Implementation of Nasal Non-Invasive Ventilation With a RAM Cannula in the Inpatient /Outpatient Setting
Phase: NA
Conditions: Chronic Respiratory Failure
Sponsor: The University of Texas Health Science Center, Houston

IRB NUMBER: HSC-MS-17-0708 
IRB APPROVAL DATE: 10/10/2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Implementation of Nasal Non-Invasive Ventilation with a RAM Cannula in the Inpatient / 
Outpatient Setting 
 
NCT03473171 
 
Version Date: 10/10/2017 
 
 

IRB NUMBER: HSC-MS-17-0708 
IRB APPROVAL DATE: 10/10/2017 
 
 
PROTOCOL 
 
Implementation of Nasal Non-Invasive Ventilation with a RAM Cannula in the Inpatient / 
Outpatient Setting 
 
 
Principal Investigator: 
Wilfredo De Jesus Rojas, MD 
UT Health Science Center 
 
Co-Investigators: 
Cindy Jon, MD 
UT Health Science Center 
James Stark, MD, PhD 
UT Health Science Center 
Katrina McBeth, MD 
UT Health Science Center 
Aravind Yadav, MD 
UT Health Science Center 
Ricardo Mosquera, MD 
UT Health Science Center 
 
Contact Person(s): 
Wilfredo De Jesus Rojas, MD 
The University of Texas Health Science Center at Houston 6431 Fannin St. MSB 3.228 A 
Houston, Texas 77030 
Fax: 713-500-5650 
Cindy.Jon@uth.tmc.edu 
 
 
 
Background: 
Nasal Non-invasive ventilator (NIV) can be a useful mode of respiratory support in the acute 
setting preventing endotracheal intubation [9]. It may also be use for long-term respiratory 
support in patients with chronic respiratory failure in an enhanced medical home setting 
[1]. Non-invasive continuous positive pressure can be delivery using several devices and 
modes including High-Flow Nasal Cannula (HFNC), Continuous Positive Airway Pressure 
(CPAP) and Bi-level positive airway pressure (BIPAP). The use of Nasal NIV has been 
associated with better outcomes in the intensive care setting in neonates to prevent  
invasive procedures [2-3]. Nasal NIV, using a RAM Cannula interface [Neotech], has been 
demonstrated to decrease the use of mechanical ventilation and endotracheal intubation in 
neonates[4]. 

IRB NUMBER: HSC-MS-17-0708 
IRB APPROVAL DATE: 10/10/2017 
 
 
 
Dr. Ramanathan introduced the concept of RAM Cannula as a Nasal NIV device in 2011 for 
infants in the neonatal intensive care unit. Although, the current FDA indication for RAM – 
NC is for oxygen delivery, positive pressure can be deliver at discretion and experience of 
the medical practitioner. 
 
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RAM Cannula can be used as a Nasal NIV device to improve tidal volumes, decrease the 
work of breathing, improve ventilation and oxygenation in the pediatric population[5]. In 
comparison with a regular nasal cannula [Hudson Cannula], RAM Cannulas are made of 
softer material and thinner walled prongs. Due to the increase diameter on the inner nasal 
prongs, a decrease in airflow resistance is achieved. These characteristics support the RAM 
Cannula as an optimal interface for positive pressure delivery. 
 
Our division has recently described the feasibility and utility of the use NIV using a RAM 
Nasal Cannula (NIV/RAM-NC) in the outpatient setting [1]. NIV/RAM-NC inpatient initiation 
has become more common as more data are available about the use of this new technology. 
Standardized protocols of how NIV/RAM-NC should be implemented and monitored are 
lacking here at both the inpatient and outpatient site in Children’s Memorial Hermann 
Hospital. 
 
Rationale: 
NIV/RAM-NC has the potential to improve transition from invasive ventilation to NIV. In the 
process of weaning and depending on the underline pulmonary pathophysiologic disorder, 
patients may require positive pressure for long-term management in order to be discharged 
from hospital. At this time, the availability of NIV interfaces that can be used in the 
outpatient setting are limited to BIPAP and CPAP with nasal or full-face mask. These 
approaches restrict the use of positive pressure delivery devices in the pediatric setting due 

IRB NUMBER: HSC-MS-17-0708 
IRB APPROVAL DATE: 10/10/2017 
 
 
to several factors, including: patient age, weight, mask fitness, tolerability of the interface, 
facial developmental and skin irritation and breakdowns [7-8]. We propose the 
implementation of a standardized protocol to initiate NIV/RAM-NC with Trilogy mechanical 
ventilator at the Children Memorial Hospital inpatient and outpatient site. 
 
