Assessment of Outcome and Tolerability of High Velocity Nasal Insufflation and Continuous Positive Airway Pressure in Children With Acute Respiratory Distress
Phase: NA
Conditions: Community Acquired Pneumonia, Bronchiolitis
Sponsor: Ain Shams University

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Official Title of the study:
Assessment of Outcome and Tolerability of High Velocity Nasal 
Insufflation and Continuous Positive Airway Pressure in Children
with Acute Respiratory Distress
                Unique Protocol Id
                   FMASU MD 11 /2023
   Document date:
     8/1/2023

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What is already known on this subject?
What does this study add?
Acute respiratory distress is medical emergency in children and infants,
approximately 15- 20% of affected children require respiratory support and intensive care
due to a rapid emergency of respiratory distress, it’s a major cause of death in children
under 5 years.
The study will discuss which is better Nasal Continuous Positive Airway Pressure
or High Velocity Nasal Insufflation in treatment of children with acute respiratory distress
that require oxygen therapy in PICU.
1. Introduction/ Review
Acute respiratory distress is medical emergency in children and infants (Friedman
and Nitu, 2018).
Approximately 15–20% of affected children require respiratory support and
intensive care due to respiratory distress (Meissner et al., 2016).
Acute Respiratory distress is a major cause of death in children under 5 years and
approximately one million children die annually due to respiratory failure worldwide
(Walker et al., 2013).
The World Health Organization and the American Academy of Pediatrics (AAP)
both recommend oxygen supplementation at an arterial pulse oximetry (SpO2) lower than
90% because oxygen supply in children with acute lower respiratory tract infection is
associated with reduced mortality (Duke  et al., 2008).
Different modalities for oxygen supplementation in children exist,the standard flow
oxygen therapy (through a standard nasal cannula) provides oxygen without need for
humidification when the oxygen flow is either low (i.e., 1–2 L/min) or the room air has
high humidity (Ralston et al., 2014).
On the other hand, high flow rates usually require humidification due to the drying
effect of non-humidified cold oxygen on nasal secretions and the respiratory mucosa
(Franklin et al., 2018).
Non-invasive ventilation is widely used in the respiratory management of severe
cases of respiratory distress, high-flow nasal cannula (HFNC) oxygen therapy delivers
warm and humidified oxygen at a higher flow than the normal inspiratory flow (Lee  et al.,
2013).
The nasal continuous positive airway pressure is another management modality that
combines supplemental oxygen with a positive end-expiratory pressure, it has been shown
to reduce the ventilation need duration and the overall hospitalization length in children
with respiratory distress (Essouri et al., 2014).
Both CPAP and High Velocity Nasal Insufflation are high flow systems and are

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capable of generating PEEP (Pedersen and Vahlkvist, 2017).
High Velocity Nasal Insufflation is considered to be a less invasive procedure than
CPAP, better tolerated and comparatively easy to perform (Yoder et al., 2013).
This probably makes High Velocity Nasal Insufflation a preferred procedure of
choice in young children. One of the important differences between these two procedures
is that CPAP employs an integrated pressure release valvular system, whereas in High
Velocity Nasal Insufflation,the release of pressure is via the leak at the nares prong
interface and through the mouth (Pedersen and Vahlkvist, 2017).
The lack of the ability to regulate the pressure delivered to the airways in High
Velocity Nasal Insufflation may run the risk of delivering high pressures at high flow rates
if the leak is compromised (Sivieri et al., 2013).
High Velocity Nasal Insufflation is thought to work through increasing the oxygen
fraction in the alveoli by washout of the nasopharyngeal dead space, reducing the
inspiratory resistance, improvement of airway conductance and by providing an end-
distending pressure to the lungs (Dysart et al., 2019).
On similar lines, CPAP decreases the inspiratory resistance, reduces atelectasis,
reduces alveolar resistance, increases surface area of alveoli, and enhances ventilation and
perfusion (V/Q) matching through PEEP (Gupta and Donn, 2016).
A retrospective record-based study to compare CPAP with High Velocity Nasal
Insufflation among infants with respiratory distress found no significant difference in
length of hospital stay, respiratory rate, PaCO2, FiO2, or duration of oxygen supply
(Metge et al., 2014).
2.Aim/Objectives
    To study outcome & tolerability of  High Velocity Nasal Insufflation and Continuous
Positive Air way Pressure  in children with acute respiratory distress assessed by chest
ultrasound in PICU.
3. Methodology:
Patients and Methods/ Subjects and Methods/ Material and Methods
– Type of Study Design: Cohort Study Design.
– Proposed Study Design: Prospective Interventional Study.
– Study setting:  PICU, Children’s Hospital, Faculty of Medicine, Ain Shams University,
Cairo, Egypt.
– Study duration:  Two years starting from December 2022 to December 2024.
– Study population: Children aged 1 month - 5 years.
– Sampling method: Randomized sample.

