Work of Breathing During Non-invasive Ventilation in Premature Neonates

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Brief Title

Work of Breathing During Non-invasive Ventilation in Premature Neonates

Official Title

Prospective Crossover Comparison of Work of Breathing During Non-invasive Ventilation: Neurally Adjusted Ventilatory Assist (NAVA) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) in Premature Neonates

Brief Summary

      Background:

      Non-invasive forms of respiratory support have been developed to manage respiratory distress
      and failure in premature newborns without exposing them to the risks associated with invasive
      mechanical ventilation. It has been difficult to synchronize non-invasive ventilation due to
      the large air leaks, high respiratory rates, and small tidal volumes inherent to this
      interface and population. Neurally adjusted ventilatory assist (NAVA) is a novel mode of
      ventilation that uses a functional naso/orogastric tube with embedded electrodes which detect
      diaphragmatic contractions (called the Edi signal). NAVA uses this Edi signal to synchronize
      ventilator support to the patient's own respiratory efforts and to support these efforts as
      needed. Few studies have examined the use of NAVA with non-invasive ventilation (NIV) in
      preterm neonates. A group at Arkansas Children's Hospital recently completed a study, looking
      at work of breathing in an animal model comparing NIV NAVA with the unsynchronized nasal
      intermittent positive pressure (NIPPV) mode currently used at this hospital. They were able
      to show that work of breathing was lower with NAVA in this model. This study will take what
      was shown in the animal model and translate this to the bedside. Using respiratory inductance
      plethysmography to measure thoracoabdominal asynchrony, this study will compare work of
      breathing during NIPPV versus NIV NAVA in preterm neonates with respiratory insufficiency.

      Hypothesis:

      Work of breathing as estimated by the phase angle (θ) using respiratory inductance
      plethysmography will be decreased with the use of NIV NAVA in comparison to unsynchronized
      NIPPV in premature neonates with respiratory insufficiency.

      Methods:

      Fifteen premature neonates of between 1-2 kilograms' current weight, with gestational age at
      birth between 24-34 weeks, and receiving non-invasive ventilation will be enrolled in the
      study after consent is obtained. The infants will be ventilated using NIV NAVA and NIPPV
      applied in random order for 15 minutes each while using respiratory inductance
      plethysmography to measure thoracoabdominal asynchrony as an estimate of work of breathing.

      Significance:

      This study will identify whether or not NIV NAVA has advantages over NIPPV for improving work
      of breathing in premature neonates.
    

Detailed Description

      Background/Rationale:

      Historically, respiratory insufficiency and respiratory failure have been frequent sources of
      morbidity and mortality in premature neonates. Intubation for invasive mechanical ventilation
      has been a life-saving therapy for many of these patients, but is not without risks. These
      risks include pulmonary complications such as volutrauma, extrapulmonary air leak syndromes,
      and traumatic injury to the large airways; non-pulmonary complications such as retinopathy of
      prematurity; and long-term complications such as bronchopulmonary dysplasia [Miller, Badiee].
      Concern over these effects of prolonged mechanical ventilation has led to the development of
      non-invasive forms of respiratory support.

      Non-invasive ventilation (NIV) is a frequently used modality of respiratory support for
      premature neonates in the setting of respiratory insufficiency or recent weaning from
      invasive ventilation. Synchronized NIV is effective at decreasing respiratory effort as
      compared to unsynchronized NIV and nasal continuous positive airway pressure (NCPAP) [Chang].
      Synchronizing NIV in premature neonates to the patient's own respiratory efforts is difficult
      because of the large air leaks, weak inspiratory efforts, and high respiratory rates inherent
      to this population [Vignaux].

      A novel method of synchronization, neurally adjusted ventilatory assist (NAVA) uses
      electrodes on a functional naso/orogastric tube (Edi catheter) to detect diaphragm
      contractions and time the onset, duration, and peak inspiratory pressure of supporting
      breaths with the electrical activity of the diaphragm (Edi) [Sinderby]. NAVA can be used with
      both invasive and non-invasive ventilation modalities, and there have been several small
      studies examining invasive NAVA in children and adults [Stein, de la Olivia]. Fewer studies
      have examined NIV NAVA in these populations, and only two clinical trials have examined NIV
      NAVA in premature neonates [Beck, Lee]. Beck and colleagues in Canada showed feasibility and
      preservation of synchrony during NIV NAVA in premature neonates [Beck]. Lee and colleagues in
      Korea showed fewer asynchrony events, lower trigger delay, and lower peak inspiratory
      pressures with NIV NAVA compared to non-invasive pressure support ventilation in premature
      neonates [Lee]. Neither study examined work of breathing (WOB) in preterm neonates ventilated
      with NIV NAVA.