Objectives: 
Primary Aims: 
 
Implement a standardized protocol to initiate NIV/RAM-NC with Trilogy mechanical 
ventilator at the Children Memorial Hospital inpatient and outpatient site. 
 
Secondary Aims: 
 
Explore the side effects and complications associated with the use of NIV/RAM-NC  
in children. 
 
Study Design and Methods 
 
Overview: A one-year prospective study will be conducted in order to enroll subjects to 
start NIV/RAM-NC. Demographic data, clinical diagnosis, NIV RAM Cannula mode and 
parameters, associated complications, side effects and mortality information will be 
collected from the electronic medical record at the end of the year. Descriptive statistics  
will be obtained and presented in percentage and averages. 
 
Study Population: 
Children from 0 to 21 years admitted to the Children Memorial Hermann Hospital and 
consulted to Pediatric Pulmonary Service for initiation of NIV/RAM-NC both at the inpatient 
and outpatient. 
 
Inclusion Criteria: 
Children who fail to wean from chronic respiratory support (CPAP, BiPAP, HFNC) in whom 
long-term ventilation is considered between 10/2016 – 10/2017 will be included. 
 
Exclusion Criteria: 
Children  with  minimal  setting  (CPAP  <  5cmH2O,  HFNC  <  3LPM)  able  to  be  weaned to 

IRB NUMBER: HSC-MS-17-0708 
IRB APPROVAL DATE: 10/10/2017 
 
 
regular nasal cannula and patients with upper airway obstruction that may be candidates 
for surgical procedure will be excluded. 
 
Study Procedures: 
Patient Risks: Risk related to the use of NIV/RAM-NC include: 
 
Ulceration and pressure necrosis due to the interface long-term use. 
 
Skin breakdown and ulceration of the nasal septum 
 
Abdominal distension due to aerophagia 
 
Aspiration of gastric content 
 
Nasal sinus congestion 
 
Air trapping and risk of pneumothorax (air leak) 
 
Need of further procedures (ex. chest tube) 
 
Patient Benefits: 
 
Prevent invasive procedures like tracheostomy tube cannulation 
 
Avoid the use of traditional facial interfaces for positive pressure delivery and 
their complications 
 
Potential decrease the length of the total hospitalization 
 
Study Outcomes 
Our goal is to safely initiate and monitor the use of NIV/RAM-NC implementation in the 
inpatient and outpatient setting at Children Memorial Hospital and promote an adequate 
transition to home NIV ventilation with Pediatric Pulmonary follow up. 
 
Data Analysis Plan 
At the end of the study, data will be extracted from the electronic medical record (Care4) 
McGovern Medical School, UT Health. Statistical collaboration from UT will be used for data 
analysis, if needed. Data analysis will be encrypted with a password that will be known by 
the principal investigator and research co-workers. Percentage analysis for the 
epidemiology and risk factors information from the EMR will be analyzed for each variable. 
Graphical analysis from multiple variables for hypothesis testing will be part of the study. 
 
Sample size and power 

IRB NUMBER: HSC-MS-17-0708 
IRB APPROVAL DATE: 10/10/2017 
 
 
Based on our experience about the use of NNIV with RAM Cannula, we expect to enroll 
around 50 subjects to be part of the study. No power known at this time due to the limited 
use of NIV/RAM-NC in the pediatric population and the scant literature on this topic. Our 
sample will depend on the number of patients consulted to initiate NIV/RAM-NC at the 
inpatient and outpatient setting. 
 
Limitations 
Limited use of NIV/RAM-NC in the pediatric population may affect our enrollment and 
observations. We expect to implement a protocol and describe our experience with our 
NIV/RAM-NC children cohort. 
 
Confidentiality 
Every effort will be made to protect the privacy of the subjects. Unique identifiers will not  
be stored in the final database that will be used for analytic purposes. Information such as 
age, sex, and ethnicity will be collected to examine the patterns of interaction, if any, among 
demographic subgroups. Collected data will be encrypted on a password protected USB. We 
will minimize the need to collect information about research subjects. Data will be collected 
using a linking log (saved in a different password protected USB) to avoid the use of 
identifiers and destroyed after 2 years. The need to access to research data should be based 
on a “need to know” and "minimum necessary" standard. 
 
