RAM Cannula Versus Short Bi-nasal Cannula in Respiratory Distress Syndrome
Condition: Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Study type: Interventional

Summary: 
      Noninvasive ventilation defines methods of providing ventilation support with constant or
      variable pressure using nasal or nasopharyngeal interfaces without endotracheal intubation or
      tracheostomy. Today, short binasal prongs and different types of nasal masks are the most
      commonly used nasal interfaces in the NICU with the aim of providing NIV.

      RAM cannula (Neotech ™, Valencia, CA), a new nasal interface, is increasingly used in NID
      applications in newborn infants. The RAM cannula is available in the inspiration and
      expiration arms of the stroke while reducing the dead space in the respiratory tract due to
      the low nasal prong diameter. There are not enough studies comparing the effectiveness of the
      RAM cannula with other short binasal prongs or nasal masks.

      Investigators compared the effectiveness and nasal injury rates of RAM cannula and short
      binasal prong as NIV interfaces in preterm infants.
    

Detailed description: 
      In the past years endotracheal intubation and mechanical ventilation with surfactant therapy
      was the standard treatment of moderate to severe respiratory distress syndrome (RDS).
      Especially in the last 10 years, prolonged intubation and positive pressure ventilation have
      been shown to increase the frequency of bronchopulmonary dysplasia, a kind of chronic
      pulmonary disease. Intubation and positive pressure ventilation cause volu-trauma,
      baro-trauma, and alveolar secondary to bio-trauma, leading to excessive distension and
      inflammation, disrupting alveolar formation, resulting in fibrosis and bronchopulmonary
      dysplasia. Intubation and mechanical ventilation also involve ventilator-associated
      pneumonia. For this reason, strategies for lung protective ventilation have become
      increasingly widespread in recent years and noninvasive ventilation (NNV) applications
      without endotracheal intubation have become the first choice in neonatal ventilation.

      Noninvasive ventilation defines methods of providing ventilation support with constant or
      variable pressure using nasal or nasopharyngeal interfaces without endotracheal intubation or
      tracheostomy. Noninvasive ventilation can be performed in a variety of forms such as
      continuous positive airway pressure (NCPAP) nasal intermittent positive-pressure ventilation
      (NIPPV) and high-flow nasal cannulae.

      Different nasal interfaces are used to provide noninvasive ventilation support. For this
      purpose, there is no standard apparatus used in neonatal intensive care units (NICU).
      Nasopharyngeal cannulae are not currently recommended for use with NIV because they cause
      extensive resistance during spontaneous breathing, nasopharyngeal area damage and
      colonization, although they have been widely used in previous years. Today, short binasal
      prongs and different types of nasal masks are the most commonly used nasal interfaces in the
      NICU with the aim of providing NIV. Nasal interfaces are recommended to be placed on the
      surface without causing pressure loss. For this purpose, hoods and fixing apparatus are
      frequently used. For this reason, babies often become restless and agitated during NIV
      applications. In addition, necrosis and deformities may develop in septum due to pressure of
      nasal septum.

      RAM cannula (Neotech ™, Valencia, CA), a new nasal interface, is increasingly used in NID
      applications in newborn infants. RAM seems ideal to allow effective and cranium development
      in the prevention of pressure damage to the face due to the design of the cannula and the
      need for head or face access to detect it. The RAM cannula is available in the inspiration
      and expiration arms of the stroke while reducing the dead space in the respiratory tract due
      to the low nasal prong diameter. Although the use of RAM cannula as a NIV interface in
      newborn intensive care units is becoming increasingly widespread, the number of studies
      related to RAM cannula is limited. Most of the studies investigating the effectiveness of
      this interface were made on artificial lung models. In the study of "Mukerji" and colleagues,
      the short binasal prong and RAM cannula were compared as interfaces in NIPPV application in
      the artificial lung model and it was found that carbon dioxide excretion in short binasal
      prongs was better than RAM cannula with an increase in peak inspiratory pressure. Studies
      conducted by Iyer and colleagues in the artificial lung model show that RAM leakage rates
      below 30% lead to adequate pressure transfer to the cannulae, while leakage rates above 50%
      reduce pressure transfer to the lungs. Similar results have also been found in the work of
      "Gerdes" et al. A number of studies have been conducted on the clinical use of RAM as a
      noninvasive ventilation interface and in these studies it has been shown that the use of RAM
      cannula as an interface in NCPAP, NIPPV or even nasal high frequency ventilation applications
      to provide NIV is not well tolerated and does not cause gastric perforation or nasal septum
      damage. In the study of "Nzegwu" et al. It has been shown that in two-thirds of the patients
      who were treated with RAM cannula and NIV support, the respiratory support was successfully
      cut off. Nevertheless, none of these studies compared the RAM cannula activity with the other
      binasal prongs or nasal masks. Investigators compared the effectiveness (rates of surfactant
      therapy application, rates of intubation, total NIV duration) and nasal injury rates of RAM
      cannula and short binasal prong as NIV interfaces in preterm infants at neonatal intensive
      care unit.

      Considering the studies made in the artificial lung models of RAM cannulas, which are
      becoming increasingly widespread in the NICUs, because of their simple and simple design and
      easy connection to the standard circuits of the ventilators without any intervention,
      investigators think that the effectiveness of NIV application is insufficient compared to the
      short binasal cannula.
    

Intervention name(s): nasal CPAP support with RAM cannula; nasal CPAP support with Hudson cannula
Intervention type(s): Device; Device
Intervention description(s): Patients with respiratory distress syndrome who do not need intubation in the delivery room. This groub will be provided with non-invasive respiratory support RAM cannula.; Patients with respiratory distress syndrome who do not need intubation in the delivery room. This groub will be provided with non-invasive respiratory support Hudson cannula.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Noninvasive ventilation, respiratory distress syndrome