      Work of breathing during assisted ventilation is the portion of the driving pressure for
      ventilation contributed by the patient's respiratory muscles. A research team at Arkansas
      Children's Hospital was able to demonstrate that NAVA achieves reduced response time, work of
      breathing, and asynchrony with neurally triggered breaths as compared to pneumatically
      triggered breaths in an animal model [Heulitt]. This team was also able to show similar
      results in a clinical study of intubated pediatric patients with bronchiolitis [Clement]. A
      recently completed study at this institution looked at work of breathing in neonatal pigs
      comparing NIV NAVA with the unsynchronized nasal intermittent positive pressure (NIPPV) mode
      currently used at this hospital. Using the pressure-time product (PTP) as a measure of WOB
      this study was able to show that WOB was lower with NAVA. The PTP cannot be reliably used in
      infants on NIV because the nasal prong interface allows large air leaks at the nose and
      mouth, which interfere with accurate measurements.

      Thoracoabdominal asynchrony (TAA) is an important correlate of WOB and increased respiratory
      load in preterm infants and can be measured without invasive monitoring. TAA can be measured
      using a respiratory inductance plethysmography (RIP) bands around the patient's chest and
      abdomen to quantify chest wall and abdominal movement. The degree of asynchrony between the
      two compartments is reflected in the phase angle (θ), which can be calculated from the RIP
      band measurements.

      This study will examine estimated WOB in a population of premature neonates with respiratory
      insufficiency currently on non-invasive support. Infants will serve as their own controls and
      will be studied on NIV NAVA and NIPPV. Order of assignment will be randomized. Researchers
      will use RIP bands to measure thoracic and abdominal movement, then calculate the phase angle
      (θ) as an estimate of WOB. Study personnel will measure other respiratory parameters
      correlating with ventilation and gas exchange including the following: tidal volume
      (arbitrary units, AU), minute ventilation (AU/min), respiratory rate, transcutaneous oxygen
      and carbon dioxide, oxygen saturation and FiO2 requirement, peak inspiratory pressure, and
      delivered end expiratory pressure. Investigators will also evaluate measures of breathing
      asynchrony to include trigger delay (time between initial increase in Edi signal and
      initiation of delivered ventilator flow) and asynchrony index (number of asynchrony events
      divided by total events, as a percent).

      Study Design/Procedures/Population:

      Fifteen premature neonates of between 1-2 kilogram current weight, with gestational age at
      birth between 24-34 weeks, and receiving non-invasive ventilation will be enrolled in the
      study. Inclusion criteria will be as follows: respiratory insufficiency currently requiring
      non-invasive ventilation (either NIPPV or NAVA), current FiO2 requirement less than 0.40, and
      clinical stability. Exclusion criteria will be as follows: ionotropic support, clinical
      instability (temperature instability, heart failure, bleeding, active infection, significant
      apnea or bradycardia), known major congenital anomalies (congenital heart disease, abdominal
      wall defects, gastrointestinal tract defects, cleft palate, or neurologic defects), known
      cystic fibrosis, nitric oxide use, and cyanotic congenital heart disease.

      At the beginning of the study, RIP bands will be placed around the infant's chest and
      abdomen. An Edi catheter will be placed and the current gastric catheter may or may not be
      removed. Infants will be ventilated with the Servo i ventilator equipped with NIV NAVA
      software {Maquet, Solna, Sweden}. Data will be continuously and simultaneously acquired using
      the MP100 Biopac data acquisition system. Data acquired will be as follows: heart rate,
      oxygen saturation, transcutaneous CO2 and O2, PIP, PEEP, rib cage and abdominal RIP signals,
      summed tidal volume, and Edi. Infants will receive 15 minute trials of NIV NAVA and NIPPV in
      random order with the first 10 minutes after changing to be considered a washout period and
      the last 5 minutes used for data collection. The data recorded from the two RIP bands will be
      used to calculate the phase angle (θ) as an estimate of WOB.

      Risks and Benefits:

      Infants often have gagging and may have vomiting when a gastric tube, such as the NAVA
      catheter, is removed or replaced. Rarely, patients could have a gastric tube go into a place
      besides the stomach or coil in the esophagus. Researchers should be able to detect if this
      occurs using the placement screen on the ventilator because the NAVA catheter has electrodes
      on it that detect the electrical activity of the heart and diaphragm, which can be used to
      determine the location.

      In extremely low birth weight infants, transcutaneous monitors (TCOMs) can cause skin
      burning. These effects are not seen in larger babies like those included in this study.

      There is a small risk of loss of confidentiality inherent in all research. Investigators will
      do everything possible to protect the participants' confidentiality.

      There may or may not be direct medical benefit to the infants involved in this study. The
      infants will have continuous carbon dioxide and oxygen monitoring during the study and if any
      patient has any problems, study personnel will be able to detect and respond to this quickly.
      If a patient shows improvement while using NAVA, investigators may be able to suggest to the
      treatment team that this mode be continued. If using NAVA improves work of breathing in
      babies, then the researchers hope the information learned from this study will benefit other
      infants needing respiratory support in the future.