Upon completion of the study, electronic data will be retained by the principal investigator 
(Wilfredo De Jesus Rojas, MD) at the University of Texas Medical School office (|
 
 
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All data forms will be kept in a locked file cabinet and electronic files will be password 
protected. Subjects will not be directly identifiable. The PI, co-investigators, and designated 
study staff will use the information for data analysis and manuscript preparation. 
 
NIV/RAM-NC Implementation Inpatient Protocol: 
Where will this initiative be implemented? 
 
This quality improvement project will be implemented in Children Memorial Hermann 
Hospital  inpatient  site  (Pediatric  Intensive  care  unit  [PICU]  and  Intermediate  care unit 

IRB NUMBER: HSC-MS-17-0708 
IRB APPROVAL DATE: 10/10/2017 
 
 
[IMU]) in the TMC plus at the Pediatric Pulmonary Clinics and High Risk Clinics at UTMB 
outpatient sites. 
 
How will we implement this project? 
INPATIENT: 
 
Pediatric Pulmonary Team will be consulted on patients that fail to wean from 
chronic respiratory support (CPAP, BiPAP, High flow Nasal Cannula in whom long- 
term ventilation is considered. 
 
Pediatric Pulmonary Team, as a consultant, will consider patient history, physical 
examination, previous imaging and laboratories and previous attempts to  wean 
from respiratory support and causes of failure to wean. 
 
The Pulmonary team will determine which patients would potentially benefit from 
use of NIV/RAM-NC for long-term respiratory support and will recommend 
initiation of NIV/RAM-NC. 
 
Baseline pulmonary pathophysiology to consider NIV/RAM-NC Initiation include 
inability to wean from conventional ventilator support and one or combination of 
the following: 
 
Chest Wall weakness 
 
Central control abnormalities 
 
Obstructive lung disease 
 
Restrictive lung disease 
 
o Indications for NIV/RAM-NC initiation can include: 
 
Inability to tolerate weaning from HFNC or hospital CPAP/BPAP 
without sedation 
 
Inability to tolerate conventional CPAP/BPAP mask interface 
 
Dyspnea secondary to chest wall weakness 
 
Parental desire to avoid tracheostomy tube placement 
 
Obstructive sleep apnea 
 
o Baseline workup requested before NIV/RAM-NC initiation (these would be 
standard elements of patient evaluation regardless of evaluation for 
NIV/RAM-NC) 

IRB NUMBER: HSC-MS-17-0708 
IRB APPROVAL DATE: 10/10/2017 
 
 
 
 
 
 
 
 
OUTPATIENT: 
 
Blood Gas (Assess baseline hypercapnea) 
 
Pulse oximetry monitoring (Assess baseline hypoxemia) 
 
Chest X-ray (CXR), (Evaluate baseline pulmonary disease) 
 
ENT evaluation to evaluate for upper airway anomalies that can be 
fixed surgically (if apply) 
 
Pediatric Pulmonary Team will be consulted as an outpatient on patients in whom 
long-term ventilation is considered. 
 
Pediatric Pulmonary Team, as a outpatient consultant, will evaluate patient history, 
physical examination, previous imaging and laboratories. 
 
The Pulmonary team will determine which patients would potentially benefit from 
use of NIV/RAM-NC for long-term respiratory support and will recommend 
initiation of NIV/RAM-NC in the outpatient setting. 
 
Baseline pulmonary pathophysiology to consider NIV/RAM-NC initiation could 
include one of the following or combination: 
 
Chest Wall weakness 
 
Central control abnormalities 
 
Obstructive lung disease 
 
Restrictive lung disease 
 
o Indications for NIV/RAM-NC initiation can include: 
 
Inability to tolerate conventional CPAP/BPAP mask interface 
 
Dyspnea secondary to chest wall weakness 
 
Parental desire to avoid tracheostomy tube placement 
 
Obstructive sleep apnea 
 
o Baseline workup requested before NIV/RAM-NC initiation (these would be 
standard elements of patient evaluation regardless of evaluation for 
NIV/RAM-NC) 
 
Blood Gas (Assess baseline hypercapnea) 
 
Pulse oximetry monitoring (Assess baseline hypoxemia) 
 
