure support is applied to subject breathing spontaneously. Pressure is set to achieve a given tidal volume. The influence of changing lung compliance not only from the lung disease itself, but the interactions of the respiratory muscles can drastically change minute ventilation and contribute to hyper- or hypoventilation. These changes are typically found on assessment of end-tidal carbon dioxide (CO2), blood gas, or oxygen saturation (SpO2) monitoring; all of which are potentially preventable if we allowed the central nervous system to control the ventilator. NAVA may allow us to couple the central nervous system (neuro-coupling) with the ventilator to provide real-time proportional assistance, reduce work of breathing and apply physiologic breathing patterns.
- Conditions
- Respiratory Failure
- Being tested
- Neurally Adjusted Ventilatory Assist (NAVA)
- Keywords
- NAVA, neurally adjusted ventilatory support, lung injury, ventilation, lung volume distribution, oxygen cost of breathing
- Medical subject headings
- Respiratory Insufficiency, Lung Injury, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurally Adjusted Ventilatory Assist (NAVA)Device
Subjects will be placed in the NAVA mode of ventilation.
| Study group | Role | What they receive |
|---|---|---|
| NAVA-PSV | Subject will receive 4 hours of NAVA followed by 4 hours of PSV. Receives: Device: Neurally Adjusted Ventilatory Assist (NAVA) | |
| PSV-NAVA | Subject will receive 4 hours of PSV followed by 4 hours of NAVA. Receives: Device: Neurally Adjusted Ventilatory Assist (NAVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional distribution difference measured by electrical impedence tomography (EIT)
Regional distribution difference measured by EIT. Area and upper to lower lung volume ratios (as determined with EIT) will be the primary data analyzed. Global and regional filling of the lung will be compared during pressure support ventilation and neurally adjusted ventilatory assist.
Measured: Change from baseline regional distribution of ventilation after the 4th hour and after 8th hour
Oxygen and metabolic cost of breathing
Oxygen consumption (VO2), carbon dioxide production (VCO2), respiratory quotient (RQ), and Work of breathing (VO2/time) will be measured and compared between baseline, pressure support ventilation (PSV), and neurally adjusted ventilatory assist (NAVA) within each patient. Percent change will be compared between control (PSV) and NAVA group.
Measured: Change from baseline oxygen cost of breathing and carbon dioxide production after the 4th hour and after the 8th hour
Secondary outcomes (2)
Oxygenation
Oxygen saturation measured by pulse oxymetry (SpO2), SpO2/FiO2 ratio, non-invasive oxygen content (SpOC), and frequency of desaturations will be recorded continuously and compared between pressure support ventilation (PSV) and neurally adjusted ventilatory assist (NAVA). Although not a primary outcome measure of this study, oxygenation will allow us to further determine the safety of NAVA compared to PSV.
Measured: Monitored/recorded continuously for duration of study (8 hours total)
Lung mechanics
Compliance, peak inspiratory pressures, positive end expiratory pressure, tidal volumes, inspired oxygen concentration, electrical activity of the diaphragm (Edi), specific Edi (ratio of tidal volume to Edi), will be measured in each patient during pressure support ventilation and neurally adjusted ventilatory assist.
Measured: Monitored/recorded every 30 seconds for duration of study (8 hours total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startMay 2011
- Primary completionApr 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan Rettig, Boston Children's Hospital
- Investigators
- John Arnold, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504373
- Sponsor's protocol ID
- 10070341
- Status last verified
- Nov 2022
- First submitted
- 4 Nov 2011
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Distribution Differences Between Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation
- ClinicalTrials.gov ID
- NCT01504373
- Acronym / sponsor ID
- 10070341
- Conditions
- Respiratory Failure
- Keywords
- NAVA, neurally adjusted ventilatory support, lung injury, ventilation, lung volume distribution, oxygen cost of breathing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 5 Jan 2012 (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 an FDA approved mode of mechanical ventilation. This mode of ventilation is currently in routine use in adult, pediatric and neonatal intensive care units. The electrical activity of the diaphragm, the largest muscle used during inspiration, is measured. The ventilator triggers (synchronizes patient effort) and applies proportional assistance based on measured electrical activity of the diaphragm (Edi). This electrical activity is measured through a feeding tube that also has a multiple-array esophageal electrode in it. This mode of ventilation has been proven to be equivalent to pressure support ventilation (PSV). Theoretically, the breath-to-breath control offered by NAVA may not only trigger faster and synchronize better, but provide the support deemed appropriate by the central nervous center on demand. Traditionally in the intensive care unit (ICU), pressure support is applied to subject breathing spontaneously. Pressure is set to achieve a given tidal volume. The influence of changing lung compliance not only from the lung disease itself, but the interactions of the respiratory muscles can drastically change minute ventilation and contribute to hyper- or hypoventilation. These changes are typically found on assessment of end-tidal carbon dioxide (CO2), blood gas, or oxygen saturation (SpO2) monitoring; all of which are potentially preventable if we allowed the central nervous system to control the ventilator. NAVA may allow us to couple the central nervous system (neuro-coupling) with the ventilator to provide real-time proportional assistance, reduce work of breathing and apply physiologic breathing patterns.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAVA-PSV | – | Device: Neurally Adjusted Ventilatory Assist (NAVA)Subject will receive 4 hours of NAVA followed by 4 hours of PSV. |
| PSV-NAVA | – | Device: Neurally Adjusted Ventilatory Assist (NAVA)Subject will receive 4 hours of PSV followed by 4 hours of NAVA. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- All intubated and mechanically ventilated patients in our intensive care units (ICUs) will be screened for the following inclusion criteria:
- or
Key exclusion criteria (10 listed)
- Patients in which a nasal gastric or oral gastric tube is contraindicated. Examples are but not limited to: s/p esophagus, tracheal surgery, bleeding disorders, facial trauma.
- Uncuffed endotracheal tube (ETT)
- Cervical-spine injury that prohibits rolling the patient for electrical impedance tomography (EIT) band placement.
- Difficult airway
- Congenital cyanotic heart defects
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 |
|---|---|---|
| Neurally Adjusted Ventilatory Assist (NAVA)Subjects will be placed in the NAVA mode of ventilation. | Device | NAVA-PSV, PSV-NAVA |
Primary outcome
Regional distribution difference measured by electrical impedence tomography (EIT)
Time frame: Change from baseline regional distribution of ventilation after the 4th hour and after 8th hour
Regional distribution difference measured by EIT. Area and upper to lower lung volume ratios (as determined with EIT) will be the primary data analyzed. Global and regional filling of the lung will be compared during pressure support ventilation and neurally adjusted ventilatory assist.
Oxygen and metabolic cost of breathing
Time frame: Change from baseline oxygen cost of breathing and carbon dioxide production after the 4th hour and after the 8th hour
Oxygen consumption (VO2), carbon dioxide production (VCO2), respiratory quotient (RQ), and Work of breathing (VO2/time) will be measured and compared between baseline, pressure support ventilation (PSV), and neurally adjusted ventilatory assist (NAVA) within each patient. Percent change will be compared between control (PSV) and NAVA group.
2 secondary outcomes
Oxygenation
Time frame: Monitored/recorded continuously for duration of study (8 hours total)
Lung mechanics
Time frame: Monitored/recorded every 30 seconds for duration of study (8 hours total)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
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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.
John Arnold, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure, run by Boston Children's Hospital at 1 site in United States.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 16 Nov 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional distribution difference measured by electrical impedence tomography (EIT) (time frame: Change from baseline regional distribution of ventilation after the 4th hour and after 8th hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2022.