Pediatric Acute Respiratory FailurePhase 4NiNAVApedNCT01873521
Neurally Adjusted Ventilatory Assist (NAVA) vs. Pressure Support in Pediatric Acute Respiratory Failure
A Phase 4 study testing Non invasive ventilation in people with Pediatric Acute Respiratory Failure, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
It is hypothesized that the use of Neurally Adjusted Ventilatory Assist (NAVA) compared to pressure support to provide noninvasive ventilation to children will result in a decrease in the number of children with moderate to severe respiratory failure failing noninvasive ventilation and requiring endotracheal… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pediatric Acute Respiratory Failure
- What is being tested?
- Non invasive ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2014to Dec 2016
- Phase
- Phase 4
- 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
- Age > 1 month age or weight > 3 Kg to 18 years
- Not intubated.
- Admitted to the PICU.
- Minimally agitated/sedated: between -2 and +2 on the Richmond agitation-sedation scale (Table 2).
- Moderate/severe Pediatric Acute Respiratory failure of any origin evaluated after a period of respiratory stabilization (aspiration of secretions, physiotherapy, oxygen and nebulized therapy) defined as: a) Modified Silverman-Wood Downess test >or= 5 or <or= 9; b) Hypoxemic ARF(SpO2< 94% FiO2 0,5). c)Hypercapnic ARF (PaCO2 (mmHg) and/or pH <7,30)
- The attending pediatric intensive care physician believes that the patient is likely to require endotracheal intubation (ETI).
Who cannot join
- Patients younger than 1 month or older than 18 year
- Severe ARF defined as Modified Silverman-Wood Downes test >9.
- Patients who need immediate endotracheal intubation: i.e.: Severe ARF with signs of exhaustion
- Facial trauma/burns
- Recent facial, upper way, or upper gastrointestinal tract surgery excepting gastrostomy for feeding
- Fixed obstruction of the upper airway.
Show all 19Show fewer
- Inability to protect airway
- Life threatening hypoxemia defined as SpaO2 <90% with FiO2 > 0.8 on hi-flow oxygen.
- Hemodynamic instability: refractory at volume expansion >60 ml/kg and dopamine >10 mcg/kg/min
- Impaired consciousness defined as Glasgow coma scale < 10.
- Bowel obstruction.
- Untreated pneumothorax.
- Poor short term prognosis (high risk of death in the next 3 months)
- Known esophageal problem (hiatal hernia, esophageal varicosities)
- Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a NG tube.
- Neuromuscular disease
- Vomiting
- Cough or gag reflex impairment.
- 18. Cyanotic congenital heart disease. 19. Complete absence of cooperation 20. This patient has previously been randomized in the study. 21. Repeated extubation failures (>or= 2).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Pedro De la Oliva, MD,PhD, +34917277149, pedro.oliva@salud.madrid.org
Pedro De la Oliva, MD,PhD
About this study
Official title: A Multicentre, Randomized, Clinical Trial of Noninvasive Ventilation: Neurally Adjusted Ventilatory Assist (NAVA) vs. Pressure Support in Pediatric Acute Respiratory Failure - NINAVAPed Protocol
It is hypothesized that the use of Neurally Adjusted Ventilatory Assist (NAVA) compared to pressure support to provide noninvasive ventilation to children will result in a decrease in the number of children with moderate to severe respiratory failure failing noninvasive ventilation and requiring endotracheal intubation. It is further hypothesized that noninvasive ventilation with NAVA compared to pressure support will result in a decrease in the length of mechanical ventilation, and the length of PICU and hospital stay.
Read the detailed description
Mechanical ventilation (MV) refers to the use of life-support technology to perform the work of breathing for patients who are unable to breathe on their own. One of the most common reasons for a Pediatric Intensive Care Unit (PICU) admission is the need for mechanical ventilation. However, MV is associated with increased morbidity (endotracheal intubation, tracheal edema, atelectasis, cardiovascular instability, ventilator-associated pneumonia, bleeding, pneumothorax, chronic lung disease, etc), a long length of stay in the PICU and high health care costs. Noninvasive ventilation (NIV) has become a primary approach to ventilatory support of patients of all ages and it is estimated that it can avoid endotracheal intubation and replace conventional mechanical ventilation in around 60% of patients with acute respiratory failure. NIV has been shown to ameliorate clinical signs of failure and improve gas exchange while reducing the need for endotracheal intubation (ETI) thus avoiding the risks associated with invasive ventilation. NIV has been shown to decrease the length of mechanical ventilation, the risk of ventilator associated pneumonia, the sedation requirement, the length of ICU and hospital stay and mortality, while improving the ability to tolerate enteral feeds. NIV does not increase beside caregiver time and does decrease cost.