Chest X-ray (CXR), (Evaluate baseline pulmonary disease) 

IRB NUMBER: HSC-MS-17-0708 
IRB APPROVAL DATE: 10/10/2017 
 
 
 
ENT evaluation to evaluate for upper airway anomalies that can be 
fixed surgically (if apply) 
 
What will we measure? 
 
o Monitoring success of NIV/RAM-NC implementation will include 
 
Work of breathing improvement (clinically) 
 
Tachypnea improvement (Monitoring respiratory rate) 
 
Hypercapnea (Monitor Blood gases) 
 
Hypoxemia (Monitor pulse oximetry) 
 
CXR (Evaluation of air trapping / hyperexpansion) 
 
Interpretation and Potential Importance of Findings 
We expect to implement and describe the safeness of NIV/RAM-NC initiation in the  
pediatric population along with the epidemiology, side effect and complications associated 
with the device. The introduction of NIV/RAM-NC in the inpatient/outpatient setting is a 
consideration to avoid the invasive procedures like tracheostomies for long term ventilation 
and decrease the length of hospitalization in an enhanced medical home with adequate 
outpatient follow up. 

IRB NUMBER: HSC-MS-17-0708 
IRB APPROVAL DATE: 10/10/2017 
 
 
References: 
 
[1] Wilfredo De Jesus Roja,s Cheryl L. Samuels, Traci R. Gonzales, Katrina E. McBeth, 
Aravind Yadav, James M. Stark, Cindy Jon and Ricardo A. Mosquera. Use of Nasal Non- 
Invasive Ventilation with a RAM Cannula in the Outpatient Home Setting. The Open 
Respiratory Medicine Journal, 2017, 11, 3-00. DOI: 10.2174/187430640171101 
 
[2] Ramanathan R. Nasal respiratory support through the nares: its time has come. J 
Perinatol 2010; 30(Suppl.): S67-72. [http://dx.doi.org/10.1038/jp.2010.99] [PMID: 
20877411] 
 
[3] Nzegwu NI, Mack T, DellaVentura R, et al. Systematic use of the RAM nasal cannula in 
the Yale-New Haven Children’s Hospital Neonatal Intensive Care Unit: a quality 
improvement 
project. 
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Matern 
Fetal 
Neonatal 
Med 
2015; 
28(6): 
718-21. 
[http://dx.doi.org/10.3109/14767058.2014.929659] [PMID: 24874561] 
 
[4] Ramanathan R, Sekar KC, Rasmussen M, Bhatia J, Soll RF. Nasal intermittent positive 
pressure ventilation after surfactant treatment for respiratory distress syndrome in  
preterm infants <30 weeks’ gestation: a randomized, controlled trial. J Perinatol  2012; 
32(5): 336-43. [http://dx.doi.org/10.1038/jp.2012.1] [PMID: 22301528] 
[5] Iyer NP, Chatburn R. Evaluation of a nasal cannula in noninvasive ventilation using a 
lung 
simulator. 
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Care 
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60(4): 
508-12. 
[http://dx.doi.org/10.4187/respcare.03560] [PMID: 25492958] 
[6] Aktas S, Unal S, Aksu M, et al. Nasal HFOV with Binasal Cannula Appears Effective and 
Feasible       in       ELBW       Newborns.       J       Trop       Pediatr       2016;       62(2):       165-8. 
[http://dx.doi.org/10.1093/tropej/fmv088] [PMID: 26710797] 
[7] Fauroux B, Lavis JF, Nicot F, et al. Facial side effects during noninvasive positive 
pressure     ventilation     in     children.     Intensive     Care     Med     2005;     31(7):      965-9. 
[http://dx.doi.org/10.1007/s00134-005-2669-2] [PMID: 15924228] 
[8] Villa MP, Pagani J, Ambrosio R, Ronchetti R, Bernkopf E. Mid-face hypoplasia after long- 
term     nasal    ventilation.     Am    J    Respir    Crit     Care     Med     2002;     166(8):   1142-3. 
[http://dx.doi.org/10.1164/ajrccm.166.8.257c] [PMID: 12379564] 
[9] Yaman A, Kendirli T, Ödek Ç,et al. Efficacy of noninvasive mechanical ventilation in 
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IRB NUMBER: HSC-MS-17-0708 
IRB APPROVAL DATE: 10/10/2017