Patient/Ventilator AsynchronyNAVAChildrenNCT01159106
The Use of Neurally Adjusted Ventilatory Assist (NAVA) Versus Pressure Support During Asynchrony in Children
A study testing Pressure Support Ventilation and Neurally adjusted ventilatory assist (NAVA) in people with Patient/Ventilator Asynchrony, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The aim of the current study is to compare the application neurally adjusted ventilatory assist (NAVA) to optimize pressure support ventilation in 12 pediatric patients. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Patient/Ventilator Asynchrony
- What is being tested?
- Pressure Support Ventilation and Neurally adjusted ventilatory assist (NAVA)
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2010to Jul 2011
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Trigger asynchrony
- Breath initiation asynchrony
- Breath termination asynchrony
- Patient ventilated by Servo i (Maquet Critical Care AB,Solna,Sweden)
- Patients breathing spontaneously with no control breaths
Who cannot join
- Shock
- Agitation
- Asynchrony caused by pain
- Abundant tracheal secretions
Trial locations and contacts
1 site in 1 country.
Pedro De La Oliva, MD, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Pedro de la Oliva, MD PhD, +347277149, poliva.hulp@salud.madrid.org
Pedro de la Oliva, MD PhD
About this study
Official title: The Use of NAVA vs. Pressure Support During Asynchrony in Children
The aim of the current study is to compare the application neurally adjusted ventilatory assist (NAVA) to optimize pressure support ventilation in 12 pediatric patients.
Read the detailed description
Asynchrony during assisted ventilation in children is common because of the presence of uncuffed artificial airways and their rapid ventilatory rate with small volumes compared to adults.As a result, the most common approach to ventilatory support in children is pressure ventilation, since pressure targeted ventilation allows gas delivery to vary based on patient demand. In addition, many manufacturers have incorporated adjuncts designed to improve synchrony in pressure targeted ventilation. Most of today's ICU ventilators incorporate rise time and control of the breath termination criteria in pressure ventilation by either altering inspiratory time directly or adjusting the inspiratory flow termination criteria in pressure support ventilation. In addition, careful adjustment of trigger sensitivity, and insuring driving pressure is appropriately set to avoid large tidal volumes improves synchrony in many patients. However, in spite of all of these potential adjustments many pediatric patients are still asynchronous.
A recently released new mode of ventilation, NAVA (neurally adjusted ventilatory assist) is designed to reduce the asynchrony that exists between the ventilator and the patient. With NAVA, gas delivery from the mechanical ventilator is triggered, controlled and cycled by the diaphragmatic EMG signal (Edi). The ventilator is aware of the change in diaphragmatic EMG by the insertion of a specially designed nasogastric tube (NGT) with EMG electrodes that cross the diaphragm. This NGT also functions similar to any standard NGT. NAVA is used to control all aspects of assisted ventilatory support. A number of preliminary studies in neonates and pediatric patients have demonstrated that patient ventilator synchrony is improved with the application of NAVA. In general, tidal volumes delivered by the ventilator are decreased, respiratory rates increased and peak inspiratory pressures decreased. In these studies, triggering and cycling of the ventilator are controlled by the diaphragmatic EMG in more than 70 % of the time. If the EMG signal does not activate or terminate positive pressure backup flow/pressure/time signal, control gas delivery -as is customary in standard modes of ventilatory support- takes over.
We hypothesize that the use of NAVA will improve trigger and flow synchrony in children and insure that tidal volumes are normalized (6 to 8 ml/kg) in these patients.
Asynchrony will be studied in 12 mechanically ventilated pediatric patients in the Pediatric ICU at Hospital Universitario Materno-Infantil La Paz in Madrid, Spain.
The study protocol has 5 phases
- Phase 0: patient asynchrony documentation and 10 min recording
- Phase 1: NAVA catheter insertion and 10 min recording in basal ventilatory mode after 20 min stabilization
- Phase 2: Pressure support is optimized and 10 min recording after 20 min stabilization
- Phase 3: NAVA mode ventilation and 10 min recording after 20 min stabilization
- Phase 4: Pressure support ventilation and 10 min recording after 20 min stabilization
- Conditions
- Patient/Ventilator Asynchrony
- Being tested
- Pressure Support Ventilation, Neurally adjusted ventilatory assist (NAVA)
- Keywords
- Positive Pressure Ventilation, Neurally Adjusted Ventilatory Assist, Patient/ventilator Asynchrony, Pediatric patient, Infant
- Medical subject headings
- Patient-Ventilator Asynchrony
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Support VentilationOther
Spontaneous mode of ventilation whereby the patient initiates the breath and the ventilator delivers support with the preset pressure value
Neurally adjusted ventilatory assist (NAVA)Other
Gas delivery from the mechanical ventilator is triggered, controlled and cycled by the diaphragmatic EMG signal (Edi).