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– Sample size: 80 patients will be divided into 2 groups.
Group A: Patients on high velocity nasal insufflation .
Group B: Patients on nasal continuous positive airway pressure.
Inclusion criteria (for groups A and B)
-
Patients aged from 1 month to 5 years, hospitalized in PICU with acute respiratory
distress failed on low flow nasal oxygen and need non invasive respiratory support .
Exclusion criteria: Any chronic diseases & comorbidites including
-
Cardiac diseases.
-
Neuromuscular diseases.
-
Chronic lung diseases.
-
Recurrent wheezing.
-
History of cardio-respiratory arrest.
– Study procedures:
The patients will be divided into two groups A and B, randomization will be done as
follow: group A contains the patients with odd numbers and group B contains patients
with even numbers and both groups will undergo the following:
1- Detailed medical history through patients and/or their legal guardian as well as data
retrieved from patients’ medical files compiled during admission and used for patient
follow up post discharge, with emphasis on:
a- Demographic data: age, gender, age at disease onset and consanguinity.
b- History of the present illness with emphasis on systems affected in chronological
order, with focus on respiratory affection e.g. Fever, cough, Shortness of breath,
cyanosis.
2- General physical examination and respiratory examination for any residual findings at
the time of the study, and retrieving data of examination findings from the medical
files. 
3- Results of Laboratory tests done for patients during and after hospital admission
including CBC, blood gases, inflammatory markers including CRP, ESR, blood
cultures and sputum cultures and viral respiratory panel.
4- Imaging results: chest ultrasound at day 0 then daily assessment by lung ultrasound
score. Appendix 1
5- Assessment of pain by flacc pain rating scale. Appendix 2
– Ethical Considerations: This study will be conducted after approval of the Research
Ethics Committee of Ain Shams University hospitals and an informed consent will be
obtained from the parents or caregiver of each participant.

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– Statistical analysis: Numerical data will be summarized using mean and standard
deviations or medians and inter quartile ranges. Qualitative data will be presented as
count and percentage, p-value <0.005 will be considered significant.
– Statistical package: Statistical analysis will be performed with statistical package for
social science (SPSS) version 27.
4. References
1- Bouhamed B, Mongodi S, Via G, Rouquette I (2015): Ultrasound for lung monitoring
of ventilated patients. Anesthesiology; 122(2): 437-47.
2- Duke T, Wandi F, Jonathan M, Matai S, Kaupa M, Saavu M, et al. (2008):
Improved oxygen systems for childhood pneumonia: a multihospital effectiveness
study in Papua New Guinea. The Lancet; 372(9646): 1328–33.
3-Dysart K, Miller TL, Wolfson MR, Shaffer TH (2009): Research in high flow therapy
mechanisms of action. Respir Med.; 103(10):1400-5.
4- Essouri S, Laurent M, Chevret L, Durand P, Ecochard E, Gajdos V et al. (2014):
Improved clinical and economic outcomes in bronchiolitis with pre-emptive N
CPAP ventilatory strategy. Intensive Care Med.; 40(1):84–91.
5-Franklin D, Babl FE, Schlapbach LJ, Oakley E, Craig S, Neutze J et al. (2018):
Arandomized trial of high-flow oxygen therapy in infants with peumonia. N Engl J
Med.; 378(75):1121–31.
6- Friedman ML, Nitu ME (2018): Acute respiratory failure in children. Pediatric Ann.;
47(7):e268–e273.
7- Gupta S, Donn SM (2016): Continuous positive airway pressure: physiology and
comparison of devices. Semin Fetal Neonatal Med.;  21(3):204–11.
8- Lee JH, Rehder KJ, Williford L, Cheifetz IM, Turner DA (2013): Use of high flow
nasal cannula in critically ill infant and children:a critical review of the literature.
Intensive Care Med.; 39(2):247– 57.
9- Meissner HC (2016): Viral pneumonia in children. N Engl J Med.; 374(1):62–72.
10- Voepel-Lewis T, Shayevitz JR, Malviya S (1997): The FLACC: a behavioral scale
for scoring postoperative pain in young children. Pediatr Nurs.; 23(3):293-7.
11- Metge P, Grimaldi C, Hassid S, Thomachot L, Loundou A, Martin C,
et al. (2014): Comparison of a high-flow humidified nasal cannula to nasal
continuous positive airway pressure in children with pneumonia :experience in a
pediatric intensive care unit. Eur J Pediatr.; 173(7):953–8.
12- Pedersen MB, Vahlkvist S (2017): Comparison of CPAP and HFNC in management
of  bronchiolitis in infants and young children. Children (Basel); 4(4):28.

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13- Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM,
et al. (2014): Clinical practice guideline: the diagnosis, management, and
prevention of peumonia in  Pediatrics; 134:e1474–502.
14- Sivieri EM, Gerdes JS, Abbasi S (2013): Effect of HFNC flow rate, cannula size,
and nares diameter on generated airway pressures: an in vitro study. Pediatr
Pulmonol; 48(5):506–14.
15- Walker CLF, Rudan I, Liu L, Nair H, Theodoratou E, Bhutta ZA, et al. (2013):
Global burden of childhood pneumonia and diarrhea. Lancet.; 381(9875):1405–16.
16- Yoder BA, Stoddard RA, Li M, King J, Dirnberger DR, Abbasi S (2013): Heated,
humidified high-flow nasal cannula versus nasal CPAP for respiratory support in
Pediatrics.; 131(5):e1482–90.

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Appendix 1
Lung ultrasound score (Bouhamed et al., 2015)

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Appendix 2
Flacc pain rating score (Voepel-Lewis et al., 1997)