With children because of the difficulty in assuring the patient's cooperation, the lack of available high quality masks and the resulting size of the air leak, synchrony between the ventilatory pattern of the patient and the support provided by the ventilator is poor. This problem had lead to repeated failure of noninvasive ventilation in children. The primary mode of noninvasive ventilatory support is pressure support (NIV PS). This mode is triggered to inspiration and cycled to exhalation by changes in patient inspiratory gas flow. But with air leaks the ability of the ventilator to coordinate with the patient is decreased.
A new mode of ventilation, Neurally Adjusted Ventilatory Assist (NAVA) has been recently introduced. This mode triggers, cycles and regulates gas delivery based on the diaphragmatic EMG signal via a specially designed nasogastric tube (Edi). As a result, air leaks do not affect the ability of the ventilator to synchronize gas delivery with the patient increasing patient ventilator synchrony. Based on the operation of NAVA it is expected to increase the successful application of noninvasive ventilation to children.
- Conditions
- Pediatric Acute Respiratory Failure
- Being tested
- Non invasive ventilation
- 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.
Non invasive ventilationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| NIV PS | Active comparator | The patients in this arms will received non invasive ventilation in PS mode. Receives: Procedure: Non invasive ventilation |
| NIV NAVA | Active comparator | The patients in this arm will received non invasive ventilation in NAVA mode. Receives: Procedure: Non invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Avoiding endotracheal intubation
The primary objective of this study is to demonstrate that the use of NAVA to provide noninvasive ventilatory support (NIV NAVA) compared to pressure support (NIV PS) in pediatric patients with moderate to severe respiratory failure decreases the noninvasive ventilation failure rate by decreasing the number of patients requiring endotracheal intubation (ETI).
Measured: During non invasive ventilation, an average of 2-3 days.
Secondary outcomes (2)
Length (days) of PICU stay after NIV
Measured: Length (days) of PICU stay after NIV, an average of 1 week.
Length (days) hospital stay after NIV
Measured: Length (days) hospital stay after NIV, an average of 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startFeb 2014
- Primary completionSep 2014 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pediatric Acute Respiratory FailureStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Galicia, Hospital Universitario La Paz
- Investigators
- Robert M Kacmarek, PhD RRT FCCM, Study director, Massachusetts General Hospital, Boston, USAJesús Villar, MD,PhD, Principal investigator, Hospital Universitario Dr. Negrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873521
- Sponsor's protocol ID
- HULP-PI-3751
- Acronym
- NiNAVAped
- Status last verified
- Apr 2014
- First submitted
- 6 Jun 2013
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cheifetz IM. Invasive and noninvasive pediatric mechanical ventilation. Respir Care. 2003 Apr;48(4):442-53; discussion 453-8.
PubMed 12667269Al-Mutairi SS, Al-Deen JS. Non-invasive positive pressure ventilation in acute respiratory failure. An alternative modality to invasive ventilation at a general hospital. Saudi Med J. 2004 Feb;25(2):190-4.
PubMed 14968216L'HerE, Moriconi M, Texier F, Bouquin V, Kaba L, Renault A, Garo B, Boles JM. Non-invasive continuous positive airway pressure in acute hypoxaemic respiratory failure--experience of an emergency department. Eur J Emerg Med. 1998 Sep;5(3):313-8.
PubMed 9827833Bernet V, Hug MI, Frey B. Predictive factors for the success of noninvasive mask ventilation in infants and children with acute respiratory failure. Pediatr Crit Care Med. 2005 Nov;6(6):660-4. doi: 10.1097/01.pcc.0000170612.16938.f6.
PubMed 16276332Keenan SP, Sinuff T, Cook DJ, Hill NS. Does noninvasive positive pressure ventilation improve outcome in acute hypoxemic respiratory failure? A systematic review. Crit Care Med. 2004 Dec;32(12):2516-23. doi: 10.1097/01.ccm.0000148011.51681.e2.
PubMed 15599160Kendirli T, Kavaz A, Yalaki Z, Ozturk Hismi B, Derelli E, Ince E. Mechanical ventilation in children. Turk J Pediatr. 2006 Oct-Dec;48(4):323-7.
PubMed 17290566Calderini E, Chidini G, Pelosi P. What are the current indications for noninvasive ventilation in children? Curr Opin Anaesthesiol. 2010 Jun;23(3):368-74. doi: 10.1097/ACO.0b013e328339507b.
PubMed 20440111Essouri S, Durand P, Chevret L, Haas V, Perot C, Clement A, Devictor D, Fauroux B. Physiological effects of noninvasive positive ventilation during acute moderate hypercapnic respiratory insufficiency in children. Intensive Care Med. 2008 Dec;34(12):2248-55. doi: 10.1007/s00134-008-1202-9. Epub 2008 Aug 19.