The ventilator is aware of the change in diaphragmatic EMG by the insertion of a specially designed nasogastric tube with EMG electrodes that cross the diaphragm.
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of asynchrony
Number of each defined forms of asynchrony per minute during pressure support and during NAVA Six forms of asynchrony will be identified during optimal pressure support and optimal NAVA: trigger asynchrony, breath initiation asynchrony and breath termination asynchrony, demand asynchrony, inspiratory asynchrony and neuro-asynchrony
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patient/Ventilator AsynchronyStudies 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
- Diagnosis
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Investigators
- Robert M Kacmarek, PhD RRT FCCM, Study director, Massachusetts General HospitalPedro de la Oliva, MD PhD, Principal investigator, Hospital Universitario La PazJesus Villar, MD PhD, Principal investigator, Hospital Universitario Dr. NegrinDemet Suleymanci, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159106
- Sponsor's protocol ID
- HULP-PI-3132
- Acronym
- NAVAChildren
- Status last verified
- Jul 2010
- First submitted
- 8 Jul 2010
- Last updated
- 9 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Beck J, Tucci M, Emeriaud G, Lacroix J, Sinderby C. Prolonged neural expiratory time induced by mechanical ventilation in infants. Pediatr Res. 2004 May;55(5):747-54. doi: 10.1203/01.PDR.0000119368.21770.33. Epub 2004 Jan 22.
PubMed 14739354Spahija J, de Marchie M, Albert M, Bellemare P, Delisle S, Beck J, Sinderby C. Patient-ventilator interaction during pressure support ventilation and neurally adjusted ventilatory assist. Crit Care Med. 2010 Feb;38(2):518-26. doi: 10.1097/CCM.0b013e3181cb0d7b.
PubMed 20083921Breatnach C, Conlon NP, Stack M, Healy M, O'Hare BP. A prospective crossover comparison of neurally adjusted ventilatory assist and pressure-support ventilation in a pediatric and neonatal intensive care unit population. Pediatr Crit Care Med. 2010 Jan;11(1):7-11. doi: 10.1097/PCC.0b013e3181b0630f.
PubMed 19593246de la Oliva P, Schuffelmann C, Gomez-Zamora A, Villar J, Kacmarek RM. Asynchrony, neural drive, ventilatory variability and COMFORT: NAVA versus pressure support in pediatric patients. A non-randomized cross-over trial. Intensive Care Med. 2012 May;38(5):838-46. doi: 10.1007/s00134-012-2535-y. Epub 2012 Apr 6.
PubMed 22481227
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of NAVA vs. Pressure Support During Asynchrony in Children
- ClinicalTrials.gov ID
- NCT01159106
- Acronym / sponsor ID
- NAVAChildren / HULP-PI-3132
- Conditions
- Patient/Ventilator Asynchrony
- Keywords
- Positive Pressure Ventilation, Neurally Adjusted Ventilatory Assist, Patient/ventilator Asynchrony, Pediatric patient, Infant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 9 Jul 2010 (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.
The aim of the current study is to compare the application neurally adjusted ventilatory assist (NAVA) to optimize pressure support ventilation in 12 pediatric patients.
Detailed description
Asynchrony during assisted ventilation in children is common because of the presence of uncuffed artificial airways and their rapid ventilatory rate with small volumes compared to adults.As a result, the most common approach to ventilatory support in children is pressure ventilation, since pressure targeted ventilation allows gas delivery to vary based on patient demand. In addition, many manufacturers have incorporated adjuncts designed to improve synchrony in pressure targeted ventilation. Most of today's ICU ventilators incorporate rise time and control of the breath termination criteria in pressure ventilation by either altering inspiratory time directly or adjusting the inspiratory flow termination criteria in pressure support ventilation. In addition, careful adjustment of trigger sensitivity, and insuring driving pressure is appropriately set to avoid large tidal volumes improves synchrony in many patients. However, in spite of all of these potential adjustments many pediatric patients are still asynchronous.
A recently released new mode of ventilation, NAVA (neurally adjusted ventilatory assist) is designed to reduce the asynchrony that exists between the ventilator and the patient. With NAVA, gas delivery from the mechanical ventilator is triggered, controlled and cycled by the diaphragmatic EMG signal (Edi). The ventilator is aware of the change in diaphragmatic EMG by the insertion of a specially designed nasogastric tube (NGT) with EMG electrodes that cross the diaphragm. This NGT also functions similar to any standard NGT. NAVA is used to control all aspects of assisted ventilatory support. A number of preliminary studies in neonates and pediatric patients have demonstrated that patient ventilator synchrony is improved with the application of NAVA. In general, tidal volumes delivered by the ventilator are decreased, respiratory rates increased and peak inspiratory pressures decreased. In these studies, triggering and cycling of the ventilator are controlled by the diaphragmatic EMG in more than 70 % of the time. If the EMG signal does not activate or terminate positive pressure backup flow/pressure/time signal, control gas delivery -as is customary in standard modes of ventilatory support- takes over.
