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RAM Cannula Versus Short Bi-nasal Cannula in Respiratory Distress Syndrome

Primary Purpose

Respiratory Distress Syndrome, Newborn

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
nasal CPAP support with RAM cannula
nasal CPAP support with Hudson cannula
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Distress Syndrome, Newborn focused on measuring Noninvasive ventilation, respiratory distress syndrome

Eligibility Criteria

1 Minute - 15 Minutes (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • gestational age between 26-34 weeks and,
  • born in our hospital and,
  • Patients with clinical findings (tachypnea, groaning, chest retractions) of RDS

Exclusion Criteria:

  • Patients who needed intubation to stabilize in the delivery room or who had severe congenital anomalies.

Sites / Locations

  • Turgut Özal Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RAM cannula

Hudson cannula (short binasal cannula)

Arm Description

nasal CPAP support with RAM cannula

nasal CPAP support with Hudson cannula

Outcomes

Primary Outcome Measures

Nasal IPPV failure
Non invasive ventilation failure in patients who underwent nasal IPPV with RAM cannula

Secondary Outcome Measures

NİV duration
In patients with NİV (nasal IPPV) who underwent RAM cannula or short binasal cannula (prong). We compared the time of NIV

Full Information

First Posted
November 24, 2017
Last Updated
February 18, 2020
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT03366714
Brief Title
RAM Cannula Versus Short Bi-nasal Cannula in Respiratory Distress Syndrome
Official Title
Comparison of Efficacy of Noninvasive Ventilation With RAM Cannula Versus Short Bi-nasal Cannula in Respiratory Distress Syndrome of Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
August 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn
Keywords
Noninvasive ventilation, respiratory distress syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAM cannula
Arm Type
Experimental
Arm Description
nasal CPAP support with RAM cannula
Arm Title
Hudson cannula (short binasal cannula)
Arm Type
Active Comparator
Arm Description
nasal CPAP support with Hudson cannula
Intervention Type
Device
Intervention Name(s)
nasal CPAP support with RAM cannula
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
nasal CPAP support with Hudson cannula
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nasal IPPV failure
Description
Non invasive ventilation failure in patients who underwent nasal IPPV with RAM cannula
Time Frame
up to four weeks
Secondary Outcome Measure Information:
Title
NİV duration
Description
In patients with NİV (nasal IPPV) who underwent RAM cannula or short binasal cannula (prong). We compared the time of NIV
Time Frame
up to two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
15 Minutes
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: gestational age between 26-34 weeks and, born in our hospital and, Patients with clinical findings (tachypnea, groaning, chest retractions) of RDS Exclusion Criteria: Patients who needed intubation to stabilize in the delivery room or who had severe congenital anomalies.
Facility Information:
Facility Name
Turgut Özal Medical Center
City
Malatya
ZIP/Postal Code
44280
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11517198
Citation
Davis P, Davies M, Faber B. A randomised controlled trial of two methods of delivering nasal continuous positive airway pressure after extubation to infants weighing less than 1000 g: binasal (Hudson) versus single nasal prongs. Arch Dis Child Fetal Neonatal Ed. 2001 Sep;85(2):F82-5. doi: 10.1136/fn.85.2.f82.
Results Reference
background
PubMed Identifier
25851534
Citation
Gerdes JS, Sivieri EM, Abbasi S. Factors influencing delivered mean airway pressure during nasal CPAP with the RAM cannula. Pediatr Pulmonol. 2016 Jan;51(1):60-9. doi: 10.1002/ppul.23197. Epub 2015 Apr 7.
Results Reference
background
PubMed Identifier
24874561
Citation
Nzegwu NI, Mack T, DellaVentura R, Dunphy L, Koval N, Levit O, Bhandari V. Systematic use of the RAM nasal cannula in the Yale-New Haven Children's Hospital Neonatal Intensive Care Unit: a quality improvement project. J Matern Fetal Neonatal Med. 2015 Apr;28(6):718-21. doi: 10.3109/14767058.2014.929659. Epub 2014 Jun 30.
Results Reference
result

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RAM Cannula Versus Short Bi-nasal Cannula in Respiratory Distress Syndrome

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