PubMed 18712350Breatnach 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 19593246Biban P, Serra A, Polese G, Soffiati M, Santuz P. Neurally adjusted ventilatory assist: a new approach to mechanically ventilated infants. J Matern Fetal Neonatal Med. 2010 Oct;23 Suppl 3:38-40. doi: 10.3109/14767058.2010.510018.
PubMed 20828233Munoz-Bonet JI, Flor-Macian EM, Brines J, Rosello-Millet PM, Cruz Llopis M, Lopez-Prats JL, Castillo S. Predictive factors for the outcome of noninvasive ventilation in pediatric acute respiratory failure. Pediatr Crit Care Med. 2010 Nov;11(6):675-80. doi: 10.1097/PCC.0b013e3181d8e303.
PubMed 20308933
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Clinical Trial of Noninvasive Ventilation: Neurally Adjusted Ventilatory Assist (NAVA) vs. Pressure Support in Pediatric Acute Respiratory Failure - NINAVAPed Protocol
- ClinicalTrials.gov ID
- NCT01873521
- Acronym / sponsor ID
- NiNAVAped / HULP-PI-3751
- Conditions
- Pediatric Acute Respiratory Failure
- Keywords
- Positive Pressure Ventilation, Neurally Adjusted Ventilatory Assist, Patient/ventilator Asynchrony, Pediatric patient, Infant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Jun 2013 (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.
It is hypothesized that the use of Neurally Adjusted Ventilatory Assist (NAVA) compared to pressure support to provide noninvasive ventilation to children will result in a decrease in the number of children with moderate to severe respiratory failure failing noninvasive ventilation and requiring endotracheal intubation. It is further hypothesized that noninvasive ventilation with NAVA compared to pressure support will result in a decrease in the length of mechanical ventilation, and the length of PICU and hospital stay.
Detailed description
Mechanical ventilation (MV) refers to the use of life-support technology to perform the work of breathing for patients who are unable to breathe on their own. One of the most common reasons for a Pediatric Intensive Care Unit (PICU) admission is the need for mechanical ventilation. However, MV is associated with increased morbidity (endotracheal intubation, tracheal edema, atelectasis, cardiovascular instability, ventilator-associated pneumonia, bleeding, pneumothorax, chronic lung disease, etc), a long length of stay in the PICU and high health care costs. Noninvasive ventilation (NIV) has become a primary approach to ventilatory support of patients of all ages and it is estimated that it can avoid endotracheal intubation and replace conventional mechanical ventilation in around 60% of patients with acute respiratory failure. NIV has been shown to ameliorate clinical signs of failure and improve gas exchange while reducing the need for endotracheal intubation (ETI) thus avoiding the risks associated with invasive ventilation. NIV has been shown to decrease the length of mechanical ventilation, the risk of ventilator associated pneumonia, the sedation requirement, the length of ICU and hospital stay and mortality, while improving the ability to tolerate enteral feeds. NIV does not increase beside caregiver time and does decrease cost.
With children because of the difficulty in assuring the patient's cooperation, the lack of available high quality masks and the resulting size of the air leak, synchrony between the ventilatory pattern of the patient and the support provided by the ventilator is poor. This problem had lead to repeated failure of noninvasive ventilation in children. The primary mode of noninvasive ventilatory support is pressure support (NIV PS). This mode is triggered to inspiration and cycled to exhalation by changes in patient inspiratory gas flow. But with air leaks the ability of the ventilator to coordinate with the patient is decreased.
A new mode of ventilation, Neurally Adjusted Ventilatory Assist (NAVA) has been recently introduced. This mode triggers, cycles and regulates gas delivery based on the diaphragmatic EMG signal via a specially designed nasogastric tube (Edi). As a result, air leaks do not affect the ability of the ventilator to synchronize gas delivery with the patient increasing patient ventilator synchrony. Based on the operation of NAVA it is expected to increase the successful application of noninvasive ventilation to children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV PS | Active comparator | Procedure: Non invasive ventilationThe patients in this arms will received non invasive ventilation in PS mode. |
| NIV NAVA | Active comparator | Procedure: Non invasive ventilationThe patients in this arm will received non invasive ventilation in NAVA mode. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age > 1 month age or weight > 3 Kg to 18 years
- Not intubated.
- Admitted to the PICU.
- Minimally agitated/sedated: between -2 and +2 on the Richmond agitation-sedation scale (Table 2).
- Moderate/severe Pediatric Acute Respiratory failure of any origin evaluated after a period of respiratory stabilization (aspiration of secretions, physiotherapy, oxygen and nebulized therapy) defined as: a) Modified Silverman-Wood Downess test >or= 5 or <or= 9; b) Hypoxemic ARF(SpO2< 94% FiO2 0,5). c)Hypercapnic ARF (PaCO2 (mmHg) and/or pH <7,30)
Key exclusion criteria (19 listed)
- Patients younger than 1 month or older than 18 year
- Severe ARF defined as Modified Silverman-Wood Downes test >9.