We hypothesize that the use of NAVA will improve trigger and flow synchrony in children and insure that tidal volumes are normalized (6 to 8 ml/kg) in these patients.
Asynchrony will be studied in 12 mechanically ventilated pediatric patients in the Pediatric ICU at Hospital Universitario Materno-Infantil La Paz in Madrid, Spain.
The study protocol has 5 phases
- Phase 0: patient asynchrony documentation and 10 min recording
- Phase 1: NAVA catheter insertion and 10 min recording in basal ventilatory mode after 20 min stabilization
- Phase 2: Pressure support is optimized and 10 min recording after 20 min stabilization
- Phase 3: NAVA mode ventilation and 10 min recording after 20 min stabilization
- Phase 4: Pressure support ventilation and 10 min recording after 20 min stabilization
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Trigger asynchrony
- Breath initiation asynchrony
- Breath termination asynchrony
- Patient ventilated by Servo i (Maquet Critical Care AB,Solna,Sweden)
- Patients breathing spontaneously with no control breaths
Key exclusion criteria (4 listed)
- Shock
- Agitation
- Asynchrony caused by pain
- Abundant tracheal secretions
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 |
|---|---|---|
| Pressure Support VentilationSpontaneous mode of ventilation whereby the patient initiates the breath and the ventilator delivers support with the preset pressure value | Other | – |
| Neurally adjusted ventilatory assist (NAVA)Gas delivery from the mechanical ventilator is triggered, controlled and cycled by the diaphragmatic EMG signal (Edi). The ventilator is aware of the change in diaphragmatic EMG by the insertion of a specially designed nasogastric tube with EMG electrodes that cross the diaphragm. | Other | – |
Primary outcome
Level of asynchrony
Time frame: 3 hours
Number of each defined forms of asynchrony per minute during pressure support and during NAVA Six forms of asynchrony will be identified during optimal pressure support and optimal NAVA: trigger asynchrony, breath initiation asynchrony and breath termination asynchrony, demand asynchrony, inspiratory asynchrony and neuro-asynchrony
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2010.
- Background: PubMed 14739354Beck J, Tucci M, Emeriaud G, Lacroix J, Sinderby C. Prolonged neural expiratory time induced by mechanical ventilation in infants. Pediatr Res. 2004 May;55(5):747-54. doi: 10.1203/01.PDR.0000119368.21770.33. Epub 2004 Jan 22.
- Background: PubMed 20083921Spahija J, de Marchie M, Albert M, Bellemare P, Delisle S, Beck J, Sinderby C. Patient-ventilator interaction during pressure support ventilation and neurally adjusted ventilatory assist. Crit Care Med. 2010 Feb;38(2):518-26. doi: 10.1097/CCM.0b013e3181cb0d7b.
- Background: PubMed 19593246Breatnach C, Conlon NP, Stack M, Healy M, O'Hare BP. A prospective crossover comparison of neurally adjusted ventilatory assist and pressure-support ventilation in a pediatric and neonatal intensive care unit population. Pediatr Crit Care Med. 2010 Jan;11(1):7-11. doi: 10.1097/PCC.0b013e3181b0630f.
- Derived from this study: PubMed 22481227de la Oliva P, Schuffelmann C, Gomez-Zamora A, Villar J, Kacmarek RM. Asynchrony, neural drive, ventilatory variability and COMFORT: NAVA versus pressure support in pediatric patients. A non-randomized cross-over trial. Intensive Care Med. 2012 May;38(5):838-46. doi: 10.1007/s00134-012-2535-y. Epub 2012 Apr 6.
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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.
Pedro De La Oliva, MD, PhD contact
Robert M Kacmarek, PhD RRT FCCM study director
Massachusetts General Hospital
Pedro de la Oliva, MD PhD principal investigator
Hospital Universitario La Paz
Jesus Villar, MD PhD principal investigator
Hospital Universitario Dr. Negrin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure Support Ventilation and Neurally adjusted ventilatory assist (NAVA) in people with Patient/Ventilator Asynchrony, run by Hospital Universitario La Paz at 1 site in Spain.
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 4 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 9 Jul 2010. 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 Spain. 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 Pedro De La Oliva, MD, PhD (poliva.hulp@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of asynchrony (time frame: 3 hours). 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 NCT01159106, which also lists 4 linked publications.
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 9 Jul 2010.