      Data Handling/Recordkeeping:

      The principal investigator will carefully monitor study procedures to protect the safety of
      research subjects, the quality of the data and the integrity of the study. Each patient will
      be assigned a unique identifying code or number. The key to the code will be kept in a locked
      file in the principal investigator's office. Only the principal investigator and
      co-investigators will have access to the code and information that identifies the subject in
      the study.

      Data Analysis:

      The primary hypothesis is that phase angle (θ) using respiratory inductance plethysmography
      will be decreased with the use of NAVA in comparison to NIPPV in our study sample.

      Data collected will be checked for outliers and extreme values, as well as distributional
      assumptions of the parametric statistical tests. Repeated measures ANOVA will be used to
      compare the primary and secondary outcomes under the two ventilation methods when such
      assumptions are met. When significant deviation from assumptions is encountered,
      nonparametric alternatives will be used. Statistical analyses will be performed using Stata
      (College Station, TX) statistical software.

      Sample Size, Power Calculation:

      Investigators plan to recruit 15-20 neonates who are 24-34 weeks gestation with respiratory
      insufficiency. Based on the results in the animal model, a 30% reduction in the primary
      outcome is expected. Since the average phase angle was found to be variable among preterm
      infants (ranged from 2.8-162.9), there are several scenarios of the sample size and power
      calculation presented for analysis [Ulm]. A sample size of 15 neonates achieves 82% power to
      detect a 30% change in the primary outcome with an estimated standard deviation of
      differences of 18.8, 37.5, or 56.3 respectively for an average phase angle of 50, 100, and
      150 degrees with the use of NIPPV. All calculations assume a significance level of 0.05 using
      a two-sided paired t-test.

      Ethical Considerations:

      This study will be conducted in accordance with all applicable government regulations and
      University of Arkansas for Medical Sciences (UAMS) research policies and procedures. This
      protocol and any amendments will be submitted and approved by the UAMS Institutional Review
      Board (IRB). The formal consent of each subject, using the IRB-approved consent form, will be
      obtained before that subject is submitted to any study procedure. All subjects for this study
      will be provided a consent form describing this study and providing sufficient information in
      language suitable for subjects to make an informed decision about their participation in this
      study. The person obtaining consent will thoroughly explain each element of the document and
      outline the risks and benefits, alternate treatment(s), and requirements of the study. The
      consent process will take place in a quiet and private room or by phone, and subjects may
      take as much time as needed to make a decision about their participation. Phone consent will
      be obtained with a witness and consent will be faxed to parent(s). Phone consent will only be
      obtained in the event that the parents are unable to be present.

      Participation privacy will be maintained and questions regarding participation will be
      answered. No coercion or undue influence will be used in the consent process. The consent
      form must be signed by the subject, the parent and the individual obtaining the consent. A
      copy of the signed consent will be given to the participant, and the informed consent process
      will be documented in each subject's research record.

      Dissemination of Data:

      Results of this study may be used for presentations, posters, or publications. The
      publications will not contain any identifiable information that could be linked to a
      participant.
    


Study Type

Interventional


Primary Outcome

Phase angle (θ)

Secondary Outcome

 Tidal volume (arbitrary units, AU)

Condition

Respiratory Distress Syndrome, Newborn

Intervention

Noninvasive neurally adjusted ventilatory assist (NIV NAVA)

Study Arms / Comparison Groups

 NIV NAVA then NIPPV
Description:  Infants will receive 15 minute trials of noninvasive neurally adjusted ventilatory assist (NIV NAVA) and nasal intermittent positive pressure ventilation (NIPPV) in random order with the first 10 minutes after changing to be considered a washout period and the last 5 minutes used for data collection. This group will receive NIV NAVA then NIPPV.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

15

Start Date

August 2016

Completion Date

June 2018

Primary Completion Date

June 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Gestational age at birth between 24 and 34 weeks

          -  Receiving noninvasive ventilation

          -  Between 1 and 2 kg current weight

          -  Current FiO2 requirement less than 0.40

          -  Clinical stability

        Exclusion Criteria:

          -  Known major congenital anomalies (congenital heart disease, abdominal wall defects,
             gastrointestinal tract defects, cleft palate, or neurologic defects)

          -  Clinical instability (temperature instability, heart failure, bleeding, active
             infection, significant apnea or bradycardia)

          -  Known cystic fibrosis

          -  Use of inhaled nitric oxide

          -  Cyanotic congenital heart disease
      

Gender

All

Ages

N/A - 12 Months

Accepts Healthy Volunteers

No

Contacts

David N Matlock, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02788110

Organization ID

IRB 205507


Responsible Party

Sponsor

Study Sponsor

Arkansas Children's Hospital Research Institute


Study Sponsor

David N Matlock, MD, Principal Investigator, University of Arkansas


Verification Date

January 2019