- Patients who need immediate endotracheal intubation: i.e.: Severe ARF with signs of exhaustion
- Facial trauma/burns
- Recent facial, upper way, or upper gastrointestinal tract surgery excepting gastrostomy for feeding
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 |
|---|---|---|
| Non invasive ventilation | Procedure or surgery | NIV NAVA, NIV PS |
Primary outcome
Avoiding endotracheal intubation
Time frame: During non invasive ventilation, an average of 2-3 days.
The primary objective of this study is to demonstrate that the use of NAVA to provide noninvasive ventilatory support (NIV NAVA) compared to pressure support (NIV PS) in pediatric patients with moderate to severe respiratory failure decreases the noninvasive ventilation failure rate by decreasing the number of patients requiring endotracheal intubation (ETI).
2 secondary outcomes
Length (days) of PICU stay after NIV
Time frame: Length (days) of PICU stay after NIV, an average of 1 week.
Length (days) hospital stay after NIV
Time frame: Length (days) hospital stay after NIV, an average of 1-2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
- Background: PubMed 12667269Cheifetz IM. Invasive and noninvasive pediatric mechanical ventilation. Respir Care. 2003 Apr;48(4):442-53; discussion 453-8.
- Background: PubMed 14968216Al-Mutairi SS, Al-Deen JS. Non-invasive positive pressure ventilation in acute respiratory failure. An alternative modality to invasive ventilation at a general hospital. Saudi Med J. 2004 Feb;25(2):190-4.
- Background: PubMed 9827833L'HerE, Moriconi M, Texier F, Bouquin V, Kaba L, Renault A, Garo B, Boles JM. Non-invasive continuous positive airway pressure in acute hypoxaemic respiratory failure--experience of an emergency department. Eur J Emerg Med. 1998 Sep;5(3):313-8.
- Background: PubMed 16276332Bernet V, Hug MI, Frey B. Predictive factors for the success of noninvasive mask ventilation in infants and children with acute respiratory failure. Pediatr Crit Care Med. 2005 Nov;6(6):660-4. doi: 10.1097/01.pcc.0000170612.16938.f6.
- Background: PubMed 15599160Keenan SP, Sinuff T, Cook DJ, Hill NS. Does noninvasive positive pressure ventilation improve outcome in acute hypoxemic respiratory failure? A systematic review. Crit Care Med. 2004 Dec;32(12):2516-23. doi: 10.1097/01.ccm.0000148011.51681.e2.
- Background: PubMed 17290566Kendirli T, Kavaz A, Yalaki Z, Ozturk Hismi B, Derelli E, Ince E. Mechanical ventilation in children. Turk J Pediatr. 2006 Oct-Dec;48(4):323-7.
- Background: PubMed 20440111Calderini E, Chidini G, Pelosi P. What are the current indications for noninvasive ventilation in children? Curr Opin Anaesthesiol. 2010 Jun;23(3):368-74. doi: 10.1097/ACO.0b013e328339507b.
- Background: PubMed 18712350Essouri S, Durand P, Chevret L, Haas V, Perot C, Clement A, Devictor D, Fauroux B. Physiological effects of noninvasive positive ventilation during acute moderate hypercapnic respiratory insufficiency in children. Intensive Care Med. 2008 Dec;34(12):2248-55. doi: 10.1007/s00134-008-1202-9. Epub 2008 Aug 19.
- 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.
- Background: PubMed 20828233Biban P, Serra A, Polese G, Soffiati M, Santuz P. Neurally adjusted ventilatory assist: a new approach to mechanically ventilated infants. J Matern Fetal Neonatal Med. 2010 Oct;23 Suppl 3:38-40. doi: 10.3109/14767058.2010.510018.
- Background: PubMed 20308933Munoz-Bonet JI, Flor-Macian EM, Brines J, Rosello-Millet PM, Cruz Llopis M, Lopez-Prats JL, Castillo S. Predictive factors for the outcome of noninvasive ventilation in pediatric acute respiratory failure. Pediatr Crit Care Med. 2010 Nov;11(6):675-80. doi: 10.1097/PCC.0b013e3181d8e303.
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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.
Robert M Kacmarek, PhD RRT FCCM study director
Massachusetts General Hospital, Boston, USA
Jesús 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 Phase 4 study testing Non invasive ventilation in people with Pediatric Acute Respiratory Failure, 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 6 inclusion and 19 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 16 Apr 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (+34917277149, pedro.oliva@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Avoiding endotracheal intubation (time frame: During non invasive ventilation, an average of 2-3 days.). 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 NCT01873521, which also lists 11 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 16 Apr 2014.